A Study in Patients With Rheumatoid Arthritis | NCT00966875 | Trialant
NCT00966875
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
May 26, 2016Estimated
Enrollment
448Actual
Phase
Phase 2
Conditions
Rheumatoid Arthritis
Interventions
LY2439821
Placebo
Countries
United States
Argentina
Chile
Germany
India
Peru
Poland
Romania
Russia
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT00966875
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
12061
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHAK
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Patients With Rheumatoid Arthritis
Official Title
A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy
Acronym
Not provided
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Apr 2016
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 2009
Primary Completion Date
Mar 2011Actual
Completion Date
Jun 2012Actual
First Submitted Date
Aug 25, 2009
First Submission Date that Met QC Criteria
Aug 25, 2009
First Posted Date
Aug 27, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 20, 2016
Results First Submitted that Met QC Criteria
Apr 20, 2016
Results First Posted Date
May 26, 2016Estimated
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 9, 2011
Certification/Extension First Submitted that Passed QC Review
Aug 9, 2011
Certification/Extension First Posted Date
Aug 15, 2011Estimated
Last Update Submitted Date
Apr 20, 2016
Last Update Posted Date
May 26, 2016Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study is to help answer the following research questions, and not to provide treatment for Rheumatoid Arthritis (RA):
The safety of LY2439821 and any side effects that might be associated with it.
Whether LY2439821 can help participants with active RA.
How much LY2439821 should be given to participants.
Detailed Description
Study I1F-MC-RHAK is a multicenter study in participants with active RA on concomitant conventional DMARD therapy. The study is a Phase 2 study with 2 parts. Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging design and Part B is an optional, open-label extension design. Two participant populations will be evaluated in this study: bDMARD-naive participants and TNFα-IR participants. Participants in Part A receive multiple subcutaneous injections of LY2439821 [bDMARD-naive participants: 0 (placebo), 3, 10, 30, 80, or 180 mg; TNFα-IR participants: 0 (placebo), 80 or 180 mg] at Weeks 0, 1, 2, 4, 6, 8, and 10. Participants in Part B receive subcutaneous injections of LY2439821 160 mg at Weeks 16, 18, and 20, and every 4 weeks thereafter through Week 60. Participants who complete both Part A and B have a total study participation of up to approximately 72 to 84 weeks.
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
rheumatoid arthritis
RA
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
448Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
3 mg LY2439821 (bDMARD-naive population)
Experimental
3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
Biological: LY2439821
10 mg LY2439821 (bDMARD-naive population)
Experimental
10 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Biological: LY2439821
30 mg LY2439821 (bDMARD-naive population)
Experimental
30 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Biological: LY2439821
80 mg LY2439821 (bDMARD-naive population)
Experimental
80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Biological: LY2439821
180 mg LY2439821 (bDMARD-naive population)
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LY2439821
Biological
Subcutaneous
10 mg LY2439821 (bDMARD-naive population)
180 mg LY2439821 (TNFa-IR population)
180 mg LY2439821 (bDMARD-naive population)
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population
ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
You must be between the ages of 18 and 75
You must have active RA
Qualifications Specific to the bDMARD-naive Population:
You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study
Qualifications Specific to the TNFα-IR Population:
You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
You must be regularly using at least 1 conventional DMARD in a stable treatment regimen
Exclusion Criteria:
You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
You are a woman who is lactating or breast feeding
You have donated more than 300 milliliters (mL) of blood within the last month
You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
You have another serious disorder or illness
You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
You have a history of uncontrolled high blood pressure
You have clinical laboratory test results at entry that are outside the normal reference range
You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study.
If you are a post-menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
If you are a post-menopausal woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate.
If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
Exclusions Specific to the bDMARD-naive Population:
You have received any prior bDMARD therapy such as TNFα, Interleukin (IL)-1, IL-6, T-cell, or B-cell targeted therapies
You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs [such as leflunomide, azathioprine, cyclosporine, etcetera (etc.)]
You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body.
Exclusions Specific to the TNFα-IR Population:
You are currently using or recently used a bDMARD or a biologic TNFα inhibitor therapy within specified periods
You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk
You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
75 Years
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern Time (UTC/GMT-5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Genovese MC, Braun DK, Erickson JS, Berclaz PY, Banerjee S, Heffernan MP, Carlier H. Safety and Efficacy of Open-label Subcutaneous Ixekizumab Treatment for 48 Weeks in a Phase II Study in Biologic-naive and TNF-IR Patients with Rheumatoid Arthritis. J Rheumatol. 2016 Feb;43(2):289-97. doi: 10.3899/jrheum.140831. Epub 2015 Dec 15.
Participants were randomized to Part A and had the option of continuing in the open-label extension, Part B after completing Part A.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo [bDMARD-naive Population]
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Biological: LY2439821
80 mg LY2439821 (TNFa-IR population)
Experimental
80 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
Biological: LY2439821
180 mg LY2439821 (TNFa-IR population)
Experimental
180 mg LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Biological: LY2439821
Placebo (bDMARD-naive population)
Placebo Comparator
Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Drug: Placebo
Placebo (TNFa-IR population)
Placebo Comparator
Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Drug: Placebo
3 mg LY2439821 (bDMARD-naive population)
30 mg LY2439821 (bDMARD-naive population)
80 mg LY2439821 (TNFa-IR population)
80 mg LY2439821 (bDMARD-naive population)
ixekizumab
Placebo
Drug
Subcutaneous
Placebo (TNFa-IR population)
Placebo (bDMARD-naive population)
Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.
Week 12
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population
DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 - CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.
Week 12
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population
ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.
Week 12
Change From Baseline in Disease Activity Score (DAS28)-Part A
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Baseline, up to Week 12
Change From Baseline in DAS28 - Part B
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Baseline, Week 64
Percentage of Participants With ACR20/50/70 Response - Part A
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.
Week 12
Percentage of Participants With of ACR20/50/70 Response - Part B
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].
Week 64
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.
Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain." The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain". The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A
The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B
The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Baseline, Week 64
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Baseline, up to Week 12
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Baseline, Week 64
Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A
Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Week 12
Percentage of Participants in EULAR28 - Part B
Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Week 64
ACR-N - Part A
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.
Week 12
ACR-N - Part B
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.
Week 64
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A
The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
Baseline, up to Week 12
Change From Baseline in FACIT Fatigue Scale - Part B
The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
Baseline, Week 64
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
Baseline, up to Week 12
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
Baseline, Week 64
Change From Baseline in HAQ-DI - Part A
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.
Baseline, up to Week 12
Change From Baseline in HAQ-DI - Part B
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.
Baseline, Week 64
Relationship Between Exposure and Response of Individual Components of the ACR Core Set
Through Week 72
Relationship Between Exposure and Response of ACR20/50/70/N
Through Week 72
Relationship Between Exposure and Response of DAS28
Through Week 72
Relationship Between Exposure and Response of EULAR28
Through Week 72
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State
Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).
Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6
Percentage of Participants With Anti-LY2439821 Antibodies
Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.
Week 16, Week 64
United States
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La Mesa
California
91942
United States
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Palm Desert
California
92260
United States
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San Jose
California
95126
United States
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Santa Maria
California
93454
United States
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Stanford
California
94305
United States
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Westlake Village
California
91361
United States
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Denver
Colorado
80230
United States
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Washington D.C.
District of Columbia
20003
United States
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Lake Mary
Florida
32746
United States
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Melbourne
Florida
32901
United States
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Sarasota
Florida
34239
United States
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St. Petersburg
Florida
33710
United States
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Tampa
Florida
33614
United States
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Vero Beach
Florida
32962
United States
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Decatur
Georgia
30329
United States
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Rome
Georgia
30165
United States
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Idaho Falls
Idaho
83404
United States
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Springfield
Illinois
62704
United States
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Cumberland
Maryland
21502
United States
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Frederick
Maryland
21702
United States
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Wheaton
Maryland
20902
United States
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Bingham Farms
Michigan
48025
United States
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St Louis
Missouri
63117
United States
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Wilmington
North Carolina
28401
United States
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Tulsa
Oklahoma
74135
United States
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Bethlehem
Pennsylvania
18017
United States
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Sellersville
Pennsylvania
18960
United States
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Charleston
South Carolina
29407
United States
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Memphis
Tennessee
38119
United States
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Sugar Land
Texas
77479
United States
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Temple
Texas
76508
United States
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Salt Lake City
Utah
84143
United States
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Arlington
Virginia
22205
United States
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Olympia
Washington
98502
United States
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Spokane
Washington
99202
United States
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Milwaukee
Wisconsin
53217
United States
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Buenos Aires
C1425AWC
Argentina
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Quilmes
B1878DVC
Argentina
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San Juan
05400
Argentina
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San Miguel de Tucumán
4000
Argentina
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Santiago
Chile
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Freiburg im Breisgau
79106
Germany
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Hamburg
22415
Germany
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Hohenfelde
18209
Germany
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Tübingen
D-72076
Germany
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Bangalore
560079
India
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Hyderabaad
500082
India
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Jaipur
302023
India
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Secunderabad
500 003
India
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Arequipa
Peru
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Lima
Lima 27
Peru
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Pueblo Libre
Lima 21
Peru
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Bytom
41-902
Poland
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Częstochowa
42-200
Poland
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Gmina Końskie
26-200
Poland
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Kościan
64-000
Poland
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Krakow
30-510
Poland
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Poznan
60-773
Poland
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Torun
87-100
Poland
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Warsaw
02-507
Poland
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Baia Mare
430110
Romania
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Bucharest
10584
Romania
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Cluj-Napoca
400006
Romania
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Iași
700656
Romania
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Moscow
115522
Russia
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Saint Petersburg
115522
Russia
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Daejeon
302-799
South Korea
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Pusan
602-739
South Korea
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Seoul
150-713
South Korea
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Kaohsiung County
833
Taiwan
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Taichung
40201
Taiwan
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Taichung
404
Taiwan
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Taipei
100
Taiwan
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Taoyuan
333
Taiwan
Derived
Genovese MC, Greenwald M, Cho CS, Berman A, Jin L, Cameron GS, Benichou O, Xie L, Braun D, Berclaz PY, Banerjee S. A phase II randomized study of subcutaneous ixekizumab, an anti-interleukin-17 monoclonal antibody, in rheumatoid arthritis patients who were naive to biologic agents or had an inadequate response to tumor necrosis factor inhibitors. Arthritis Rheumatol. 2014 Jul;66(7):1693-704. doi: 10.1002/art.38617.
3 mg LY2439821 [bDMARD-naive Population]
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG002
10 mg LY2439821 [bDMARD-naive Population]
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG003
30 mg LY2439821 [bDMARD-naive Population]
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG004
80 mg LY2439821 [bDMARD-naive Population]
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG005
180 mg LY2439821[bDMARD-naive Population]
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG006
Placebo [TNFα-IR Population]
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
FG007
80 mg LY2439821 [TNFα-IR Population]
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG008
180 mg LY2439821 [TNFα-IR Population]
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
FG00054 subjects
FG00140 subjects
FG00235 subjects
FG00337 subjects
FG00457 subjects
FG00537 subjects
FG00664 subjects
FG00765 subjects
FG00859 subjects
Received ≥1 Doses of Study Drug
FG00054 subjects
FG00140 subjects
FG00235 subjects
FG00337 subjects
FG00457 subjects
FG00537 subjects
FG00664 subjects
FG00765 subjects
FG00859 subjects
COMPLETED
FG00048 subjects
FG00136 subjects
FG00233 subjects
FG00334 subjects
FG00452 subjects
FG00533 subjects
FG00652 subjects
FG00758 subjects
FG00851 subjects
NOT COMPLETED
FG0006 subjects
FG0014 subjects
FG0022 subjects
FG0033 subjects
FG0045 subjects
FG0054 subjects
FG00612 subjects
FG0077 subjects
FG0088 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0011 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0073 subjects
FG0083 subjects
Entry Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Parent/Caregiver Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Sponsor Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0021 subjects
FG0031 subjects
FG004
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Part B
Type
Comment
Milestone Data
STARTED
FG00046 subjectsTwo (2) participants who completed Part A did not enter Part B.
FG00136 subjects
FG00233 subjects
FG00334 subjects
FG00451 subjectsOne (1) participant who completed Part A did not enter Part B.
FG00532 subjectsOne (1) participant who completed Part A did not enter Part B.
FG00651 subjectsOne (1) participant who completed Part A did not enter Part B.
FG00757 subjectsOne (1) participant who completed Part A did not enter Part B.
FG00850 subjectsOne (1) participant who completed Part A did not enter Part B.
COMPLETED
FG00041 subjects
FG00133 subjects
FG00227 subjects
FG00331 subjects
FG004
NOT COMPLETED
FG0005 subjects
FG0013 subjects
FG0026 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG003
Full Analysis Set (FAS): All randomized participants who received at least 1 dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo [bDMARD-naive Population]
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG001
3 mg LY2439821 [bDMARD-naive Population]
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG002
10 mg LY2439821 [bDMARD-naive Population]
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG003
30 mg LY2439821 [bDMARD-naive Population
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG004
80 mg LY2439821 [bDMARD-naive Population]
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG005
180 mg LY2439821[bDMARD-naive Population]
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG006
Placebo [TNFα-IR Population]
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG007
80 mg LY2439821 [TNFα-IR Population]
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG008
180 mg LY2439821 [TNFα-IR Population]
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
BG009
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00054
BG00140
BG00235
BG00337
BG00457
BG00537
BG00664
BG00765
BG00859
BG009448
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Categorical
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
<=18 years
BG0000
BG0010
BG0020
BG003
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00052.99± 10.18
BG00152.19± 9.67
BG002
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00047
BG00133
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0009
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0002
BG0013
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
United States
Title
Measurements
BG00012
BG0019
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patient's Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patient's Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physician's Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG003
Title
Denominators
Categories
Title
Measurements
OG00034.1
OG00146.2
OG00252.2
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
OG003
OG004
OG005
Regression, Logistic
0.031
A log transformed dose was used in the model.
2-Sided
No
Superiority or Other
Secondary
Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population
ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.
Part A FAS: All randomized participants who received at least 1 dose of study drug and were TNFα-IR.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population
ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated.
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Posted
Number
log (dose) mg
Week 12
ID
Title
Description
OG000
3 mg to 180 mg LY2439821 (bDMARD-naive Population)
3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG000
Secondary
Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population
DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 - CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96.
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Posted
Number
log (dose) mg
Week 12
ID
Title
Description
OG000
3 mg to 180 mg (bDMARD-naive Population)
3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG000
Secondary
Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR50 Response in bDMARD-Naive Population
ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI.
Part A FAS: All randomized participants who received at least 1 dose of study drug and were bDMARD-naive.
Posted
Number
log (dose) mg
Week 12
ID
Title
Description
OG000
3 mg to 180 mg LY2439821 (bDMARD-naive Population)
3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Disease Activity Score (DAS28)-Part A
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
Part A FAS: All randomized participants who received at least 1 dose of study drug; last observation carried forward (LOCF).
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in DAS28 - Part B
DAS28 consisted of a composite score of the following variables: TJC28, SJC28, CRP, and PtGADA-VAS. DAS28 was calculated as: DAS28 - CRP =0.56(square root TJC28) + 0.28(square root SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. A negative change indicated an improvement.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 DAS28 results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821(bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821(bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
Percentage of Participants With ACR20/50/70 Response - Part A
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70%, respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100.
Part A FAS: All randomized participants who received at least 1 dose of study drug.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
Secondary
Percentage of Participants With of ACR20/50/70 Response - Part B
ACR20 (or ACR50 or ACR70) responders were participants with at least 20% (or 50% or 70% respectively) improvement from baseline TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants was calculated as: (number of ACR20 [or ACR50 or ACR70] responders per treatment arm) / (total number of participants per treatment arm) * 100].
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR20/50/70 results.
Posted
Number
percentage of participants
Week 64
ID
Title
Description
OG000
Placebo/160 mg LY2439821(bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part A
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
tender joints
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in Individual Components of the ACR Core Set-TJC - Part B
TJC was determined by examination of 28 joint counts that were assessed for tenderness by pressure and joint manipulation on physical examination. The participant was asked for pain sensations on these manipulations and was watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-non-tender dichotomy. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, arthrodesed joints were identified by the investigator and excluded from evaluation during the study. Any joints that required intra-articular injections during the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of tender joints ranged from 0-28. A negative change indicated fewer tender joints.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 TJC results.
Posted
Mean
Standard Deviation
tender joints
Baseline, Week 64
ID
Title
Description
OG000
Placebo/160 mg LY2439821(bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part A
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints count ranged from 0-28. A negative change indicated fewer swollen joints.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
swollen joints
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
Secondary
Change From Baseline in Individual Components of the ACR Core Set-SJC - Part B
SJC was determined by examination of 28 joint that were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. Swelling secondary to osteoarthrosis was assessed as not swollen, unless there was unmistakable fluctuation. Joint assessments for each participant were performed by the same assessor, when possible, throughout the study to minimize variation. Replaced, ankylosed, or arthrodesed joints were identified by the investigator and were excluded from evaluation during the study. Any joints that required intra-articular injections over the course of the study were excluded from evaluation from the time of the injection to the conclusion of the study. The number of swollen joints ranged from 0-28. A negative change indicated fewer swollen joints.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 SJC results.
Posted
Mean
Standard Deviation
swollen joints
Baseline, Week 64
ID
Title
Description
OG000
Placebo/160 mg LY2439821(bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
Change From Baseline in Individual Components of the ACR Core Set-PAAP VAS - Part A
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain." The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in Individual Components of the ACR Core Set-PAAP-VAS - Part B
Participants were asked to assess his/her current level of arthritis pain by marking a vertical tick on a 100-mm horizontal VAS with the left end (0 mm) marked as "no pain" and the right end (100 mm) marked "worst possible pain". The scale was administered prior to the TJC and SJC count examinations. Results were expressed in mm measured between the left end of the scale and the crossing point of the vertical line of the tick. A negative change indicated a lessening of the participant's arthritis pain.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PAAP-VAS results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
Secondary
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part A
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
Secondary
Change From Baseline in Individual Components of the ACR Core Set - PtGADA-VAS - Part B
The participant was asked to give an overall assessment of his/her current arthritis disease activity. The participants response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" to the right end (100 mm) marked "extremely active arthritis." A negative change indicated an improvement in the participant's assessment of disease activity.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PtGADA-VAS results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part A
The investigator gave an overall assessment of the severity of the participants disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
mm
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
Secondary
Change From Baseline in Individual Components of the ACR Core Set - PhGA-VAS - Part B
The investigator gave an overall assessment of the severity of the participant's disease activity. The physician's response was recorded by marking a vertical tick on a 100-mm VAS with the left end (0 mm) marked as "no arthritis activity" and the right end (100 mm) marked as "extremely active arthritis." A negative change indicated a lessening in the severity of the participant's disease activity.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 PhGA-VAS results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part A
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
mg/L
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in Individual Components of the ACR Core Set - CRP - Part B
CRP is a biological marker of disease activity. A negative change indicated an improvement in participant's disease activity.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 CRP results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
Percentage of Participants in European League Against Rheumatism Responder Index (EULAR) 28 - Part A
Assessment of participant's rheumatoid arthritis (RA) by the EULAR that is based on the DAS 28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
Secondary
Percentage of Participants in EULAR28 - Part B
Assessment of participant's RA by the EULAR that is based on the DAS28 joint count. Participants were categorized as non-responders or responders (moderate responders + good responders). Percentage of participants was calculated as: (number of responders / number of participants) * 100.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 EULAR28 results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
ACR-N - Part A
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value) / baseline value] * 100.
Part A FAS: All randomized participants who received at least 1 dose of study drug with results at Week 12; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
ACR-N - Part B
ACR-N was a continuous measure of clinical, laboratory and functional outcomes in RA that characterized the percentage of improvement in RA disease activity from baseline. The index was defined as the lowest of either: the percent change in TJC, the percent change in SJC, or the median percent change of the remaining 5 ACR core criteria: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. For each criterion, percent change was calculated as: [(post baseline value - baseline value)/baseline value] * 100.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 ACR-N results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Scale - Part A
The FACIT Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
Part A FAS: defined as all data from all randomized participants who received at least 1 dose of study drug LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in FACIT Fatigue Scale - Part B
The FACIT-Fatigue Scale was a brief participant-reported questionnaire measure of fatigue and consisted of 13 items that assessed tiredness, weakness and difficulty conducting usual activities due to fatigue. Each question was scored on a 5-point scale from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating greater fatigue. For missing data, scores were prorated using the average of the other answers in the scales as long as more than 50% of the items were answered. A negative change indicated less fatigue.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 FACIT results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
Secondary
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part A
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
minutes
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in Duration of Morning Stiffness (Minutes) - Part B
The investigator queried the participants about the duration of morning stiffness in and around their joints and the results (in minutes) were recorded by the investigator. Duration was the time from when the participants woke up to when normal activities could be resumed. Durations recorded as longer than 12 hours (720 minutes) were summarized as 720 minutes. An increase in duration from baseline indicated a joint worsening and a decrease from baseline indicated joint improvement.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 Duration of Morning Stiffness results.
Posted
Mean
Standard Deviation
minutes
Baseline, Week 64
ID
Title
Description
OG000
Placebo/160 mg LY2439821(bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Change From Baseline in HAQ-DI - Part A
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range of 0 to 3. Negative mean changes from baseline indicated improvement.
Part A FAS: All randomized participants who received at least 1 dose of study drug; LOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, up to Week 12
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Secondary
Change From Baseline in HAQ-DI - Part B
HAQ-DI was a participant-reported questionnaire that consisted of 20 questions referring to 8 domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty), and 3 (unable to do). The highest score for any question in a category was the score of that category unless special aids or devices or help from another person was required. Answers for at least 6 of the 8 disability domains were required to compute the participant's HAQ-DI score. If the participant had scores for fewer than 6 categories, the HAQ-DI score was considered missing. The HAQ-DI score was calculated as the sum of the category scores divided by the number of categories scored, with a possible scores range from 0 to 3. Negative mean changes from baseline indicated improvement.
All participants from Part A who entered the open-label portion of the study, Part B, with Week 64 HAQ-DI results.
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg/160 mg LY2439821 (bDMARD-naive Population)
Secondary
Relationship Between Exposure and Response of Individual Components of the ACR Core Set
Relationship between exposure and response in Individual Components (IC) of ACR Core Set analysis was reported in outcome measures (OMs) 10-21 as change from baseline in IC of ACR Core Sets: TJC, SJC, PAAP-VAS, PtGADA-VAS, PhGA-VAS, and CRP (Parts A and B). No further analyses were completed for individual components of ACR Core Set.
Posted
Through Week 72
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Secondary
Relationship Between Exposure and Response of ACR20/50/70/N
Relationship between exposure and response ACR20/50/70/N analysis was reported in OMs 8 and 9, as percentage of participants with ACR 20/50/70 Response (Parts A and B) and OMs 24 and 25 as percentage of participants with ACR-N (Parts A and B) respectively. No further analyses were completed for ACR20/50/70/N.
Posted
Through Week 72
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
Secondary
Relationship Between Exposure and Response of DAS28
Relationship between exposure and response of DAS28 analysis was reported in OMs 6 and 7 as change from baseline in DAS28 (Parts A and B) respectively. No further analyses were completed for DAS28.
Posted
Through Week 72
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg LY2439821 (bDMARD-naive Population)
Secondary
Relationship Between Exposure and Response of EULAR28
Relationship between exposure and response of EULAR 28 analysis was reported in OMs 22 and 23 as percentage of participants in EULAR28 (Parts A and B), respectively. No further analyses were completed for EULAR28.
Posted
Through Week 72
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg LY2439821 (bDMARD-naive Population)
Secondary
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY2439821 at Steady State
Evaluable PK concentrations from all time points, including data from placebo participants who elected active treatment in Part B, were combined and utilized in a population approach to determine the population median estimates and 90% confidence intervals at steady state. Day 0 and Week 6 postdose samples were collected as late as possible during the dosing visit (in other words, the postdose samples were collected at the end of their respective visits).
All randomized participants who received at least 1 dose of study drug in Part A and had estimable PK data, as well as, participants from Part A who entered the open-label portion of the study, Part B, and had estimable PK data.
Posted
Median
90% Confidence Interval
nanograms per milliliter (ng/mL)
Predose: Day 0, Day 1 or 2 or 3, Day 7, Weeks 6, 10, 16, 40 and 64 and Postdose: Day 0 and Week 6
ID
Title
Description
OG000
Part A: 3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG001
Part A: 10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG002
Part A: 30 mg LY2439821 (bDMARD-naive Population)
Secondary
Percentage of Participants With Anti-LY2439821 Antibodies
Treatment-emergent anti-LY2439821 antibody positive participants were defined as a titer change from baseline that was at least 2 dilutions (4-fold) increase. Participants must have had an assessment to be classified as treatment emergent antibody positive or negative.
Part A (Week 16) FAS: all randomized participants who received at least 1 dose of study drug with antibody testing performed; Part B (Week 64): All participants from Part A who entered the open-label portion of the study, part B, with baseline and at least 1 post-baseline antibody testing.
Posted
Number
percentage of participants
Week 16, Week 64
ID
Title
Description
OG000
Placebo (bDMARD-naive Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG001
3 mg LY2439821 (bDMARD-naive Population)
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg LY2439821 (bDMARD-naive Population)
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
3 mg LY2439821 (bDMARD-naive Population) Part A
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
0
40
16
40
EG001
10 mg LY2439821 (bDMARD-naive Population) Part A
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
35
16
35
EG002
30 mg LY2439821 (bDMARD-naive Population) Part A
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
37
16
37
EG003
80 mg LY2439821 (bDMARD-naive Population) Part A
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
4
57
23
57
EG004
180 mg LY2439821(bDMARD-naive Population) Part A
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
37
16
37
EG005
Placebo (bDMARD-naive Population) Part A
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
54
22
54
EG006
80 mg LY2439821 (TNFa-IR Population) Part A
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
5
65
31
65
EG007
180 mg LY2439821 (TNFa-IR Population) Part A
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
6
59
32
59
EG008
Placebo (TNFa-IR Population) Part A
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
64
32
64
EG009
3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3
36
14
36
EG010
10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
3
33
19
33
EG011
30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
2
34
12
34
EG012
80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
4
51
23
51
EG013
180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
1
32
16
32
EG014
Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
4
46
26
46
EG015
80 mg/160 mg LY2439821 (TNFa-IR Population) Part B
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
7
57
23
57
EG016
180 mg/160 mg LY2439821 (TNFa-IR Population) Part B
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
4
50
16
50
EG017
Placebo/160 mg LY2439821 (TNFa-IR Population) Part B
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
7
51
23
51
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG0030 events0 affected57 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected54 at risk
EG0060 events0 affected65 at risk
EG0072 events1 affected59 at risk
EG0080 events0 affected64 at risk
EG0090 events0 affected36 at risk
EG0100 events0 affected33 at risk
EG0110 events0 affected34 at risk
EG0120 events0 affected51 at risk
EG0130 events0 affected32 at risk
EG0140 events0 affected46 at risk
EG0150 events0 affected57 at risk
EG0160 events0 affected50 at risk
EG0171 events1 affected51 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Cardiac failure congestive
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Mitral valve incompetence
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Ventricular extrasystoles
Cardiac disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Acute vestibular syndrome
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pancreatitis acute
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Retroperitoneal haemorrhage
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Death
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Device dislocation
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Systemic inflammatory response syndrome
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Serum sickness-like reaction
Immune system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Empyema
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Meningitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Sepsis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Staphylococcal bacteraemia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Whipple's disease
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Humerus fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Multiple fractures
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pneumoconiosis
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Tendon disorder
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Breast cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Colon adenoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected31 at risk
EG003
Lung adenocarcinoma metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Ovarian cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected31 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected33 at risk
EG0010 events0 affected27 at risk
EG0020 events0 affected31 at risk
EG003
Hypoaesthesia
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Intracranial aneurysm
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Ischaemic stroke
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Syncope
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected37 at risk
EG003
Renal colic
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Renal failure acute
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Arthrodesis
Surgical and medical procedures
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Aortic aneurysm
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Shock haemorrhagic
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Leukopenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG0030 events0 affected57 at risk
EG0040 events0 affected37 at risk
EG0050 events0 affected54 at risk
EG0061 events1 affected65 at risk
EG0070 events0 affected59 at risk
EG0080 events0 affected64 at risk
EG0091 events1 affected36 at risk
EG0103 events2 affected33 at risk
EG0110 events0 affected34 at risk
EG0121 events1 affected51 at risk
EG0130 events0 affected32 at risk
EG0141 events1 affected46 at risk
EG0150 events0 affected57 at risk
EG0160 events0 affected50 at risk
EG0170 events0 affected51 at risk
Neutropenia
Blood and lymphatic system disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Conjunctivitis
Eye disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected37 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Irritable bowel syndrome
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Injection site erythema
General disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Injection site haematoma
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Injection site pain
General disorders
MedDRA 14.1
Systematic Assessment
EG0003 events1 affected40 at risk
EG0011 events1 affected35 at risk
EG0021 events1 affected37 at risk
EG003
Injection site reaction
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Oedema peripheral
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pyrexia
General disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events1 affected35 at risk
EG0022 events2 affected37 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0004 events2 affected40 at risk
EG0013 events2 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Paronychia
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected37 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0021 events1 affected37 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0023 events3 affected37 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected35 at risk
EG0023 events3 affected37 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected33 at risk
EG0011 events1 affected27 at risk
EG0020 events0 affected31 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected37 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Body temperature increased
Investigations
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0005 events3 affected40 at risk
EG0010 events0 affected35 at risk
EG0022 events1 affected37 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0012 events2 affected35 at risk
EG0022 events2 affected37 at risk
EG003
Rheumatoid nodule
Musculoskeletal and connective tissue disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Burning sensation
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0022 events2 affected37 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Headache
Nervous system disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0014 events4 affected35 at risk
EG0022 events2 affected37 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0001 events1 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected37 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected7 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 14.1
Systematic Assessment
EG0002 events2 affected40 at risk
EG0010 events0 affected35 at risk
EG0022 events1 affected37 at risk
EG003
Hypertension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0012 events2 affected35 at risk
EG0023 events2 affected37 at risk
EG003
Hypotension
Vascular disorders
MedDRA 14.1
Systematic Assessment
EG0000 events0 affected40 at risk
EG0010 events0 affected35 at risk
EG0023 events2 affected37 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
D001172
Arthritis, Rheumatoid
Ancestor Terms
ID
Term
D001168
Arthritis
D007592
Joint Diseases
D009140
Musculoskeletal Diseases
D012216
Rheumatic Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
D001327
Autoimmune Diseases
D007154
Immune System Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C549079
ixekizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0052 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0064 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
1 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0082 subjects
1 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
3 subjects
FG0050 subjects
FG0065 subjects
FG0071 subjects
FG0081 subjects
0 subjects
FG0050 subjects
FG0062 subjects
FG0071 subjects
FG0081 subjects
44 subjects
FG00526 subjects
FG00629 subjects
FG00738 subjects
FG00832 subjects
7 subjects
FG0056 subjects
FG00622 subjects
FG00719 subjects
FG00818 subjects
0 subjects
FG0041 subjects
FG0050 subjects
FG0065 subjects
FG0072 subjects
FG0082 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0031 subjects
FG0042 subjects
FG0053 subjects
FG00612 subjects
FG0079 subjects
FG0086 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0042 subjects
FG0051 subjects
FG0060 subjects
FG0070 subjects
FG0082 subjects
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
FG0072 subjects
FG0081 subjects
Withdrawal by Subject
FG0002 subjects
FG0011 subjects
FG0022 subjects
FG0031 subjects
FG0042 subjects
FG0051 subjects
FG0064 subjects
FG0075 subjects
FG0085 subjects
Entry Criteria
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0061 subjects
FG0070 subjects
FG0081 subjects
0
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Between 18 and 65 years
BG00045
BG00137
BG00230
BG00329
BG00448
BG00532
BG00659
BG00755
BG00852
BG009387
>=65 years
BG0009
BG0013
BG0025
BG0038
BG0049
BG0055
BG0065
BG00710
BG0087
BG00961
53.86
± 10.62
BG00353.03± 12.16
BG00452.60± 10.91
BG00552.21± 11.33
BG00653.19± 10.44
BG00754.74± 11.12
BG00852.43± 9.90
BG00953.08± 10.61
27
BG00331
BG00452
BG00530
BG00655
BG00757
BG00851
BG009383
Male
BG0007
BG0017
BG0028
BG0036
BG0045
BG0057
BG0069
BG0078
BG0088
BG00965
8
BG0037
BG00410
BG0056
BG00615
BG00723
BG00815
BG009100
Not Hispanic or Latino
BG00045
BG00132
BG00224
BG00329
BG00446
BG00530
BG00648
BG00741
BG00843
BG009338
Unknown or Not Reported
BG0000
BG0011
BG0023
BG0031
BG0041
BG0051
BG0061
BG0071
BG0081
BG00910
2
BG0031
BG0042
BG0054
BG0060
BG0070
BG0082
BG00916
Asian
BG00016
BG00113
BG00210
BG00312
BG00417
BG00510
BG0063
BG0074
BG0083
BG00988
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
Black or African American
BG0004
BG0012
BG0020
BG0031
BG0043
BG0051
BG0066
BG0072
BG0084
BG00923
White
BG00029
BG00120
BG00221
BG00320
BG00431
BG00522
BG00654
BG00758
BG00850
BG009305
More than one race
BG0003
BG0012
BG0022
BG0033
BG0044
BG0050
BG0061
BG0071
BG0080
BG00916
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
BG0090
8
BG0038
BG00412
BG0059
BG00633
BG00732
BG00831
BG009154
Taiwan
Title
Measurements
BG0005
BG0014
BG0023
BG0034
BG0044
BG0053
BG0061
BG0071
BG0081
BG00926
Argentina
Title
Measurements
BG0001
BG0010
BG0020
BG0031
BG0041
BG0050
BG00610
BG00711
BG00810
BG00934
Poland
Title
Measurements
BG00011
BG0018
BG0028
BG0037
BG0049
BG0057
BG00611
BG00711
BG00810
BG00982
Romania
Title
Measurements
BG0005
BG0014
BG0023
BG0034
BG0046
BG0053
BG0061
BG0071
BG0080
BG00927
Peru
Title
Measurements
BG0006
BG0014
BG0024
BG0034
BG0046
BG0054
BG0061
BG0071
BG0081
BG00931
Chile
Title
Measurements
BG0000
BG0011
BG0022
BG0030
BG0042
BG0052
BG0061
BG0072
BG0081
BG00911
Russian Federation
Title
Measurements
BG0003
BG0011
BG0020
BG0031
BG0043
BG0052
BG0061
BG0071
BG0081
BG00913
Germany
Title
Measurements
BG0000
BG0010
BG0020
BG0030
BG0041
BG0050
BG0063
BG0072
BG0082
BG0098
Korea, Republic of
Title
Measurements
BG0002
BG0012
BG0021
BG0031
BG0042
BG0051
BG0062
BG0073
BG0082
BG00916
India
Title
Measurements
BG0009
BG0017
BG0026
BG0037
BG00411
BG0056
BG0060
BG0070
BG0080
BG00946
37
OG00457
OG00537
55.0
OG00455.3
OG00554.0
Units
Counts
Participants
OG00064
OG00165
OG00259
Title
Denominators
Categories
Title
Measurements
OG00023.4
OG00140.0
OG00239.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.033
2-Sided
No
Superiority or Other
OG000
OG002
Fisher Exact
0.047
No
Superiority or Other
206
Title
Denominators
Categories
Estimated dose to achieve 10% response
Title
Measurements
OG0000.8
Estimated dose to achieve 50% response
Title
Measurements
OG0002.4
Estimated dose to achieve 90% response
Title
Measurements
OG00013.8
206
Title
Denominators
Categories
Estimated dose to achieve 10% response
Title
Measurements
OG0007.3
Estimated dose to achieve 50 % response
Title
Measurements
OG00041.5
Estimated dose to achieve 90% response
Title
Measurements
OG00097.0
206
Title
Denominators
Categories
Estimated dose to achieve 10% response
Title
Measurements
OG0007.3
Estimated dose to achieve 50% response
Title
Measurements
OG00037.9
Estimated dose to achieve 90% response
Title
Measurements
OG00081.2
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00457
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-0.818± 0.981
OG001-1.308± 1.092
OG002-1.565± 1.440
OG003-1.671± 1.193
OG004-1.686± 1.344
OG005-1.940± 1.152
OG006-0.619± 1.109
OG007-1.310± 1.303
OG008-1.571± 1.261
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.013
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.004
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG003
30 mg/160 mg LY2439821(bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821(bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821(TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821(TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821(TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00833
Title
Denominators
Categories
Title
Measurements
OG000-2.143± 1.177
OG001-1.832± 1.031
OG002-2.320± 1.292
OG003-2.277± 1.337
OG004-2.280± 1.316
OG005-2.475± 1.140
OG006-1.740± 1.460
OG007-1.604± 1.282
OG008-1.874± 1.279
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00457
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
ACR20
Title
Measurements
OG00035.2
OG00145.0
OG00242.9
OG00370.3
OG00450.9
OG00554.1
OG00623.4
OG00740.0
OG00839.0
ACR50
Title
Measurements
OG0009.3
OG00117.5
OG00228.6
OG003
ACR70
Title
Measurements
OG0001.9
OG0015.0
OG00214.3
OG003
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.227
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG002
Fisher Exact
0.306
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG003
Fisher Exact
0.001
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG004
Fisher Exact
0.070
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG005
Fisher Exact
0.058
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG007
Fisher Exact
0.033
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.047
P-value is for ACR20-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG001
Fisher Exact
0.191
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG002
Fisher Exact
0.019
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG003
Fisher Exact
0.013
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG004
Fisher Exact
0.017
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG005
Fisher Exact
0.026
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG007
Fisher Exact
0.039
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.102
P-value is for ACR50-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG001
Fisher Exact
0.388
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG002
Fisher Exact
0.033
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG003
Fisher Exact
0.039
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG004
Fisher Exact
0.199
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG000
OG005
Fisher Exact
0.039
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG007
Fisher Exact
0.696
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.112
P-value is for ACR70-NRI at Week 12.
2-Sided
No
Superiority or Other
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821(TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00040
OG00132
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
ACR20
Title
Measurements
OG00075.0
OG00165.6
OG00267.9
OG00380.6
OG00472.7
OG00580.8
OG00651.6
OG00743.9
OG00864.7
ACR50
Title
Measurements
OG00042.5
OG00137.5
OG00250.0
OG003
ACR70
Title
Measurements
OG00017.5
OG00112.5
OG00232.1
OG003
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-2.95± 5.20
OG001-6.02± 7.35
OG002-6.79± 7.67
OG003-7.05± 6.28
OG004-7.66± 8.96
OG005-8.96± 7.47
OG006-2.96± 6.31
OG007-6.02± 7.31
OG008-6.02± 6.74
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.017
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.042
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.004
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.008
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.007
P-value is for Week 12.
No
Superiority or Other
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821(TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-8.73± 6.85
OG001-8.78± 5.32
OG002-11.43± 6.54
OG003-9.55± 6.20
OG004-10.86± 7.48
OG005-10.55± 7.11
OG006-6.62± 8.39
OG007-7.35± 6.83
OG008-6.81± 6.11
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-2.69± 6.07
OG001-4.25± 5.58
OG002-6.51± 7.65
OG003-6.16± 6.44
OG004-7.49± 7.98
OG005-6.52± 6.62
OG006-1.69± 5.93
OG007-5.57± 5.51
OG008-5.15± 5.65
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.093
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.023
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.006
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.001
P-value is for Week 12.
2-Sided
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.028
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
2-Sided
No
Superiority or Other
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821(TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-7.25± 6.15
OG001-5.73± 4.95
OG002-9.06± 5.92
OG003-7.26± 5.73
OG004-8.95± 6.64
OG005-8.96± 6.06
OG006-7.32± 6.45
OG007-5.46± 6.51
OG008-6.29± 5.75
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00663
OG00765
OG00856
Title
Denominators
Categories
Title
Measurements
OG000-14.8± 23.7
OG001-18.7± 22.8
OG002-21.3± 28.4
OG003-29.8± 24.1
OG004-25.8± 23.0
OG005-25.3± 27.5
OG006-9.4± 24.0
OG007-10.3± 24.7
OG008-18.8± 26.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.247
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.315
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.006
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.042
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.055
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.365
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.005
P-value is for Week 12.
No
Superiority or Other
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-32.5± 27.8
OG001-26.2± 20.3
OG002-33.3± 33.4
OG003-36.2± 27.4
OG004-32.4± 22.6
OG005-41.2± 23.0
OG006-25.5± 22.3
OG007-16.5± 21.1
OG008-26.2± 26.2
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00663
OG00765
OG00858
Title
Denominators
Categories
Title
Measurements
OG000-19.2± 21.4
OG001-17.3± 20.9
OG002-18.5± 28.7
OG003-29.1± 23.1
OG004-22.1± 23.7
OG005-30.1± 26.9
OG006-10.1± 24.7
OG007-12.1± 27.9
OG008-21.6± 25.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.778
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.865
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.030
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.331
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.039
P-value is for Week 12..
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.292
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.003
P-value is for Week 12.
No
Superiority or Other
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00132
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00833
Title
Denominators
Categories
Title
Measurements
OG000-35.4± 26.2
OG001-24.9± 25.4
OG002-31.8± 30.4
OG003-34.8± 27.0
OG004-28.5± 24.7
OG005-39.8± 25.5
OG006-22.4± 23.2
OG007-17.8± 21.4
OG008-25.1± 23.9
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-16.0± 19.0
OG001-21.0± 15.6
OG002-21.7± 25.2
OG003-26.7± 18.1
OG004-24.5± 22.3
OG005-28.8± 24.2
OG006-8.6± 21.4
OG007-25.7± 22.2
OG008-22.0± 24.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.090
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.131
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.008
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.013
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.010
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-36.1± 21.7
OG001-30.1± 22.0
OG002-38.5± 28.4
OG003-38.0± 18.5
OG004-31.0± 20.7
OG005-44.4± 17.7
OG006-30.1± 22.5
OG007-28.9± 25.8
OG008-32.7± 25.2
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-1.575± 22.336
OG001-6.079± 10.289
OG002-9.435± 23.148
OG003-7.999± 14.740
OG004-11.968± 19.792
OG005-13.575± 25.692
OG0061.229± 14.811
OG007-9.521± 20.312
OG008-8.297± 21.955
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.012
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
<0.001
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.001
P-value is for Week 12.
No
Superiority or Other
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00630
OG00740
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-10.548± 18.555
OG001-4.556± 12.937
OG002-11.340± 23.347
OG003-7.865± 22.607
OG004-14.519± 19.260
OG005-6.860± 16.745
OG006-12.094± 28.917
OG007-10.130± 18.030
OG008-9.004± 19.698
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821 (bDMARD-naive Population])
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00663
OG00765
OG00858
Title
Denominators
Categories
Title
Measurements
OG00044.4
OG00167.5
OG00260.0
OG00375.7
OG00473.2
OG00575.7
OG00636.5
OG00760.0
OG00865.5
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.013
P-value is for Week 12 LOCF.
2-Sided
No
Superiority or Other
OG000
OG002
Fisher Exact
0.076
P-value is for Week 12 LOCF.
2-Sided
No
Superiority or Other
OG000
OG003
Fisher Exact
0.002
P-value is for Week 12 LOCF.
2-Sided
No
Superiority or Other
OG000
OG004
Fisher Exact
<0.001
P-value is for Week 12 LOCF.
2-Sided
No
Superiority or Other
OG000
OG005
Fisher Exact
0.002
P-value is for Week 12.
2-Sided
No
Superiority or Other
OG006
OG007
Fisher Exact
0.006
P-value is for Week 12 LOCF.
2-Sided
No
Superiority or Other
OG006
OG008
Fisher Exact
0.001
P-value is for Week 12.
2-Sided
No
Superiority or Other
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00833
Title
Denominators
Categories
Title
Measurements
OG00090.2
OG00181.8
OG00282.1
OG00383.9
OG00484.1
OG00588.5
OG00664.5
OG00773.2
OG00869.7
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00047
OG00136
OG00234
OG00336
OG00454
OG00535
OG00656
OG00760
OG00854
Title
Denominators
Categories
Title
Measurements
OG000-11.034± 104.809
OG001-0.699± 139786
OG00215.162± 51.130
OG00311.137± 128.516
OG00418.351± 41.493
OG00523.375± 42.173
OG006-7.356± 45.724
OG0072.264± 59.277
OG00811.541± 49.358
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.307
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
0.104
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
0.139
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
0.056
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
0.048
P-value is for Week 12.
2-Sided
No
Superiority or Other
OG006
OG007
ANCOVA
0.160
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
0.029
P-value is for Week 12.
No
Superiority or Other
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00040
OG00132
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG00036.839± 42.241
OG00133.154± 32.439
OG00239.922± 37.930
OG00334.847± 69.410
OG00438.996± 30.715
OG00549.152± 31.544
OG00622.230± 54.682
OG00714.389± 45.461
OG00830.891± 41.415
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00053
OG00140
OG00235
OG00336
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG0005.566± 9.168
OG0015.725± 8.706
OG0026.057± 13.512
OG0038.924± 9.469
OG0047.250± 9.245
OG0055.838± 7.946
OG0064.953± 9.152
OG0074.400± 8.068
OG0086.627± 8.401
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.272
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.962
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.236
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.316
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.138
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.975
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.079
P-value is for Week 12.
2-Sided
No
Superiority or Other
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG0008.390± 8.405
OG0014.879± 10.810
OG0028.500± 12.880
OG0039.177± 11.637
OG0047.295± 10.436
OG0056.038± 9.986
OG0068.323± 9.304
OG0074.341± 8.493
OG0086.647± 9.639
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00234
OG00337
OG00456
OG00537
OG00664
OG00765
OG00858
Title
Denominators
Categories
Title
Measurements
OG000-36.6± 123.7
OG001-24.3± 87.3
OG002-52.7± 142.0
OG003-71.4± 143.9
OG004-63.0± 57.0
OG005-69.0± 64.1
OG006-36.3± 137.7
OG007-62.0± 138.1
OG008-43.1± 116.7
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.982
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.276
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.050
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.010
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.046
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.017
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
ANCOVA
ANCOVA adjusted for treatment and baseline value.
0.066
P-value is for Week 12.
No
Superiority or Other
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00227
OG00331
OG00444
OG00525
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-92.1± 111.3
OG001-70.2± 112.3
OG002-55.6± 72.9
OG003-92.3± 136.7
OG004-68.8± 72.5
OG005-82.3± 79.2
OG006-61.3± 161.9
OG007-60.9± 164.7
OG008-85.9± 74.8
OG002
10 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
Units
Counts
Participants
OG00054
OG00140
OG00235
OG00337
OG00456
OG00537
OG00664
OG00765
OG00859
Title
Denominators
Categories
Title
Measurements
OG000-0.220± 0.459
OG001-0.322± 0.493
OG002-0.418± 0.693
OG003-0.537± 0.639
OG004-0.469± 0.517
OG005-0.476± 0.655
OG006-0.182± 0.458
OG007-0.223± 0.448
OG008-0.265± 0.496
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Fisher Exact
0.538
P-value is for Week 12.
No
Superiority or Other
OG000
OG002
Fisher Exact
0.515
P-value is for Week 12.
No
Superiority or Other
OG000
OG003
Fisher Exact
0.030
P-value is for Week 12.
No
Superiority or Other
OG000
OG004
Fisher Exact
0.053
P-value is for Week 12.
No
Superiority or Other
OG000
OG005
Fisher Exact
0.393
P-value is for Week 12.
No
Superiority or Other
OG006
OG007
Fisher Exact
0.077
P-value is for Week 12.
No
Superiority or Other
OG006
OG008
Fisher Exact
0.105
P-value is for Week 12.
No
Superiority or Other
3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG002
10 mg/160 mg LY2439821 (bDMARD-naive Population)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg/160 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg/160 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg/160 mg LY2439821 (bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo/160 mg LY2439821 (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg/160 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg/160 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG00041
OG00133
OG00228
OG00331
OG00444
OG00526
OG00631
OG00741
OG00834
Title
Denominators
Categories
Title
Measurements
OG000-0.616± 0.609
OG001-0.542± 0.611
OG002-0.665± 0.662
OG003-0.673± 0.705
OG004-0.554± 0.614
OG005-0.697± 0.571
OG006-0.331± 0.449
OG007-0.250± 0.460
OG008-0.309± 0.437
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Units
Counts
Participants
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
OG0080
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG003
Part A: 80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG004
Part A: 180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG005
Part A: 80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG006
Part A: 180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
OG007
Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)
160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
Units
Counts
Participants
OG00040
OG00135
OG00237
OG00357
OG00437
OG00565
OG00659
OG007390
Title
Denominators
Categories
Title
Measurements
OG000336(138 to 783)
OG0011060(352 to 2580)
OG0023230(1140 to 7970)
OG0037580(2590 to 18600)
OG00417100(6870 to 42000)
OG0057320(2740 to 17700)
OG00616200(6040 to 40600)
OG00718600(8040 to 45000)
10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG003
30 mg LY2439821 (bDMARD-naive Population)
30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG004
80 mg LY2439821 (bDMARD-naive Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG005
180 mg LY2439821(bDMARD-naive Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG006
Placebo (TNFα-IR Population)
Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG007
80 mg LY2439821 (TNFα-IR Population)
80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
OG008
180 mg LY2439821 (TNFα-IR Population)
180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.