A Study in Moderate to Severe Rheumatoid Arthritis Partic... | NCT01721057 | Trialant
NCT01721057
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 18, 2019Actual
Enrollment
684Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Placebo
Baricitinib
cDMARD
Countries
United States
Argentina
Australia
Belgium
Canada
Croatia
Czechia
Germany
Hungary
India
Italy
Japan
Mexico
Poland
Portugal
Puerto Rico
Romania
Russia
Slovakia
South Korea
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01721057
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14059
Secondary IDs
ID
Type
Description
Link
I4V-MC-JADX
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Moderate to Severe Rheumatoid Arthritis Participants
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs With Moderately to Severely Active Rheumatoid Arthritis
Acronym
RA-BUILD
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 2019
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
Dec 2012
Primary Completion Date
Sep 2014Actual
Completion Date
Dec 2014Actual
First Submitted Date
Nov 1, 2012
First Submission Date that Met QC Criteria
Nov 1, 2012
First Posted Date
Nov 2, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
May 1, 2017
Results First Submitted that Met QC Criteria
May 9, 2017
Results First Posted Date
Jun 12, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 16, 2015
Certification/Extension First Submitted that Passed QC Review
Jan 16, 2015
Certification/Extension First Posted Date
Jan 29, 2015Estimated
Last Update Submitted Date
Sep 9, 2019
Last Update Posted Date
Sep 18, 2019Actual
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)
Yes
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 purpose of this study is to determine whether baricitinib 4 milligram (mg) once daily (QD) is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had inadequate response to or are intolerant to at least 1 conventional disease-modifying antirheumatic drug (cDMARD)(cDMARD-IR [inadequate response] participants) and who have not received a biologic disease-modifying antirheumatic drug (DMARD).
Detailed Description
Not provided
Conditions Module
Conditions
Rheumatoid Arthritis
Keywords
Not provided
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
684Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo
Placebo Comparator
Placebo administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 milligram (mg) orally once daily through Week 24.
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Drug: Placebo
Drug: cDMARD
Baricitinib 2 mg
Experimental
Baricitinib 2 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
Drug: Baricitinib
Drug: cDMARD
Baricitinib 4 mg
Experimental
Baricitinib 4 mg administered orally once daily through Week 24. Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
Drug: Baricitinib
Drug: cDMARD
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Administered orally
Placebo
Baricitinib
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Week 12
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do])when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥ (greater than or equal to) 1.2 times the upper limit of normal (ULN)
Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either:
Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
For participants not receiving a cDMARD at the time of entry, the investigator will document in the participant's history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD
Exclusion Criteria:
Are currently receiving corticosteroids at doses > (greater than)10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
Are currently receiving concomitant treatment with methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
Have ever received any biologic DMARD
Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to juvenile chronic arthritis,spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis or gout(participants with secondary Sjogren's syndrome are not excluded.)
Have a diagnosis of Felty's syndrome
Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or have New York Heart Association stage IV heart failure
Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
Have an estimated glomerular filtration rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of < (less than) 40 milliliter per minute per 1.73 m^2 (mL/min/1.73 m^2)
Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 times the ULN or the most recent available total bilirubin >/=1.5 times the ULN
Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for <5 years
Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study (eg, Fridericia's corrected QT interval >500 millisecond [msec] for men and >520 msec for women)
Have symptomatic herpes simplex at the time of study enrollment
Have evidence of active or latent tuberculosis (TB)
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
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.
Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 16.
Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count at both Weeks 14 and 16 compared to baseline.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo
Placebo administered orally (PO) once daily (QD)through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
Conventional disease-modifying anti-rheumatic drug as a background therapy
Baricitinib 2 mg
Baricitinib 4 mg
Placebo
Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 12
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Week 12
Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.
Week 12
Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.
Week 12
Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.
Week 12
Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
Week 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:
Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Week 12, Week 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Week 12, Week 24
Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score
• The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Baseline, Week 24
Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
Baseline, Week 24
Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
Week 12
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
Baseline, Week 12; Baseline Week 24
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Baseline, Week 12; Baseline, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Baseline Week 12; Baseline Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
Baseline Week 12; Baseline Week 24
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
Baseline, Week 12; Baseline, Week 24
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose
Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose
United States
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.
Peoria
Arizona
85381
United States
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Phoenix
Arizona
85023
United States
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Tucson
Arizona
85724
United States
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Fresno
California
93720
United States
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La Jolla
California
92037
United States
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.
Palm Desert
California
92260
United States
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Santa Maria
California
93454
United States
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Upland
California
91786
United States
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Boulder
Colorado
80304
United States
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Denver
Colorado
80230
United States
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.
Danbury
Connecticut
06810
United States
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Trumbull
Connecticut
06611
United States
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Lewes
Delaware
19958
United States
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Boynton Beach
Florida
33472
United States
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Naples
Florida
34102
United States
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New Port Richey
Florida
34652
United States
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Orlando
Florida
32806
United States
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Palm Harbor
Florida
34684
United States
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Tampa
Florida
33614
United States
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Vernon Hills
Illinois
60061
United States
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Indianapolis
Indiana
46260
United States
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Kalamazoo
Michigan
49009
United States
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Lansing
Michigan
48910
United States
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Columbia
Missouri
65212
United States
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St Louis
Missouri
63117
United States
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Las Vegas
Nevada
89128
United States
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Freehold
New Jersey
07728
United States
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Toms River
New Jersey
08755
United States
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Albany
New York
12206
United States
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Hartsdale
New York
10530
United States
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Asheville
North Carolina
28803
United States
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Charlotte
North Carolina
28207
United States
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Middleburg Heights
Ohio
44130
United States
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Tulsa
Oklahoma
74135
United States
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Portland
Oregon
97239
United States
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Bethlehem
Pennsylvania
18017
United States
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Wyomissing
Pennsylvania
19610
United States
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Myrtle Beach
South Carolina
29572
United States
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Cypress
Texas
77429
United States
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Dallas
Texas
75231
United States
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Lubbock
Texas
79424
United States
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Nassau Bay
Texas
77058
United States
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Webster
Texas
77508
United States
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Chesapeake
Virginia
23320
United States
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Kennewick
Washington
99336
United States
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Vancouver
Washington
98664
United States
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Franklin
Wisconsin
53132
United States
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Buenos Aires
C1128AAF
Argentina
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Córdoba
5000
Argentina
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Quilmes
B1878DVC
Argentina
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San Miguel de Tucumán
4000
Argentina
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Camperdown
New South Wales
2050
Australia
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Maroochydore
Queensland
4558
Australia
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Genk
3600
Belgium
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Ghent
9000
Belgium
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Merksem
2170
Belgium
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Mons
7000
Belgium
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Kelowna
British Columbia
V1Y3G5
Canada
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Victoria
British Columbia
V8V 3P9
Canada
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Winnipeg
Manitoba
R3A 1M3
Canada
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Kitchener
Ontario
N2M 5N6
Canada
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Ottawa
Ontario
K1H 1A2
Canada
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Toronto
Ontario
M5T 2S8
Canada
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Québec
Quebec
G1W 4R4
Canada
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Trois-Rivières
Quebec
G8Z 1Y2
Canada
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Saskatoon
Saskatchewan
S7K 0H6
Canada
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Karlovac
47000
Croatia
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Osijek
31000
Croatia
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Varaždin
42000
Croatia
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Zagreb
10 000
Croatia
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Brno
61141
Czechia
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Hustopeče
693 01
Czechia
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Pardubice
530 02
Czechia
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Uherské Hradiště
686 01
Czechia
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Cologne
50937
Germany
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Gommern
39245
Germany
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Würzburg
97080
Germany
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Békéscsaba
5600
Hungary
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Budapest
1023
Hungary
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Debrecen
4043
Hungary
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Székesfehérvár
8000
Hungary
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Veszprém
8200
Hungary
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Ahmedabad
532004
India
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Attavar, Mangalore
575001
India
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Bangalore
560 054
India
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Belagavi
590 010
India
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Gurgaon
122001
India
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Hyderabaad
500072
India
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Jaipur
302006
India
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Kolkata
700 020
India
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Lucknow
226018
India
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Mumbai
400053
India
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Secunderabad
500 003
India
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Milan
20157
Italy
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Prato
50047
Italy
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Rozzano
20089
Italy
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Valeggio sul Mincio
37067
Italy
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Aichi
470-1192
Japan
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Hiroshima
730-0017
Japan
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Hokkaido
060-8648
Japan
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Kagawa
761-0793
Japan
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Okayama
700-8607
Japan
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Saitama
359-1111
Japan
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Tochigi
329- 0498
Japan
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Tokyo
104-8560
Japan
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Toyama
933-0874
Japan
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Mexicali
21200
Mexico
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Mexico City
06600
Mexico
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Bydgoszcz
85-168
Poland
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Elblag
82-300
Poland
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Gdansk
80-546
Poland
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Lodz
90-242
Poland
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Nadarzyn
05-830
Poland
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Almada
2805-267
Portugal
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Ponte de Lima
4990-041
Portugal
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Caguas
00725
Puerto Rico
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San German
00683
Puerto Rico
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San Juan
00918
Puerto Rico
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Santurce
00909
Puerto Rico
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Bucharest
011172
Romania
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Cluj-Napoca
400006
Romania
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Constanța
900591
Romania
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Moscow
115522
Russia
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Saint Petersburg
194291
Russia
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Ulyanovsk
432063
Russia
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Yaroslavl
150003
Russia
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Bratislava
83103
Slovakia
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Partizánske
95801
Slovakia
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Topoľčany
95501
Slovakia
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Gwangju
510-757
South Korea
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Incheon
400-711
South Korea
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Seoul
150-713
South Korea
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Bilbao
48013
Spain
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Getafe
28905
Spain
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Santander
39008
Spain
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Valencia
46026
Spain
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Villajoyosa
03570
Spain
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Kaohsiung City
83301
Taiwan
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Neihu Taipei
114
Taiwan
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Taichung
40201
Taiwan
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Taichung
404
Taiwan
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Taipei
10630
Taiwan
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Yong Kung City
71004
Taiwan
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London
England
SE1 9RT
United Kingdom
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Basingstoke
Hampshire
RG24 9NA
United Kingdom
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North Shields
Tyneside
NE29 8NH
United Kingdom
Derived
van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.
Wells AF, Jia B, Xie L, Valenzuela GJ, Keystone EC, Li Z, Quebe AK, Griffing K, Otawa S, Haraoui B. Efficacy of Long-Term Treatment with Once-Daily Baricitinib 2 mg in Patients with Active Rheumatoid Arthritis: Post Hoc Analysis of Two 24-Week, Phase III, Randomized, Controlled Studies and One Long-Term Extension Study. Rheumatol Ther. 2021 Jun;8(2):987-1001. doi: 10.1007/s40744-021-00317-9. Epub 2021 May 24.
Emery P, Tanaka Y, Cardillo T, Schlichting D, Rooney T, Beattie S, Helt C, Smolen JS. Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis. Arthritis Res Ther. 2020 May 15;22(1):115. doi: 10.1186/s13075-020-02199-8.
Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0.
Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.
Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.
Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.
Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.
Emery P, Blanco R, Maldonado Cocco J, Chen YC, Gaich CL, DeLozier AM, de Bono S, Liu J, Rooney T, Chang CH, Dougados M. Patient-reported outcomes from a phase III study of baricitinib in patients with conventional synthetic DMARD-refractory rheumatoid arthritis. RMD Open. 2017 Mar 21;3(1):e000410. doi: 10.1136/rmdopen-2016-000410. eCollection 2017.
Dougados M, van der Heijde D, Chen YC, Greenwald M, Drescher E, Liu J, Beattie S, Witt S, de la Torre I, Gaich C, Rooney T, Schlichting D, de Bono S, Emery P. Baricitinib in patients with inadequate response or intolerance to conventional synthetic DMARDs: results from the RA-BUILD study. Ann Rheum Dis. 2017 Jan;76(1):88-95. doi: 10.1136/annrheumdis-2016-210094. Epub 2016 Sep 29.
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
FG002
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
FG003
Rescue
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
FG004
Placebo-Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
FG005
Baricitinib 2 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
FG006
Baricitinib 4 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Includes participants who were rescued to Baricitinib 4 mg.
FG000228 subjects
FG001229 subjects
FG002227 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Received at Least 1 Dose of Study Drug
FG000228 subjects
FG001229 subjects
FG002227 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Rescued
FG00055 subjects
FG00121 subjects
FG00215 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG000200 subjects"Completers" include rescued participants.
FG001210 subjects"Completers" include rescued participants.
FG002204 subjects"Completers" include rescued participants.
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG00028 subjects
FG00119 subjects
FG00223 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00011 subjects
FG0015 subjects
FG0028 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Adverse Event
FG0007 subjects
FG00110 subjects
FG00212 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0007 subjects
FG0013 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Physician Decision
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Death
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Rescue Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants who were nonresponders based on tender/swollen joint count entered into rescue group.
FG0010 subjectsParticipants who were nonresponders based on tender/swollen joint count entered into rescue group.
FG0020 subjectsParticipants who were nonresponders based on tender/swollen joint count entered into rescue group.
FG00391 subjectsParticipants who were determined to be nonresponders based on tender/swollen joint count.
FG0040 subjects
FG0050 subjects
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00388 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0033 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow Up
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsRescued participants who entered post-treatment follow-up are included in Baricitinib 4 mg FollowUp
FG00417 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG00519 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG00622 subjectsParticipants from treatment and rescue who entered the post-treatment follow-up period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background cDMARD therapy throughout study.
BG001
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study.
BG002
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000228
BG001229
BG002227
BG003684
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
Duration of Rheumatoid Arthritis
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug and had evaluable baseline data.
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001225
ParticipantsBG002
Tender Joint Count of 68 Evaluable Joints
Mean
Standard Deviation
Number of Joints
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
Swollen Joint Count of 66 Evaluable Joints
Mean
Standard Deviation
Number of Joints
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
High Sensitivity C-Reactive Protein (hsCRP)
Mean
Standard Deviation
milligram per Liter (mg/L)
Title
Denominators
Categories
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002
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
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire - Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using non-responder imputation (NRI).
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally (PO) once daily (QD)through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg PO QD through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Title
Measurements
OG00039.5
OG00165.9
OG00261.7
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
OG002
Regression, Logistic
0.001
2-Sided
Superiority or Other (legacy)
Secondary
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do])when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Secondary
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Participant's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24.
Participants will continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Mean Duration of Morning Joint Stiffness(MJS) in the Prior 7 Days as Collected in Electronic Daily Diaries
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes into daily electronic diaries. If MJS duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit is calculated. A decrease in duration of MJS indicated an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Posted
Median
95% Confidence Interval
minutes
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated the severity of their MJS by selecting a number from 0 to 10 that best described their overall level of MJS from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in severity rating indicated an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Posted
Mean
Standard Deviation
units on a scale
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated their tiredness by selecting a number from 0 to 10 that best described their level of worst tiredness during the past 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in tiredness severity rating indicated an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Posted
Mean
Standard Deviation
units on a scale
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Mean Worst Joint Pain Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit is calculated. A decrease in joint pain severity rating indicated an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of the study drug and had at least 4 entries within any post-baseline 7-day window are included in the analysis.
Posted
Mean
Standard Deviation
units on a scale
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria:
Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 12, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis timepoint are deemed non-responders.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 12, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Change From Baseline in Measures of Clinical Disease Activity Index (CDAI) Score
• The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF) .
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Secondary
Change From Baseline in Measures of Simplified Disease Activity Index (SDAI) Score
The SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using visual analog scale (cm), and Physician's Global Assessment of Disease Activity using visual analog scale (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. The SDAI is expressed as a score on a scale with the minimum score=0 (best) to maximum score=86 (worst). A negative change from baseline indicates an improvement.
mITT population: all randomized participants who received at least 1 dose of the study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in DAS28-Erythrocyte Sedimentation Rate (DAS28-ESR)
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), Erythrocyte Sedimentation Rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission
The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
mITT population: all randomized participants who received at least 1 dose of the study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy Fatigue (FACIT-F) Scores.
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12; Baseline Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Secondary
Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)
The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 12; Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally (PO) once daily (QD) through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline Week 12; Baseline Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
mITT population: all randomized participants who received at least 1 dose of the study drug , with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
mm
Baseline Week 12; Baseline Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
mITT population: all randomized participants who received at least 1 dose of the study drug. Change from baseline includes participants with a baseline value and an observed value at the time point being summarized.
Posted
Mean
Standard Deviation
percentage of impairment
Baseline, Week 12; Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of LY3009104
All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanogram per milliliter (ng/mL)
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24:predose
ID
Title
Description
OG000
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000
Secondary
Population PK: Maximum Concentration at Steady State of Dosing (AUC,ss) of LY3009104
All randomized participants who received at least 1 dose of study drug with evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanograms per mL per hour (ng/mL*h)
Week 0: 30 and 90 minutes postdose; Week 8: 1 hour postdose; Week 12, Week 20 and Week 24; predose
ID
Title
Description
OG000
Baricitinib 2 mg
Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
All randomized participants who received at least 1 dose of study drug.
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
Placebo-Treatment Period
Placebo administered orally once daily through Week 24.
Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study.
13
228
105
228
EG001
Baricitinib 2 Mg-Treatment Period
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
6
229
108
229
EG002
Baricitinib 4 Mg-Treatment Period
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
12
227
127
227
EG003
Rescue
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
1
91
21
91
EG004
Placebo-Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
1
17
2
17
EG005
Baricitinib 2 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
0
19
0
19
EG006
Baricitinib 4 mg- Follow Up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
Includes participants who were rescued to Baricitinib 4 mg.
1
22
4
22
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG0030 affected91 at risk
EG0040 affected17 at risk
EG0050 affected19 at risk
EG0060 affected22 at risk
Angina pectoris
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Atrial fibrillation
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Ventricular tachycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Bacterial infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Disseminated tuberculosis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Pelvic abscess
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0011 events1 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Sepsis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Viral infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Wound infection staphylococcal
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Animal bite
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Patella fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Upper limb fracture
Injury, poisoning and procedural complications
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Myositis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Polymyositis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Spinal pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Synovial cyst
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Migraine
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Post-traumatic stress disorder
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Suicidal ideation
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Acute respiratory distress syndrome
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Acute respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Allergic bronchitis
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Interstitial lung disease
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Pleural effusion
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0011 events1 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Rash pruritic
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Subcutaneous emphysema
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0010 events0 affected229 at risk
EG0020 events0 affected227 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.1
Systematic Assessment
EG0006 events6 affected228 at risk
EG0016 events6 affected229 at risk
EG0024 events4 affected227 at risk
EG0030 affected91 at risk
EG0040 affected17 at risk
EG0050 affected19 at risk
EG0060 affected22 at risk
Sinus bradycardia
Cardiac disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0015 events5 affected229 at risk
EG0023 events3 affected227 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0015 events5 affected229 at risk
EG0024 events4 affected227 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0004 events3 affected228 at risk
EG0017 events7 affected229 at risk
EG0025 events5 affected227 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG00011 events10 affected228 at risk
EG00111 events10 affected229 at risk
EG0025 events4 affected227 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0011 events1 affected229 at risk
EG0025 events5 affected227 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0005 events5 affected228 at risk
EG0012 events2 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Lip disorder
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0016 events5 affected229 at risk
EG0023 events3 affected227 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0009 events8 affected228 at risk
EG0017 events7 affected229 at risk
EG0025 events5 affected227 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.1
Systematic Assessment
EG0005 events4 affected228 at risk
EG0017 events7 affected229 at risk
EG0024 events4 affected227 at risk
EG003
Fatigue
General disorders
MedDRA 17.1
Systematic Assessment
EG0005 events5 affected228 at risk
EG0013 events2 affected229 at risk
EG0025 events5 affected227 at risk
EG003
Oedema peripheral
General disorders
MedDRA 17.1
Systematic Assessment
EG0006 events6 affected228 at risk
EG0013 events3 affected229 at risk
EG0023 events3 affected227 at risk
EG003
Pyrexia
General disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0011 events1 affected229 at risk
EG0027 events5 affected227 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG00012 events11 affected228 at risk
EG0017 events6 affected229 at risk
EG0028 events7 affected227 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0001 events1 affected228 at risk
EG0014 events4 affected229 at risk
EG0029 events9 affected227 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG00019 events18 affected228 at risk
EG00110 events10 affected229 at risk
EG00222 events18 affected227 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0003 events3 affected228 at risk
EG0016 events6 affected229 at risk
EG0028 events8 affected227 at risk
EG003
Rash pustular
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0006 events6 affected228 at risk
EG0013 events3 affected229 at risk
EG0024 events4 affected227 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG00019 events18 affected228 at risk
EG00116 events14 affected229 at risk
EG00226 events24 affected227 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.1
Systematic Assessment
EG0005 events4 affected228 at risk
EG00113 events12 affected229 at risk
EG0029 events9 affected227 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0003 events2 affected228 at risk
EG0016 events5 affected229 at risk
EG0026 events5 affected227 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0002 events1 affected228 at risk
EG0013 events3 affected229 at risk
EG0027 events6 affected227 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected228 at risk
EG0018 events8 affected229 at risk
EG00217 events15 affected227 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0015 events5 affected229 at risk
EG0029 events9 affected227 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0012 events2 affected229 at risk
EG0026 events6 affected227 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG0003 events3 affected228 at risk
EG0018 events6 affected229 at risk
EG0026 events6 affected227 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.1
Systematic Assessment
EG00010 events10 affected228 at risk
EG0019 events9 affected229 at risk
EG0025 events5 affected227 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG0004 events4 affected228 at risk
EG0013 events3 affected229 at risk
EG0029 events7 affected227 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.1
Systematic Assessment
EG00010 events8 affected228 at risk
EG00117 events15 affected229 at risk
EG00210 events9 affected227 at risk
EG003
Depression
Psychiatric disorders
MedDRA 17.1
Systematic Assessment
EG0007 events7 affected228 at risk
EG0010 events0 affected229 at risk
EG0021 events1 affected227 at risk
EG003
Erectile dysfunction
Reproductive system and breast disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected39 at risk
EG0010 events0 affected45 at risk
EG0021 events1 affected40 at risk
EG003
Vulvovaginal pruritus
Reproductive system and breast disorders
MedDRA 17.1
Systematic Assessment
EG0000 events0 affected189 at risk
EG0010 events0 affected184 at risk
EG0020 events0 affected187 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0004 events3 affected228 at risk
EG00111 events9 affected229 at risk
EG00210 events9 affected227 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG0014 events4 affected229 at risk
EG0029 events9 affected227 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0004 events4 affected228 at risk
EG0011 events1 affected229 at risk
EG0026 events6 affected227 at risk
EG003
Dermatitis bullous
Skin and subcutaneous tissue disorders
MedDRA 17.1
Systematic Assessment
EG0000 affected228 at risk
EG0010 affected229 at risk
EG0020 affected227 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.1
Systematic Assessment
EG0002 events2 affected228 at risk
EG00110 events10 affected229 at risk
EG0026 events6 affected227 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
C000596027
baricitinib
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0050 subjects
FG0060 subjects
1 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
17 subjects
FG00519 subjects
FG00622 subjects
0 subjects
FG0050 subjects
FG0060 subjects
684
Title
Measurements
BG00051.4± 12.5
BG00152.2± 12.3
BG00251.8± 12.1
BG00351.8± 12.3
227
ParticipantsBG003684
Title
Measurements
Female
BG000189
BG001184
BG002187
BG003560
Male
BG00039
BG00145
BG00240
BG003124
227
ParticipantsBG003684
Title
Measurements
Hispanic or Latino
BG00012
BG00115
BG00217
BG00344
Not Hispanic or Latino
BG00045
BG00143
BG00243
BG003131
Unknown or Not Reported
BG000171
BG001171
BG002167
BG003509
227
ParticipantsBG003684
Title
Measurements
American Indian or Alaska Native
BG0003
BG0012
BG0029
BG00314
Asian
BG00060
BG00161
BG00259
BG003180
Native Hawaiian or Other Pacific Islander
BG0001
BG0010
BG0020
BG0031
Black or African American
BG00010
BG0019
BG0029
BG00328
White
BG000153
BG001156
BG002148
BG003457
More than one race
BG0001
BG0011
BG0021
BG0033
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
227
ParticipantsBG003684
Title
Measurements
BG00025
BG00121
BG00218
BG00364
Australia
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0008
BG0011
BG0026
BG003
Belgium
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0001
BG0014
BG0026
BG003
Canada
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00010
BG00110
BG0028
BG003
Croatia
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0000
BG0012
BG0022
BG003
Czech Republic
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0007
BG0015
BG0023
BG003
Germany
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0004
BG0012
BG0023
BG003
Hungary
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0007
BG0018
BG0025
BG003
India
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00019
BG00119
BG00220
BG003
Italy
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0003
BG0013
BG0024
BG003
Japan
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0008
BG0016
BG0027
BG003
Korea, Republic of
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0006
BG0017
BG0024
BG003
Mexico
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0003
BG0018
BG00211
BG003
Poland
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00018
BG00113
BG00220
BG003
Portugal
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0002
BG0012
BG0021
BG003
Romania
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0001
BG0013
BG0022
BG003
Russian Federation
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0004
BG00110
BG0026
BG003
Slovakia
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0003
BG0015
BG0023
BG003
Spain
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00014
BG00110
BG00210
BG003
Taiwan
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00026
BG00128
BG00228
BG003
United Kingdom
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG0001
BG0014
BG0020
BG003
United States
ParticipantsBG000228
ParticipantsBG001229
ParticipantsBG002227
ParticipantsBG003684
Title
Measurements
BG00058
BG00158
BG00260
BG003
225
ParticipantsBG003678
Title
Measurements
BG0007.2± 7.5
BG0017.6± 7.6
BG0027.7± 7.9
BG0037.5± 7.6
227
ParticipantsBG003684
Title
Measurements
BG00024.3± 15.0
BG00123.5± 14.1
BG00224.3± 14.0
BG00324.0± 14.3
227
ParticipantsBG003684
Title
Measurements
BG00013.1± 7.2
BG00113.6± 8.7
BG00213.5± 6.9
BG00313.4± 7.6
227
ParticipantsBG003684
Title
Measurements
BG00017.7± 20.4
BG00118.2± 21.5
BG00214.2± 14.5
BG00316.7± 19.1
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Title
Measurements
OG000-0.30± 0.45
OG001-0.52± 0.59
OG002-0.52± 0.60
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Title
Measurements
OG000-1.05± 1.23
OG001-1.83± 1.22
OG002-1.91± 1.21
Baricitinib 4 mg PO QD through week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Title
Measurements
OG0000.9
OG0019.2
OG0028.8
Units
Counts
Participants
OG000221
OG001223
OG002222
Title
Denominators
Categories
Title
Measurements
OG00060.0(50.7 to 76.7)
OG00144.4(30.0 to 60.0)
OG00234.6(23.7 to 51.4)
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000221
OG001223
OG002222
Title
Denominators
Categories
Title
Measurements
OG0004.2± 2.3
OG0013.5± 2.5
OG0023.4± 2.2
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000221
OG001223
OG002222
Title
Denominators
Categories
Title
Measurements
OG0004.5± 2.2
OG0014.0± 2.5
OG0024.0± 2.3
Baricitinib 4 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000221
OG001223
OG002222
Title
Denominators
Categories
Title
Measurements
OG0004.7± 2.2
OG0013.9± 2.5
OG0023.8± 2.2
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Week 12
Title
Measurements
OG00012.7
OG00133.6
OG00233.5
Week 24
Title
Measurements
OG00021.5
OG00141.5
OG00244.1
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Week 12
Title
Measurements
OG0003.1
OG00117.9
OG00218.1
Week 24
Title
Measurements
OG0007.9
OG00125.3
OG00224.2
Baricitinib 2 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000218
OG001224
OG002219
Title
Denominators
Categories
Title
Measurements
OG000-14.29± 16.04
OG001-20.99± 14.48
OG002-23.18± 13.47
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000218
OG001224
OG002219
Title
Denominators
Categories
Title
Measurements
OG000-14.55± 16.37
OG001-21.87± 14.99
OG002-23.78± 13.94
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000220
OG001226
OG002221
Title
Denominators
Categories
Title
Measurements
OG000-1.16± 1.27
OG001-1.89± 1.23
OG002-1.97± 1.16
Units
Counts
Participants
OG000228
OG001229
OG002227
Title
Denominators
Categories
Title
Measurements
OG0000.4
OG0017.0
OG0026.6
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000216
OG001227
OG002216
Title
Denominators
Categories
Week 12
Title
Measurements
OG0007.6± 10.3
OG0018.7± 11.1
OG0028.8± 10.6
Week 24
Title
Measurements
OG0007.8± 11.0
OG0019.2± 10.7
OG0029.7± 10.8
Baricitinib 2 mg PO QD through week 24.
Participants will continue to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg PO QD through week 24.
Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.
Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000218
OG001229
OG002219
Title
Denominators
Categories
Week 12, MCS
Title
Measurements
OG0003.3± 10.6
OG0013.6± 10.5
OG0023.3± 11.0
Week 24, MCS
Title
Measurements
OG0002.7± 11.5
OG0013.0± 10.4
OG0023.3± 11.3
Week 12, PCS
Title
Measurements
OG0004.1± 7.3
OG0017.7± 8.5
OG0027.0± 8.3
Week 24, PCS
Title
Measurements
OG0004.9± 8.0
OG0018.5± 9.0
OG0028.6± 9.0
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000216
OG001227
OG002216
Title
Denominators
Categories
Index Score (US Algorithm) Week 12
Title
Measurements
OG0000.054± 0.155
OG0010.117± 0.151
OG0020.109± 0.165
Index Score (US Algorithm) Week 24
Title
Measurements
OG0000.051± 0.149
OG0010.113± 0.172
OG0020.129± 0.173
Index Score (UK Algorithm) Week 12
Title
Measurements
OG0000.074± 0.230
OG0010.167± 0.221
OG0020.159± 0.237
Index Score (UK Algorithm) Week 24
Title
Measurements
OG0000.075± 0.218
OG0010.162± 0.254
OG0020.185± 0.250
Units
Counts
Participants
OG000216
OG001227
OG002216
Title
Denominators
Categories
Self-Perceived Health, Week 12
Title
Measurements
OG0005.7± 23.8
OG00113.4± 21.8
OG00211.5± 25.2
Self-Perceived Health, Week 24
Title
Measurements
OG0008.4± 25.1
OG00113.1± 25.8
OG00210.4± 28.8
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered orally once daily through Week 24.
Participants continued to take background cDMARD therapy throughout study.