A Moderate to Severe Rheumatoid Arthritis Study | NCT01721044 | Trialant
NCT01721044
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 18, 2019Actual
Enrollment
527Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Placebo
Baricitinib
cDMARD
Countries
United States
Argentina
Australia
Austria
Belgium
Canada
Denmark
France
Germany
Greece
Israel
Italy
Japan
Mexico
Netherlands
Poland
Puerto Rico
South Korea
Spain
Switzerland
Turkey (Türkiye)
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01721044
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14058
Secondary IDs
ID
Type
Description
Link
I4V-MC-JADW
Other Identifier
Eli Lilly and Company
Brief Title
A Moderate to Severe Rheumatoid Arthritis Study
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors
Acronym
RA-BEACON
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
Jan 2013
Primary Completion Date
Jun 2014Actual
Completion Date
Sep 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
Mar 10, 2017
Results First Submitted that Met QC Criteria
Dec 18, 2017
Results First Posted Date
Jan 18, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 29, 2014
Certification/Extension First Submitted that Passed QC Review
Sep 29, 2014
Certification/Extension First Posted Date
Oct 8, 2014Estimated
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 is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to a tumor necrosis factor (TNF) inhibitor, despite ongoing treatment with conventional disease-modifying antirheumatic drugs (cDMARDs).
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
527Actual
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 once 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% (ACR20) Response - Placebo Versus Baricitinib 4 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 HAQ-DI Score - Placebo Versus Baricitinib 4 mg
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 times the upper limit of normal (ULN)
Have been treated at approved doses with at least 1 biologic tumor necrosis factor (TNF)- alpha inhibitor for at least 3 months and either:
experienced insufficient efficacy or loss of efficacy
experienced intolerance of such treatment
Have had regular use of at least 1 conventional disease-modifying antirheumatic drugs (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
Exclusion Criteria:
Have received a biologic treatment for RA within 28 days of planned randomization; have received rituximab within 6 months of planned randomization
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 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 (e.g. Fridericia's corrected QT interval >500 millisecond [msec])
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 adequately respond (nonresponders) to study drug were eligible for rescue treatment with baricitinib 4 mg 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.
Participants will continue to take background cDMARD therapy throughout study.
Baricitinib 2 mg
Baricitinib 4 mg
Placebo
Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 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 - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Week 12
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Week 12
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
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. Total scores ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.
Baseline, Week 12
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. 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. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 12
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
Week 12
Percentage of Participants Achieving ACR20 Response
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Week 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is a 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's 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 time point are deemed non-responders.
Week 12 and Week 24
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is a 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's 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 time point are deemed non-responders.
Week 12 and Week 24
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), 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. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 12
Change From Baseline in Clinical Disease Activity Index 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 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
Percentage of Participants Achieving 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 24
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
Baseline, Week 24
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.
Baseline, Week 24
Change From Baseline in Worst Joint Pain NRS
Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.
Baseline, Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale 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, 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.
Baseline, Week 12, Week 24
Change From Baseline in European Quality of Life-5 Dimensions-5 Level Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is 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. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
Baseline, Week 12, Week 24
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The WPAI-RA participant 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. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
Baseline, Week 12, Week 24
Population Pharmacokinetics (PK): Maximum Concentration at Steady State of Dosing (Cmax,ss) of Baricitinib
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.
Phoenix
Arizona
85023
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.
Tucson
Arizona
85724
United States
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Palo Alto
California
94304
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.
Upland
California
91786
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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Orlando
Florida
32806
United States
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Tamarac
Florida
33321
United States
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Tampa
Florida
33613
United States
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Boise
Idaho
83702
United States
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Indianapolis
Indiana
46260
United States
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Lansing
Michigan
48910
United States
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St Louis
Missouri
63117
United States
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Freehold
New Jersey
07728
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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Rochester
New York
14618
United States
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Oklahoma City
Oklahoma
73103
United States
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Tulsa
Oklahoma
74135
United States
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Bethlehem
Pennsylvania
18017
United States
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Philadelphia
Pennsylvania
19152
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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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
C1015ABO
Argentina
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Rosario
2000
Argentina
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San Miguel de Tucumán
T4000AXL
Argentina
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Kogarah
New South Wales
04266-010
Australia
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Maroochydore
Queensland
4558
Australia
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Fitzroy
Victoria
3065
Australia
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Graz
8036
Austria
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Vienna
1100
Austria
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Brussels
1000
Belgium
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Mons
7000
Belgium
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Toronto
Ontario
M5T 3L9
Canada
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Frederiksberg
2000
Denmark
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Glostrup Municipality
2600
Denmark
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Odense
5000
Denmark
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Montpellier
34295
France
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Paris
75679
France
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Rennes
35056
France
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Tours
3700
France
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Dresden
01067
Germany
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Hamburg
22081
Germany
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Heidelberg
69120
Germany
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Würzburg
97080
Germany
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Athens
11527
Greece
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Heraklion
71110
Greece
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Kifissia
14561
Greece
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Larissa
411 10
Greece
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Ashkelon
78278
Israel
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Beer Yaakov
70300
Israel
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Haifa
34362
Israel
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Jerusalem
91120
Israel
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Kfar Saba
44281
Israel
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Petah Tikva
49100
Israel
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Tel Aviv
64239
Israel
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Florence
50134
Italy
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Pisa
56100
Italy
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Rome
00100
Italy
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Chiba
284-0003
Japan
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Fukuoka
810-8563
Japan
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Hiroshima
730-0017
Japan
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Hokkaido
060-8648
Japan
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Japan
275-8580
Japan
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Kagawa
761-0793
Japan
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Kumamoto
861-1196
Japan
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Nagasaki
856-8562
Japan
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Okayama
700-8607
Japan
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Saitama
359-1111
Japan
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Tokyo
104-8560
Japan
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Guadalajara
44650
Mexico
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Mexico City
06090
Mexico
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Monterrey
64040
Mexico
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San Luis Potosà City
78213
Mexico
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Ubbergen
6574 NA
Netherlands
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Gdansk
80-546
Poland
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Nadarzyn
05-830
Poland
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Warsaw
02-507
Poland
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Caguas
00725
Puerto Rico
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San Juan
00927
Puerto Rico
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Santurce
00909
Puerto Rico
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Seoul
110-744
South Korea
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Santander
39008
Spain
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Seville
41010
Spain
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Valencia
46026
Spain
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Villajoyosa
03570
Spain
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Fribourg
1708
Switzerland
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Lausanne
CH-1011
Switzerland
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Zurich
8091
Switzerland
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Edirne
22030
Turkey (Türkiye)
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Gaziantep
27310
Turkey (Türkiye)
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North Shields
Tyneside
NE29 8NH
United Kingdom
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Bradford
West Yorkshire
BD5 0NA
United Kingdom
Derived
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.
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.
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.
Smolen JS, Kremer JM, Gaich CL, DeLozier AM, Schlichting DE, Xie L, Stoykov I, Rooney T, Bird P, Sanchez Burson JM, Genovese MC, Combe B. Patient-reported outcomes from a randomised phase III study of baricitinib in patients with rheumatoid arthritis and an inadequate response to biological agents (RA-BEACON). Ann Rheum Dis. 2017 Apr;76(4):694-700. doi: 10.1136/annrheumdis-2016-209821. Epub 2016 Oct 31.
Genovese MC, Kremer J, Zamani O, Ludivico C, Krogulec M, Xie L, Beattie SD, Koch AE, Cardillo TE, Rooney TP, Macias WL, de Bono S, Schlichting DE, Smolen JS. Baricitinib in Patients with Refractory Rheumatoid Arthritis. N Engl J Med. 2016 Mar 31;374(13):1243-52. doi: 10.1056/NEJMoa1507247.
Baricitinib 2 milligram (mg) administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
FG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
FG000176 subjects
FG001174 subjectsRandomized to 4mg (N=11) but received 2mg due to moderate renal impairment were included in 4mg arm
FG002177 subjects
Rescue Week 16-24
FG00056 subjects
FG00138 subjects
FG00233 subjects
COMPLETED
FG000144 subjects
FG001157 subjects
FG002158 subjects
NOT COMPLETED
FG00032 subjects
FG00117 subjects
FG00219 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0017 subjects
FG00210 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lack of Efficacy
FG00016 subjects
FG0014 subjects
FG0024 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
Physician Decision
FG0001 subjects
FG0010 subjects
FG0022 subjects
Protocol Violation
FG0001 subjects
FG0010 subjects
FG0020 subjects
Withdrawal by Subject
FG0007 subjects
FG0016 subjects
FG0021 subjects
Follow Up
Type
Comment
Milestone Data
STARTED
FG00019 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG0019 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG00220 subjectsParticipants from treatment and rescue who entered the post-treatment follow-up period.
COMPLETED
FG00019 subjects
FG0019 subjects
FG00220 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
BG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
BG002
Baricitinib 4 mg
Baricitinib 4 mg administered 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
BG000176
BG001174
BG002177
BG003527
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
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002
Duration of Rheumatoid Arthritis
Time from Symptom Onset of Rheumatoid Arthritis
Mean
Standard Deviation
Years
Title
Denominators
Categories
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002
Tender Joint Count of 68 Evaluable Joints
Tender joint count based on 68 joints.
Mean
Standard Deviation
Number of Joints
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
Swollen Joint Count of 66 Evaluable Joints
Swollen joint count based on 66 joints.
Mean
Standard Deviation
Number of Joints
Title
Denominators
Categories
ParticipantsBG000174
ParticipantsBG001174
ParticipantsBG002
High Sensitivity C-Reactive Protein (hsCRP)
Mean
Standard Deviation
milligrams/liter (mg/L)
Title
Denominators
Categories
ParticipantsBG000176
ParticipantsBG001174
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% (ACR20) Response - Placebo Versus Baricitinib 4 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000176
OG001177
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00155.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
Superiority or Other (legacy)
Secondary
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 4 mg
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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count (DAS-28) High Sensitivity C-Reactive Protein (hsCRP) - Placebo Versus Baricitinib 4 mg
DAS-28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), high sensitivity C-reactive protein (hsCRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using following formula: DAS28-hsCRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission - Simplified Disease Activity Index (SDAI) ≤3.3 - Placebo Versus Baricitinib 4 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percent of Participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Percentage of Participants Achieving ACR20 Response - Placebo Versus Baricitinib 2 mg
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in HAQ-DI Score - Placebo Versus Baricitinib 2 mg
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. Total scores 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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in the DAS28 - hsCRP - Placebo Versus Baricitinib 2 mg
DAS28 consisted of composite score of following variables: TJC28, SJC28, hsCRP (mg/mL), and Patient's Global Assessment of Disease Activity. 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. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Secondary
Percentage of Participants Achieving ACR/EULAR Remission - SDAI ≤3.3 - Placebo Versus Baricitinib 2 mg
The ACR/EULAR definitions of rheumatoid arthritis (RA) remission includes an index-based definition. The index-based definition of remission occurs with a SDAI score ≤3.3. The SDAI is a tool for measurement of disease activity in RA that integrates TJC28 (0 to 28), SJC28 (0 to 28), acute phase response using C-reactive protein (0.1 to 10.0 mg/dL), Patient's Global Assessment of Disease Activity using VAS (0 to 10.0 cm), and Physician's Global Assessment of Disease Activity using VAS (0 to 10.0 cm). Lower scores indicated less disease activity.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized or assigned per protocol. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percent of Participants
Week 12
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Percentage of Participants Achieving ACR20 Response
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. 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 using VAS, Patient's Global Assessment of Disease Activity using VAS, HAQ-DI, pain due to arthritis, and hsCRP. Participants with missing responses and participants who discontinue study or drug or are rescued before analysis time point are deemed non-responders.
Modified Intent-to-Treat (mITT) population includes all randomized participants who received at least 1 dose of the study drug. Participants will be analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is a 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's 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 time point are deemed non-responders.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percentage of Participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD 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 a 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's 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 time point are deemed non-responders.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percentage of Participants
Week 12 and Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
OG002
Secondary
Change From Baseline in DAS28 - Erythrocyte Sedimentation Rate (ESR)
DAS28 consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), 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. Total scores ranged from 1.0-9.4, where lower scores indicated less disease activity.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 12
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Secondary
Change From Baseline in Clinical Disease Activity Index 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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Measures of 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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Secondary
Percentage of Participants Achieving 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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Duration of Participant Reported Outcome - Morning Joint Stiffness
Participants reported the duration of their morning joint stiffness (MJS) in hours and minutes. The participants were asked about their duration of morning joint stiffness on the day prior to the study visit to capture actual symptoms, since the participant may have had an atypical morning routine on that day. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Median
95% Confidence Interval
Minutes
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Secondary
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
A participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no tiredness) and 10 representing (as bad as you can imagine). Participants rate their tiredness by selecting the one number that describes their worst level of tiredness during the past 24 hours. Total scores ranged from 0-10.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Worst Joint Pain NRS
Participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing (no joint pain) and 10 representing (pain as bad as you can imagine). Participants rate their joint pain by selecting the one number that describes their worst level of joint pain during the past 24 hours. Total scores ranged from 0-10.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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 PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Scale 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 includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
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.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Mean
Standard Deviation
Units on a Scale
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD 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 Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. The first component is 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. The second component is a self-perceived health score which is assessed using a VAS that ranged from 0 to 100 millimeter (mm), where 0 mm indicated the worst health you can imagine and 100 mm indicated the best health you can imagine.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized. 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, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Secondary
Percentage Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The WPAI-RA participant 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. Using 6 questions, it yields four types of scores: absenteeism (work time missed), presenteeism (impairment at work), work productivity loss (overall work impairment), and activity impairment, with outcomes expressed as impairment percentages. Percentage work time missed absenteeism: Q2/(Q2+Q4)*100, Percentage impairment while working presenteeism: Q5/10*100; Percentage overall work impairment work productivity loss: Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]*100; Percentage activity impairment activity impairment: Q6/10*100. Higher numbers indicate greater impairment and less productivity, that is, worse outcomes.
mITT population includes all randomized participants who received at least 1 dose of the study drug. Participants were analyzed according to the study drug to which they were randomized.
Posted
Mean
Standard Deviation
Percentage of Impairment
Baseline, Week 12, Week 24
ID
Title
Description
OG000
Placebo
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 2 mg
Baricitinib 2 mg administered PO QD 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 Baricitinib
All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data. Participants who initially received 2 mg with renal impairment were randomized to 4mg (N=11). Participants starting on 4mg (N=177) and participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.
Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.
Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.
Participants continued to take background cDMARD therapy throughout study.
Secondary
Population PK: Area Under the Concentration Curve Versus Time at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
All randomized participants who received at least 1 dose of study drug (during study or rescue treatment) with evaluable PK data.
Baricitinib 2 mg administered PO QD through Week 24 (N=185). Participants who were randomized to 4mg (N=11) but actually received 2 mg due to moderate renal impairment were included in the 2-mg group.
Participants continued to take background cDMARD therapy throughout study.
OG001
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24 (n=177). Participants rescued to 4mg (N=33) are included in the PK baricitinib 4 mg arm.
Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
Time Frame
Not provided
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo -Treatment Period
Placebo administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
14
176
79
176
EG001
Baricitinib 2 mg - Treatment Period
Baricitinib 2mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
8
174
105
174
EG002
Baricitinib 4 mg - Treatment Period
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
19
177
102
177
EG003
Rescue Period
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
2
127
6
127
EG004
Placebo - Follow Up Period
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
1
19
2
19
EG005
Baricitinib 2 mg - Follow Up Period
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
1
9
4
9
EG006
Baricitinib 4 mg - Follow Up Period
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
0
20
1
20
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Haemorrhagic anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG0030 events0 affected127 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected20 at risk
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Leukocytosis
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0022 events2 affected177 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Tachycardia
Cardiac disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Motion sickness
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Vertigo positional
Ear and labyrinth disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Diverticulum intestinal haemorrhagic
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Oral disorder
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Medical device complication
General disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Gastroenteritis viral
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Intervertebral discitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Tooth infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0022 events2 affected177 at risk
EG003
Vulval abscess
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected145 at risk
EG0010 events0 affected137 at risk
EG0021 events1 affected149 at risk
EG003
Accident at work
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Acetabulum fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Alcohol poisoning
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Bone contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Cardiac contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Facial bones fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Fractured sacrum
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Laceration
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Muscle rupture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Ulna fracture
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Blood alkaline phosphatase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Weight decreased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Electrolyte imbalance
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Malnutrition
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected176 at risk
EG0010 events0 affected174 at risk
EG0023 events2 affected177 at risk
EG003
Synovitis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Basilar artery thrombosis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Carpal tunnel syndrome
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Transient global amnesia
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Vertebral artery thrombosis
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Confusional state
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Delirium
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Pneumonia aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Hypertensive crisis
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Peripheral embolism
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0011 events1 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Anaemia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0014 events4 affected174 at risk
EG0021 events1 affected177 at risk
EG0030 events0 affected127 at risk
EG0040 events0 affected19 at risk
EG0050 events0 affected9 at risk
EG0060 events0 affected20 at risk
Lymphopenia
Blood and lymphatic system disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Episcleritis
Eye disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 events4 affected176 at risk
EG0015 events5 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0017 events7 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0005 events4 affected176 at risk
EG0014 events4 affected174 at risk
EG0023 events3 affected177 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG00012 events12 affected176 at risk
EG00110 events10 affected174 at risk
EG0027 events7 affected177 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0012 events2 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0004 events4 affected176 at risk
EG0013 events3 affected174 at risk
EG0022 events2 affected177 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0006 events5 affected176 at risk
EG0019 events7 affected174 at risk
EG00210 events10 affected177 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0015 events4 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Fatigue
General disorders
MedDRA 17.0
Systematic Assessment
EG0005 events5 affected176 at risk
EG0016 events6 affected174 at risk
EG0024 events3 affected177 at risk
EG003
Pyrexia
General disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0018 events7 affected174 at risk
EG0023 events3 affected177 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0007 events6 affected176 at risk
EG0017 events6 affected174 at risk
EG00212 events10 affected177 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Cervicitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected145 at risk
EG0010 events0 affected137 at risk
EG0020 events0 affected149 at risk
EG003
Conjunctivitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0003 events3 affected176 at risk
EG0014 events4 affected174 at risk
EG0027 events6 affected177 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0012 events2 affected174 at risk
EG0026 events6 affected177 at risk
EG003
Influenza
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0014 events4 affected174 at risk
EG00210 events8 affected177 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0007 events7 affected176 at risk
EG00113 events12 affected174 at risk
EG00210 events9 affected177 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0014 events4 affected174 at risk
EG0025 events5 affected177 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0015 events5 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0018 events8 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0008 events8 affected176 at risk
EG00117 events15 affected174 at risk
EG00211 events9 affected177 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0006 events6 affected176 at risk
EG00110 events7 affected174 at risk
EG00210 events8 affected177 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected145 at risk
EG0013 events3 affected137 at risk
EG0020 events0 affected149 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 17.0
Systematic Assessment
EG0004 events4 affected176 at risk
EG0014 events4 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0010 events0 affected174 at risk
EG0026 events4 affected177 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0027 events5 affected177 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0014 events4 affected174 at risk
EG0028 events6 affected177 at risk
EG003
Weight increased
Investigations
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0014 events4 affected174 at risk
EG0023 events3 affected177 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0011 events1 affected174 at risk
EG0027 events7 affected177 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0013 events3 affected174 at risk
EG0025 events5 affected177 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG00010 events8 affected176 at risk
EG0014 events3 affected174 at risk
EG0026 events5 affected177 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0006 events6 affected176 at risk
EG0018 events8 affected174 at risk
EG0026 events6 affected177 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0013 events3 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0001 events1 affected176 at risk
EG0016 events5 affected174 at risk
EG0024 events4 affected177 at risk
EG003
Neck pain
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0004 events4 affected176 at risk
EG0012 events2 affected174 at risk
EG0021 events1 affected177 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0016 events4 affected174 at risk
EG0022 events1 affected177 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 17.0
Systematic Assessment
EG0008 events7 affected176 at risk
EG0016 events5 affected174 at risk
EG00210 events8 affected177 at risk
EG003
Headache
Nervous system disorders
MedDRA 17.0
Systematic Assessment
EG00012 events11 affected176 at risk
EG00117 events17 affected174 at risk
EG00212 events12 affected177 at risk
EG003
Insomnia
Psychiatric disorders
MedDRA 17.0
Systematic Assessment
EG0000 events0 affected176 at risk
EG0010 events0 affected174 at risk
EG0020 events0 affected177 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0006 events6 affected176 at risk
EG0012 events2 affected174 at risk
EG0025 events5 affected177 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0016 events5 affected174 at risk
EG0025 events5 affected177 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 17.0
Systematic Assessment
EG0002 events2 affected176 at risk
EG0015 events5 affected174 at risk
EG0022 events2 affected177 at risk
EG003
Hypertension
Vascular disorders
MedDRA 17.0
Systematic Assessment
EG0004 events4 affected176 at risk
EG0017 events7 affected174 at risk
EG0029 events9 affected177 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
527
Title
Measurements
BG00056.0± 10.7
BG00155.1± 11.1
BG00255.9± 11.3
BG00355.7± 11.0
177
ParticipantsBG003527
Title
Measurements
Female
BG000145
BG001137
BG002149
BG003431
Male
BG00031
BG00137
BG00228
BG00396
177
ParticipantsBG003527
Title
Measurements
American Indian or Alaska Native
BG0009
BG00112
BG00211
BG00332
Asian
BG00011
BG0019
BG00212
BG00332
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG0008
BG0019
BG0027
BG00324
White
BG000147
BG001144
BG002144
BG003435
More than one race
BG0001
BG0010
BG0020
BG0031
Unknown or Not Reported
BG0000
BG0010
BG0023
BG0033
177
ParticipantsBG003527
Title
Measurements
BG0009
BG0015
BG0027
BG00321
Australia
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0008
BG0019
BG0024
BG003
Austria
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0005
BG0013
BG0028
BG003
Belgium
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0001
BG0011
BG0021
BG003
Canada
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0001
BG0014
BG0023
BG003
Denmark
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0002
BG0013
BG0021
BG003
France
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0007
BG00110
BG0027
BG003
Germany
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0008
BG0015
BG0026
BG003
Greece
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0004
BG0013
BG0022
BG003
Israel
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0009
BG0018
BG00213
BG003
Italy
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0002
BG0013
BG0023
BG003
Japan
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0006
BG0016
BG0028
BG003
Mexico
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0009
BG00112
BG00210
BG003
Netherlands
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0000
BG0011
BG0021
BG003
Poland
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG00010
BG00113
BG0029
BG003
South Korea
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0004
BG0013
BG0023
BG003
Spain
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG00010
BG0017
BG00210
BG003
Switzerland
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0001
BG0012
BG0024
BG003
Turkey
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0001
BG0011
BG0021
BG003
United Kingdom
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG0002
BG0011
BG0021
BG003
United States
ParticipantsBG000176
ParticipantsBG001174
ParticipantsBG002177
ParticipantsBG003527
Title
Measurements
BG00077
BG00174
BG00275
BG003
177
ParticipantsBG003527
Title
Measurements
BG00014.0± 9.6
BG00113.7± 8.0
BG00214.3± 9.4
BG00314.0± 9.0
177
ParticipantsBG003525
Title
Measurements
BG00028.3± 16.4
BG00131.0± 16.3
BG00228.1± 15.6
BG00329.1± 16.1
177
ParticipantsBG003525
Title
Measurements
BG00017.2± 10.8
BG00118.6± 12.3
BG00216.3± 8.9
BG00317.4± 10.8
177
ParticipantsBG003527
Title
Measurements
BG00020.64± 25.26
BG00119.87± 22.48
BG00219.76± 24.84
BG00320.09± 24.19
Units
Counts
Participants
OG000176
OG001177
Title
Denominators
Categories
Title
Measurements
OG000-0.20± 0.50
OG001-0.42± 0.49
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000174
OG001177
Title
Denominators
Categories
Title
Measurements
OG000-0.85± 1.19
OG001-1.81± 1.43
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000176
OG001177
Title
Denominators
Categories
Title
Measurements
OG0001.7
OG0015.1
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.140
Superiority or Other (legacy)
Units
Counts
Participants
OG000176
OG001174
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00148.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000176
OG001174
Title
Denominators
Categories
Title
Measurements
OG000-0.20± 0.50
OG001-0.38± 0.51
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
Superiority or Other (legacy)
Participants
OG000176
OG001174
Title
Denominators
Categories
Title
Measurements
OG000-0.85± 1.19
OG001-1.53± 1.34
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
ANCOVA
0.001
Superiority or Other (legacy)
Units
Counts
Participants
OG000176
OG001174
Title
Denominators
Categories
Title
Measurements
OG0001.7
OG0012.3
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.723
Superiority or Other (legacy)
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000176
OG001174
OG002177
Title
Denominators
Categories
Title
Measurements
OG00027.3
OG00144.8
OG00246.3
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
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided <=0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided <=0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000176
OG001174
OG002177
Title
Denominators
Categories
Week 12
Title
Measurements
OG0008.0
OG00120.1
OG00228.2
Week 24
Title
Measurements
OG00013.1
OG00123.0
OG00229.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 12
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 12
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.002
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 24
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 24
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.015
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000176
OG001174
OG002177
Title
Denominators
Categories
Week 12
Title
Measurements
OG0002.3
OG00112.6
OG00211.3
Week 24
Title
Measurements
OG0003.4
OG00113.2
OG00216.9
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
Week 12
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.002
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 12
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 24
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 24
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg administered PO QD through Week 24. Participants will continue to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000168
OG001169
OG002173
Title
Denominators
Categories
Title
Measurements
OG000-0.92± 1.21
OG001-1.52± 1.37
OG002-1.80± 1.44
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
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000170
OG001169
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-12.19± 16.96
OG001-17.17± 16.96
OG002-20.30± 16.29
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
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.009
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000170
OG001169
OG002171
Title
Denominators
Categories
Title
Measurements
OG000-12.07± 17.50
OG001-17.80± 17.50
OG002-21.26± 17.01
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
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.003
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000176
OG001174
OG002177
Title
Denominators
Categories
Title
Measurements
OG0001.1
OG0014.0
OG0026.8
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
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.012
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Regression, Logistic
If logistic regression sample size requirements are not met, the p-value from Fisher's exact test is used instead.
0.104
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000172
OG001172
OG002175
Title
Denominators
Categories
Title
Measurements
OG000-8.0(-15.0 to 0.0)
OG001-25.5(-40.0 to -15.0)
OG002-27.0(-40.0 to -15.0)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Wilcoxon (Mann-Whitney)
0.002
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Wilcoxon (Mann-Whitney)
0.004
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000172
OG001172
OG002175
Title
Denominators
Categories
Title
Measurements
OG000-1.1± 2.3
OG001-1.8± 2.7
OG002-2.0± 2.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.018
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Units
Counts
Participants
OG000172
OG001172
OG002175
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 2.4
OG001-2.1± 2.5
OG002-2.5± 2.7
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
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000170
OG001170
OG002174
Title
Denominators
Categories
Week 12
Title
Measurements
OG0005.9± 10.5
OG0018.8± 10.0
OG0028.5± 9.9
Week 24
Title
Measurements
OG0006.6± 10.7
OG0018.8± 10.4
OG0029.7± 10.7
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
Week 12
ANCOVA
0.005
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 12
ANCOVA
0.004
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 24
ANCOVA
0.002
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 24
ANCOVA
0.026
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000168
OG001168
OG002174
Title
Denominators
Categories
Week 12 MCS
Title
Measurements
OG0001.6± 10.7
OG0013.4± 9.7
OG0022.4± 10.0
Week 24 MCS
Title
Measurements
OG0002.5± 10.8
OG0013.2± 11.5
OG0023.3± 10.6
Week 12 PCS
Title
Measurements
OG0003.3± 8.0
OG0016.3± 8.8
OG0026.4± 8.8
Week 24 PCS
Title
Measurements
OG0002.4± 8.2
OG0016.4± 8.9
OG0027.0± 9.3
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
MCS Week 12
ANCOVA
0.448
2-Sided
Superiority or Other (legacy)
OG000
OG001
MCS Week 12
ANCOVA
0.058
2-Sided
Superiority or Other (legacy)
OG000
OG002
MCS Week 24
ANCOVA
0.446
2-Sided
Superiority or Other (legacy)
OG000
OG001
MCS Week 24
ANCOVA
0.401
2-Sided
Superiority or Other (legacy)
OG000
OG002
PCS Week 12
ANCOVA
0.001
2-Sided
Superiority or Other (legacy)
OG000
OG001
PCS Week 12
ANCOVA
0.001
2-Sided
Superiority or Other (legacy)
OG000
OG002
PCS Week 24
ANCOVA
0.001
2-Sided
Superiority or Other (legacy)
OG000
OG001
PCS Week 24
ANCOVA
0.001
2-Sided
Superiority or Other (legacy)
Baricitinib 2 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
Units
Counts
Participants
OG000168
OG001168
OG002173
Title
Denominators
Categories
Index Score (US Algorithm) Wk 12 (N=168,168,173)
Title
Measurements
OG0000.035± 0.167
OG0010.080± 0.152
OG0020.128± 0.148
Index Score (US Algorithm) Wk 24 (N=167,168,173)
Title
Measurements
OG0000.042± 0.166
OG0010.082± 0.170
OG0020.128± 0.157
Index Score (UK Algorithm) Wk 12 (N=168,168,173)
Title
Measurements
OG0000.052± 0.250
OG0010.116± 0.224
OG0020.191± 0.224
Index Score (UK Algorithm) Wk 24 (N=167,168,173)
Title
Measurements
OG0000.064± 0.245
OG0010.122± 0.250
OG0020.192± 0.237
Self-Perceived Health Wk 12 (N=168,168,173)
Title
Measurements
OG0004.1± 29.0
OG00114.1± 24.2
OG00210.3± 27.3
Self-Perceived Health Wk 24 (N=167,168,173)
Title
Measurements
OG0003.8± 27.8
OG00111.4± 26.5
OG00213.3± 29.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG002
Week 12, US Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 12, US Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 24, US Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 24, US Algorithm
ANCOVA
0.003
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 12, UK Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 12, UK Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG002
Week 24, UK Algorithm
ANCOVA
0.001
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG000
OG001
Week 24, UK Algorithm
ANCOVA
0.002
a priori p-value significance threshold: 2-sided ≤0.05
2-Sided
Superiority or Other (legacy)
OG002
Baricitinib 4 mg
Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.