A Study in Participants With Moderate to Severe Rheumatoi... | NCT01711359 | Trialant
NCT01711359
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Sep 19, 2019Actual
Enrollment
588Actual
Phase
Phase 3
Conditions
Rheumatoid Arthritis
Interventions
Baricitinib
Methotrexate
Baricitinib Placebo
MTX Placebo
Folic Acid
Countries
United States
Argentina
Austria
Belgium
Brazil
Canada
Germany
Greece
India
Italy
Japan
Mexico
Portugal
Puerto Rico
Russia
South Africa
South Korea
Sweden
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT01711359
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14062
Secondary IDs
ID
Type
Description
Link
I4V-MC-JADZ
Other Identifier
Eli Lilly and Company
Brief Title
A Study in Participants With Moderate to Severe Rheumatoid Arthritis
Official Title
A Randomized, Double-Blind, Active-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Baricitinib (LY3009104) in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had Limited or No Treatment With Disease-Modifying Antirheumatic Drugs
Acronym
RA-BEGIN
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
Nov 2012
Primary Completion Date
Feb 2015Actual
Completion Date
Aug 2015Actual
First Submitted Date
Oct 18, 2012
First Submission Date that Met QC Criteria
Oct 18, 2012
First Posted Date
Oct 22, 2012Estimated
Results Waived
Not provided
Results First Submitted Date
Mar 10, 2017
Results First Submitted that Met QC Criteria
Jul 14, 2017
Results First Posted Date
Aug 15, 2017Actual
Certification/Extension (aka Delayed Results) First Submitted Date
May 8, 2015
Certification/Extension First Submitted that Passed QC Review
May 8, 2015
Certification/Extension First Posted Date
May 25, 2015Estimated
Last Update Submitted Date
Sep 9, 2019
Last Update Posted Date
Sep 19, 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 therapy alone is noninferior to methotrexate (MTX) therapy alone in the treatment of moderate to severe active rheumatoid arthritis (RA) in those who have had limited or no treatment with MTX and are naive to other conventional or biologic disease-modifying antirheumatic drugs (DMARDs).
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
588Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Baricitinib + MTX
Experimental
Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Drug: Baricitinib
Drug: Methotrexate
Drug: Folic Acid
Baricitinib
Experimental
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Drug: Baricitinib
Drug: MTX Placebo
Drug: Folic Acid
MTX
Active Comparator
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Drug: Methotrexate
Drug: Baricitinib Placebo
Drug: Folic Acid
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Baricitinib
Drug
Administered orally
Baricitinib
Baricitinib + MTX
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
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 ≥1.2 times the upper limit of normal (ULN)
Have had limited or no treatment with methotrexate (MTX)
Exclusion Criteria:
Have received conventional disease-modifying antirheumatic drugs (DMARDs) other than MTX (eg, gold salts, cyclosporine, leflunomide, azathioprine, hydroxychloroquine, sulfasalazine or any other immunosuppressives)
Are currently receiving corticosteroids at doses >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
Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
Have ever received any biologic DMARD
Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require a 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 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 <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
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.
Landewe R, Sun L, Chen YF, Daojun M, van der Heijde D. Robust analyses for radiographic progression in rheumatoid arthritis. RMD Open. 2023 Apr;9(2):e002543. doi: 10.1136/rmdopen-2022-002543.
Taylor PC, Alten R, Alvaro Gracia JM, Kaneko Y, Walls C, Quebe A, Jia B, Bello N, Terres JR, Fleischmann R. Achieving pain control in early rheumatoid arthritis with baricitinib monotherapy or in combination with methotrexate versus methotrexate monotherapy. RMD Open. 2022 Mar;8(1):e001994. doi: 10.1136/rmdopen-2021-001994.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants who did not respond (nonresponders) to study drug were eligible for rescue treatment beginning at Week 24.
Nonresponders were defined as lack of improvement of at least 20% in both tender joint count and swollen joint count.
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Methotrexate
Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Baricitinib placebo administered orally once daily.
MTX
MTX Placebo
Drug
MTX placebo administered orally once weekly.
Baricitinib
Folic Acid
Drug
Administered orally every day
Baricitinib
Baricitinib + MTX
MTX
Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.
Baseline, Week 24
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 24
Change From Baseline in the Modified Total Sharp Score (mTSS)
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.
Baseline, Week 24
Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
Week 24
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician'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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Week 12, Week 24, Week 52
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician'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 discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.
Week 12, Week 24, Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
Baseline, Week 24; Baseline, Week 52
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
Baseline, Week 24; Baseline, Week 52
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission
The ACR/EULAR definitions of RA remission include a "Boolean-based definition". The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
Week 12, Week 24, Week 52
Change From Baseline in Joint Space Narrowing and Bone Erosion Scores
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).
Baseline, Week 24; Baseline, Week 52
Change From Baseline in Duration of 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 the day of the study visit. 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 52
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine".
Baseline, Week 24; Baseline Week 52
Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine".
Baseline, Week 24; Baseline Week 52
Change From Baseline in Mental Component Score (MCS) and 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 (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
Baseline, Week 24; Baseline Week 52
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
Baseline, Week 24; Baseline Week 52
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
Baseline, Week 24; Baseline Week 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-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 24; Baseline Week 52
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
Baseline, Week 24; Baseline Week 52
Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib
Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib
Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
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.
Mesa
Arizona
85202
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Peoria
Arizona
85381
United States
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
85037
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.
El Cajon
California
92020
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.
Lakewood
California
90712
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palm Desert
California
92260
United States
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.
Tustin
California
92780
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.
Boulder
Colorado
80304
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.
Trumbull
Connecticut
06611
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.
Lewes
Delaware
19958
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.
Boynton Beach
Florida
33472
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.
Naples
Florida
34102
United States
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Orlando
Florida
32806
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Palm Harbor
Florida
34684
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.
Plantation
Florida
33324
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.
Tampa
Florida
33614
United States
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Venice
Florida
34292
United States
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Vernon Hills
Illinois
60061
United States
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Indianapolis
Indiana
46260
United States
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Cumberland
Maryland
21502
United States
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Grand Rapids
Michigan
49546
United States
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Lansing
Michigan
48910
United States
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Flowood
Mississippi
39232
United States
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St Louis
Missouri
63141
United States
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Freehold
New Jersey
07728
United States
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Toms River
New Jersey
08755
United States
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Albuquerque
New Mexico
87102
United States
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Hartsdale
New York
10530
United States
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Middleburg Heights
Ohio
44130
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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Portland
Oregon
97239
United States
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Duncansville
Pennsylvania
16635
United States
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Wyomissing
Pennsylvania
19610
United States
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Jackson
Tennessee
38305
United States
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Dallas
Texas
75231
United States
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Grapevine
Texas
76051
United States
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Houston
Texas
77084
United States
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Lubbock
Texas
79424
United States
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Nassau Bay
Texas
77058
United States
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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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Clarksburg
West Virginia
26301
United States
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Franklin
Wisconsin
53132
United States
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Buenos Aires
C1128AAF
Argentina
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Caba
C1440AAD
Argentina
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Córdoba
5000
Argentina
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La Plata
B1902COS
Argentina
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Mar del Plata
B7600FZN
Argentina
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Quilmes
1878
Argentina
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Rosario
2000
Argentina
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San Fernando
1646
Argentina
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San Juan
5400
Argentina
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San Miguel de Tucumán
4000
Argentina
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San Miguel de Tucumán
T4000AXL
Argentina
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Vienna
1100
Austria
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Brussels
1200
Belgium
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Genk
3600
Belgium
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Ghent
9000
Belgium
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Liège
4000
Belgium
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Mons
7000
Belgium
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Curitiba
80030-110
Brazil
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Goiânia
74110-120
Brazil
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São Paulo
04266-010
Brazil
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Edmonton
Alberta
T5M 0H4
Canada
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Victoria
British Columbia
V8V 3P9
Canada
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Winnipeg
Manitoba
R3A 1M3
Canada
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Kitchener
Ontario
N2M 5N6
Canada
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Ottawa
Ontario
K1H 1A2
Canada
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Saint Catherines
Ontario
L2N 7E4
Canada
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Trois-Rivières
Quebec
G8Z 1Y2
Canada
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Saskatoon
Saskatchewan
S7K 0H6
Canada
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Bad Nauheim
61231
Germany
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Bayreuth
95444
Germany
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Berlin
13125
Germany
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Gommern
39245
Germany
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Hamburg
22081
Germany
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Munich
80336
Germany
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Ampelokipoi
11527
Greece
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Heraklion
71110
Greece
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Kifissia
14561
Greece
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Larissa
41221
Greece
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Ahmedabad
532004
India
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Attavar, Mangalore
575001
India
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Bangalore
560 054
India
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Belagavi
590 010
India
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Hyderabaad
500072
India
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Jaipur
302006
India
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Kolkata
700 020
India
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Lucknow
226 014
India
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Mumbai
400053
India
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New Delhi
110 076
India
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Florence
50139
Italy
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Genova
16132
Italy
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Milan
20157
Italy
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Monza
20900
Italy
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Torino
10154
Italy
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Valeggio sul Mincio
37067
Italy
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Aichi
466-8560
Japan
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Chiba
284-0003
Japan
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Fukuoka
807-8556
Japan
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Hiroshima
733-0032
Japan
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Hokkaido
063-0811
Japan
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Hyōgo
665-0827
Japan
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Ibaraki
316-0015
Japan
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Japan
275-8580
Japan
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Kagawa
761-0793
Japan
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Kagoshima
899-5117
Japan
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Kanagawa
236-0004
Japan
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Kumamoto
861-1196
Japan
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Mie
510-0016
Japan
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Nagano
380-8582
Japan
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Nagasaki
857-1195
Japan
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Niigata
940-2085
Japan
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Numakunai
020-0015
Japan
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Okayama
700-8607
Japan
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Okinawa
901-0243
Japan
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Saitama
359-1111
Japan
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Shizuoka
430-8558
Japan
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Tokyo
160-8582
Japan
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Toyama
933-0874
Japan
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Guadalajara
44620
Mexico
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Monterrey
64040
Mexico
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San Luis Potosí City
78213
Mexico
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Lisbon
1050
Portugal
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Porto
4200-319
Portugal
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Caguas
00725
Puerto Rico
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Carolina
00983
Puerto Rico
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San German
00683
Puerto Rico
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San Juan
00927
Puerto Rico
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Santurce
00909
Puerto Rico
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Moscow
115522
Russia
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Ryazan
390026
Russia
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Ulyanovsk
432063
Russia
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Yaroslavl
150003
Russia
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Bloemfontein
9301
South Africa
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Durban
4092
South Africa
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Greenacres
6057
South Africa
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Somerset West
7135
South Africa
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Stellenbosch
7600
South Africa
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Daejeon
301-721
South Korea
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Incheon
405-760
South Korea
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Seoul
134-727
South Korea
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Gothenburg
SE 413 45
Sweden
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Huddinge
141 87
Sweden
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Malmö
SE-20502
Sweden
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Cambridge
Cambridgeshire
CB2 0QQ
United Kingdom
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London
Greater London
SE1 9RT
United Kingdom
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Basingstoke
Hampshire
RG24 9NA
United Kingdom
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Southampton
Hants
SO16 6YD
United Kingdom
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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.
van der Heijde D, Kartman CE, Xie L, Beattie S, Schlichting D, Mo D, Durez P, Tanaka Y, Fleischmann R. Radiographic Progression of Structural Joint Damage Over 5 Years of Baricitinib Treatment in Patients With Rheumatoid Arthritis: Results From RA-BEYOND. J Rheumatol. 2022 Feb;49(2):133-141. doi: 10.3899/jrheum.210346. Epub 2021 Sep 15.
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.
Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
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.
Schiff M, Takeuchi T, Fleischmann R, Gaich CL, DeLozier AM, Schlichting D, Kuo WL, Won JE, Carmack T, Rooney T, Durez P, Shaikh S, Hidalgo RP, van Vollenhoven R, Zerbini CAF. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.
Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.
FG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
FG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
FG000213 subjects
FG001160 subjects
FG002215 subjects
Received at Least One Dose of Study Drug
FG000210 subjects
FG001159 subjects
FG002215 subjects
Rescued
FG00026 subjects
FG0017 subjects
FG0026 subjects
COMPLETED
FG000161 subjects
FG001136 subjects
FG002173 subjects
NOT COMPLETED
FG00052 subjects
FG00124 subjects
FG00242 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00018 subjects
FG0017 subjects
FG00213 subjects
Lack of Efficacy
FG00013 subjects
FG0012 subjects
FG0022 subjects
Adverse Event
FG0008 subjects
FG00110 subjects
FG00224 subjects
Physician Decision
FG0004 subjects
FG0013 subjects
FG0022 subjects
Death
FG0003 subjects
FG0010 subjects
FG0020 subjects
Entry Criteria Not Met
FG0001 subjects
FG0010 subjects
FG0020 subjects
Sponsor Decision
FG0001 subjects
FG0010 subjects
FG0020 subjects
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0021 subjects
Randomized, Not Treated
FG0003 subjects
FG0011 subjects
FG0020 subjects
Follow Up
Type
Comment
Milestone Data
STARTED
FG00025 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG00115 subjectsParticipants from treatment who entered the post-treatment follow-up period.
FG00228 subjectsParticipants from treatment and rescue who entered the post-treatment follow-up period.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
NOT COMPLETED
FG00025 subjects
FG00115 subjects
FG00228 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
Methotrexate
Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
BG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
BG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000210
BG001159
BG002215
BG003584
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
Title
Measurements
BG00050.5± 13.4
BG00150.9± 13.0
BG00248.5± 13.5
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG000148
BG001121
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG00011
BG00110
BG002
Region of Enrollment
Count of Participants
Participants
Title
Denominators
Categories
Argentina
Title
Measurements
BG00041
BG00129
BG002
Duration of Rheumatoid Arthritis
Median
Inter-Quartile Range
years
Title
Denominators
Categories
Title
Measurements
BG0000.2(0.1 to 0.6)
BG0010.2(0.1 to 1.1)
BG002
Tender Joint Count of 68 evaluable joints
Mean
Standard Deviation
number of joints
Title
Denominators
Categories
Title
Measurements
BG00026.5± 14.8
BG00126.4± 14.1
BG002
Swollen Joint Count of 66 evaluable joints
Mean
Standard Deviation
number of joints
Title
Denominators
Categories
Title
Measurements
BG00016.4± 10.6
BG00116.1± 9.2
BG002
High sensitivity C-reactive protein
Mean
Standard Deviation
milligrams per liter (mg/L)
Title
Denominators
Categories
Title
Measurements
BG00022.34± 21.78
BG00123.75± 26.24
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).
Posted
Number
Percent of participants
Week 24
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Title
Measurements
OG00061.9
OG00176.7
OG00278.1
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
Newcombe-Wilson method
14.8
2-Sided
95
5.5
24.1
Estimation Parameter: Newcombe-Wilson method without continuity correction for difference in the response rate (Baricitinib minus Methotrexate).
Non-Inferiority or Equivalence (legacy)
Noninferiority is concluded if the lower bound of the 95% CI for the difference in response rate is >-12%
Secondary
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
ACR20 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis (RA). "ACR20 Responder" is a participant who has at least 20% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity using visual analog scale (VAS), Health Assessment Questionnaire-Disability Index (HAQ-DI), pain due to arthritis, and high-sensitivity C-reactive protein (hsCRP). Participants with missing responses and participants who discontinued study or drug or were rescued before analysis time point were deemed non-responders.
Modified Intent-to-Treat (mITT) population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using nonresponder imputation (NRI).
Posted
Number
Percent of participants
Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
HAQ-DI 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 are averaged to calculate the HAQ-DI score, which ranges from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicates an improvement in the participant's condition.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified baseline observation carried forward (mBOCF).
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mBOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in the Modified Total Sharp Score (mTSS)
X-rays of the hands/wrists and feet were scored for structural progression as measured using the mTSS (van der Heijde 2000). This methodology quantified the extent of bone erosions and joint space narrowing for 44 and 42 joints, with higher scores representing greater damage.
The mTSS at a time point is the sum of the erosion (range from 0 to 280) and JSN (range from 0 to 168) scores, for a maximum score of 448.
mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessments. Missing values due to discontinuation of study, rescue, or missing data were imputed using linear extrapolation (LE).
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
SDAI is a tool for measurement of disease activity in RA that integrates TJC28, SJC28, acute phase response using C-reactive protein (milligrams per liter), Patient's Global Assessment of Disease Activity using VAS centimeters (cm), and Physician's Global Assessment of Disease Activity using VAS (cm). The SDAI is calculated by summing the values of the 5 components. Lower scores indicated less disease activity. An index-based definition of remission occurs with an SDAI score ≤3.3.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response
ACR50 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR50 Responder" is a participant who has at least 50% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician'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 discontinued study or drug or were rescued before analysis time point were deemed non-responders.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percent of participants
Week 12, Week 24, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response
ACR70 Responder Index is composite of clinical, laboratory, and functional measures in RA. "ACR70 Responder" is a participant who has at least 70% improvement in both tender and swollen joint counts and in at least 3 of the following 5 criteria: Physician'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 discontinued study or drug or were rescued before analysis timepoint were deemed non-responders.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
Percent of participants
Week 12, Week 24, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
The CDAI is a tool for measurement of disease activity in RA that does not require a laboratory component and was scored by the investigative site. It integrates TJC28 (scored 0-28 with higher scores indicating higher disease activity), SJC28 (scored 0-28 with higher scores indicating higher disease activity), Patient's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity), and Physician's Global Assessment of Disease Activity (scored on a visual analogue scale from 0-10 cm with higher scores indicating higher disease activity). The CDAI is calculated by summing the values of the 4 components. CDAI scores range from 0 to 76; lower scores indicated lower disease activity. A negative change from baseline indicates improvement in condition.
mITT population: all randomized participants who received at least 1 dose of study drug with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using modified last observation carried forward (mLOCF).
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR)
DAS28 consisted of a composite score of the following variables: tender joint count (TJC28), swollen joint count (SJC28), erythrocyte sedimentation rate (ESR) (millimeters per hour), and Patient's Global Assessment of Disease Activity. DAS28 was calculated using the following formula: DAS28-ESR=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.70*natural log(ESR)+0.014*Patient's Global VAS. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Percentage of Participants Achieving American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Remission
The ACR/EULAR definitions of RA remission include a "Boolean-based definition". The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.
mITT population: all randomized participants who received at least 1 dose of study drug. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using NRI.
Posted
Number
percentage of participants
Week 12, Week 24, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Joint Space Narrowing and Bone Erosion Scores
X-rays of the hands/wrists and feet were assessed for joint space narrowing (JSN) and bone erosions. Assessment of JSN for each hand (15 joints per hand) and foot (6 joints per foot), including subluxation, is scored from 0 to 4, with 0 indicating no (normal) JSN and 4 indicating complete loss of joint space, bony ankylosis or luxation. JSN scores ranged from 0-168. A score of 0 would indicate no change and higher scores represent a worsening of joint space narrowing. The bone erosion score is a summary of erosion severity in 32 joints of the hands and 12 joints of the feet. Each joint is scored according to the surface area involved from 0 to 5 for hand joints and 0 to 10 for the foot joints, with 0 indicating no erosion and the highest score (5 for the hand and 10 for the foot) indicating extensive loss of bone from more than one half of the articulating bone. Erosion scores ranged from 0 (no erosion) to 280 (high erosion).
mITT population: all randomized participants who received at least 1 dose of study drug and had baseline and at least 1 post-baseline assessment. Missing values due to discontinuation of study, rescue, or missing data were imputed using LE.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Duration of 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 the day of the study visit. 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: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Median
95% Confidence Interval
Minutes
Baseline, Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Worst Tiredness Numeric Rating Scale (NRS)
Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine".
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Secondary
Change From Baseline in Worst Joint Pain Numeric Rating Scale (NRS)
Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine".
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Secondary
Change From Baseline in Mental Component Score (MCS) and 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 (MCS and PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores
European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) is a standardized measure of health status of the participant. One component consists of a descriptive system of the respondent's health comprised of the following 5 participant-reported dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The responses are used to derive the health state index scores using the United Kingdom (UK) algorithm, with scores ranging from -0.594 to 1, and the United States (US) algorithm, with scores ranging from -0.109 to 1. A higher score indicates better health state.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Secondary
Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)
A second component of the EQ-5D-5L is a self-perceived health score which is assessed using a VAS that ranges from 0 to 100 millimeter (mm), where 0 indicates the worst health you can imagine and 100 indicates the best health you can imagine.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
millimeter
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and at least 1 post-baseline value. Missing values due to discontinuation of study or drug, rescue, or missing data were imputed using mLOCF.
Posted
Mean
Standard Deviation
units on a scale
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores
The Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) questionnaire was developed to measure the effect of general health and symptom severity on work productivity and regular activities in the 7 days prior to the visit. It contains 6 items covering overall work productivity (health), overall work productivity (symptom), impairment of regular activities (health), and impairment of regular activities (symptom). Scores are calculated as impairment percentages. The WPAI-RA yields four types of scores: Absenteeism (work time missed), Presenteeism (impairment at work), Work productivity loss (overall work impairment), and Activity impairment.
mITT population: all randomized participants who received at least 1 dose of study drug, with a baseline value and an observed value at the time point being summarized.
Posted
Mean
Standard Deviation
Percentage of Impairment
Baseline, Week 24; Baseline Week 52
ID
Title
Description
OG000
Methotrexate
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Secondary
Population Pharmacokinetics (PK): Peak Concentration at Steady State (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.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomole/Liter (nmol/L)
Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
ID
Title
Description
OG000
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000
Secondary
Population PK: Area Under the Concentration Versus Time Curve 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.
Posted
Geometric Mean
Geometric Coefficient of Variation
nanomole/Liter (nmol/L)
Week 0: 15 and 60 minutes postdose; Week 4: 2 to 4 hours post-dose; Week 8: 4 to 6 hours post-dose; Week 12; Week 24; Week 32; Pre-dose
ID
Title
Description
OG000
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000
Time Frame
Not provided
Description
All enrolled participants including those receiving rescue therapy, with events occurring after rescue accounted separately. Rescue therapy occurred at Week 24 or later, if determined to be nonresponders (lack of improvement of at least 20% in both tender joint count and swollen joint count).
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
Methotrexate
Methotrexate (MTX) administered orally once weekly with dose ranging from 10 to 20 milligram (mg) per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
20
210
115
210
EG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
12
159
81
159
EG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
17
215
129
215
EG003
Rescue Period
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52.
1
39
21
39
EG004
Methotrexate - Follow-up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
0
25
2
25
EG005
Baricitinib - Follow-up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
0
15
2
15
EG006
Baricitinib + MTX - Follow-up
No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug. Includes participants who were rescued to Baricitinib + MTX.
0
28
0
28
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG0031 events1 affected39 at risk
EG0040 events0 affected25 at risk
EG0050 events0 affected15 at risk
EG0060 events0 affected28 at risk
Coronary artery disease
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Cataract
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Chronic gastritis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Duodenal ulcer
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Enterocolitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Gastric ulcer haemorrhage
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Drowning
General disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Cholecystitis
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Acute hepatitis B
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Bronchitis haemophilus
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Campylobacter gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Escherichia sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Infectious colitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Lung infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Meningitis bacterial
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Pneumocystis jirovecii pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0011 events1 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Sepsis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Overdose
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Spinal compression fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Tibia fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Toxicity to various agents
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Lymphocyte count decreased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Cervix carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Gallbladder adenosquamous carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Malignant melanoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Migraine
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0011 events1 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Syncope
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Genital prolapse
Reproductive system and breast disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Chronic obstructive pulmonary disease
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Pneumothorax spontaneous
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Pulmonary fibrosis
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Constipation
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected210 at risk
EG0013 events2 affected159 at risk
EG0028 events7 affected215 at risk
EG0030 events0 affected39 at risk
EG0040 events0 affected25 at risk
EG0051 events1 affected15 at risk
EG0060 events0 affected28 at risk
Oedema peripheral
General disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Eczema asteatotic
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Miliaria
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Seborrhoeic dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Cardiomegaly
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Left ventricular hypertrophy
Cardiac disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Ear pruritus
Ear and labyrinth disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Hypothyroidism
Endocrine disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Scleritis
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Scleromalacia
Eye disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Abdominal discomfort
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Hepatitis E
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0013 events3 affected159 at risk
EG0025 events5 affected215 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00020 events17 affected210 at risk
EG00121 events16 affected159 at risk
EG00232 events21 affected215 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0006 events4 affected210 at risk
EG0012 events2 affected159 at risk
EG0029 events7 affected215 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG00015 events15 affected210 at risk
EG00114 events12 affected159 at risk
EG00219 events16 affected215 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Arthropod bite
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Joint injury
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Thermal burn
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Wrist fracture
Injury, poisoning and procedural complications
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0011 events1 affected159 at risk
EG00215 events13 affected215 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected210 at risk
EG0010 events0 affected159 at risk
EG0028 events7 affected215 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0015 events4 affected159 at risk
EG00211 events10 affected215 at risk
EG003
Blood creatinine increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Liver function test abnormal
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Lymphocyte count increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Hypercholesterolaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected210 at risk
EG0014 events4 affected159 at risk
EG0024 events4 affected215 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0013 events3 affected159 at risk
EG0026 events6 affected215 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0013 events3 affected159 at risk
EG00210 events9 affected215 at risk
EG003
Pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Polyuria
Renal and urinary disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Catarrh
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG00014 events13 affected210 at risk
EG0017 events5 affected159 at risk
EG0026 events6 affected215 at risk
EG003
Sinus congestion
Respiratory, thoracic and mediastinal disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Dermatitis
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Petechiae
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0010 events0 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Hypertension
Vascular disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected210 at risk
EG0012 events2 affected159 at risk
EG00213 events13 affected215 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0012 events2 affected159 at risk
EG0026 events6 affected215 at risk
EG003
Thrombocytosis
Blood and lymphatic system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0014 events4 affected159 at risk
EG0023 events3 affected215 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected210 at risk
EG0014 events3 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00015 events12 affected210 at risk
EG0013 events3 affected159 at risk
EG0026 events5 affected215 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0013 events3 affected159 at risk
EG0029 events8 affected215 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected210 at risk
EG0010 events0 affected159 at risk
EG0025 events5 affected215 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG00016 events13 affected210 at risk
EG0017 events7 affected159 at risk
EG00226 events20 affected215 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 18.0
Systematic Assessment
EG0006 events6 affected210 at risk
EG0015 events5 affected159 at risk
EG0028 events5 affected215 at risk
EG003
Fatigue
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0013 events3 affected159 at risk
EG0028 events8 affected215 at risk
EG003
Pyrexia
General disorders
MedDRA 18.0
Systematic Assessment
EG0005 events4 affected210 at risk
EG0011 events1 affected159 at risk
EG0026 events5 affected215 at risk
EG003
Hepatic function abnormal
Hepatobiliary disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0011 events1 affected159 at risk
EG0029 events8 affected215 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected210 at risk
EG0015 events5 affected159 at risk
EG00210 events9 affected215 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected210 at risk
EG00110 events10 affected159 at risk
EG0026 events6 affected215 at risk
EG003
Influenza
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected210 at risk
EG0017 events7 affected159 at risk
EG00211 events11 affected215 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected210 at risk
EG0011 events1 affected159 at risk
EG0023 events2 affected215 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0011 events1 affected159 at risk
EG0028 events7 affected215 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected210 at risk
EG0017 events6 affected159 at risk
EG00216 events14 affected215 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 18.0
Systematic Assessment
EG0001 events1 affected148 at risk
EG0010 events0 affected159 at risk
EG0028 events6 affected156 at risk
EG003
Weight increased
Investigations
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected210 at risk
EG0014 events4 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 18.0
Systematic Assessment
EG0002 events2 affected210 at risk
EG0012 events2 affected159 at risk
EG0028 events8 affected215 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0002 events1 affected210 at risk
EG0012 events2 affected159 at risk
EG0027 events7 affected215 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA 18.0
Systematic Assessment
EG0007 events7 affected210 at risk
EG0013 events3 affected159 at risk
EG0021 events1 affected215 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0006 events5 affected210 at risk
EG0011 events1 affected159 at risk
EG0024 events3 affected215 at risk
EG003
Headache
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0003 events3 affected210 at risk
EG0016 events5 affected159 at risk
EG0027 events6 affected215 at risk
EG003
Sciatica
Nervous system disorders
MedDRA 18.0
Systematic Assessment
EG0000 events0 affected210 at risk
EG0014 events4 affected159 at risk
EG0020 events0 affected215 at risk
EG003
Depression
Psychiatric disorders
MedDRA 18.0
Systematic Assessment
EG0004 events4 affected210 at risk
EG0016 events6 affected159 at risk
EG0022 events2 affected215 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 18.0
Systematic Assessment
EG0005 events5 affected210 at risk
EG0011 events1 affected159 at risk
EG0026 events6 affected215 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
D008727
Methotrexate
D005492
Folic Acid
Ancestor Terms
ID
Term
D000630
Aminopterin
D011622
Pterins
D011621
Pteridines
D006574
Heterocyclic Compounds, 2-Ring
D000072471
Heterocyclic Compounds, Fused-Ring
D006571
Heterocyclic Compounds
Browse Leaves
Not provided
Browse Branches
Not provided
49.9
± 13.4
156
BG003425
Male
BG00062
BG00138
BG00259
BG003159
20
BG00341
Asian
BG00060
BG00144
BG00261
BG003165
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
Black or African American
BG00010
BG0015
BG00210
BG00325
White
BG000128
BG00198
BG002123
BG003349
More than one race
BG0001
BG0012
BG0021
BG0034
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
33
BG003103
Austria
Title
Measurements
BG0001
BG0011
BG0021
BG0033
Belgium
Title
Measurements
BG0006
BG00110
BG00211
BG00327
Brazil
Title
Measurements
BG0008
BG0013
BG0029
BG00320
Canada
Title
Measurements
BG0005
BG0015
BG0027
BG00317
Germany
Title
Measurements
BG0005
BG0015
BG0024
BG00314
Greece
Title
Measurements
BG0000
BG0010
BG0021
BG0031
India
Title
Measurements
BG00018
BG00112
BG00217
BG00347
Italy
Title
Measurements
BG0008
BG0012
BG0024
BG00314
Japan
Title
Measurements
BG00036
BG00129
BG00239
BG003104
Mexico
Title
Measurements
BG00012
BG00114
BG00220
BG00346
Portugal
Title
Measurements
BG0001
BG0010
BG0022
BG0033
Russian Federation
Title
Measurements
BG00011
BG00113
BG00212
BG00336
South Africa
Title
Measurements
BG0007
BG0014
BG0029
BG00320
Korea, Republic of
Title
Measurements
BG0004
BG0011
BG0022
BG0037
Sweden
Title
Measurements
BG0003
BG0010
BG0021
BG0034
United Kingdom
Title
Measurements
BG0007
BG0013
BG0024
BG00314
United States
Title
Measurements
BG00037
BG00128
BG00239
BG003104
0.2
(0.1 to 1.0)
BG0030.2(0.1 to 0.8)
27.7
± 14.5
BG00326.9± 14.5
16.3
± 9.5
BG00316.3± 9.8
24.27
± 29.42
BG00323.44± 25.98
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Title
Measurements
OG00055.7
OG00173.0
OG00272.6
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Title
Measurements
OG000-0.73± 0.71
OG001-1.01± 0.74
OG002-0.92± 0.74
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Title
Measurements
OG000-2.01± 1.51
OG001-2.74± 1.39
OG002-2.82± 1.58
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000191
OG001152
OG002198
Title
Denominators
Categories
Title
Measurements
OG0000.64± 1.81
OG0010.43± 1.18
OG0020.32± 1.14
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Title
Measurements
OG00010.5
OG00122.0
OG00222.8
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Week 12
Title
Measurements
OG00032.9
OG00154.7
OG00260.0
Week 24
Title
Measurements
OG00043.3
OG00159.7
OG00263.3
Week 52
Title
Measurements
OG00037.6
OG00157.2
OG00261.9
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Week 12
Title
Measurements
OG00015.7
OG00130.8
OG00233.5
Week 24
Title
Measurements
OG00021.4
OG00142.1
OG00239.5
Week 52
Title
Measurements
OG00025.2
OG00142.1
OG00246.0
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000200
OG001157
OG002208
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-22.12± 16.12
OG001-28.20± 13.96
OG002-29.86± 14.05
Week 52
Title
Measurements
OG000-21.95± 18.07
OG001-28.94± 14.58
OG002-30.72± 14.87
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000203
OG001159
OG002209
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-2.20± 1.53
OG001-2.76± 1.45
OG002-3.06± 1.46
Week 52
Title
Measurements
OG000-2.32± 1.77
OG001-2.84± 1.57
OG002-3.22± 1.48
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
Week 12
Title
Measurements
OG0005.7
OG00113.8
OG00214.4
Week 24
Title
Measurements
OG0008.6
OG00118.9
OG00216.3
Week 52
Title
Measurements
OG00011.4
OG00117.0
OG00220.9
OG001
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000210
OG001159
OG002215
Title
Denominators
Categories
JSN Week 24
ParticipantsOG000191
ParticipantsOG001152
ParticipantsOG002198
Title
Measurements
OG0000.15± 0.94
OG0010.08± 0.44
OG0020.05± 0.44
JSN Week 52
ParticipantsOG000192
ParticipantsOG001154
ParticipantsOG002199
Title
Measurements
OG000
Bone Erosion Week 24
ParticipantsOG000191
ParticipantsOG001152
ParticipantsOG002198
Title
Measurements
OG000
Bone Erosion Week 52
ParticipantsOG000192
ParticipantsOG001154
ParticipantsOG002199
Title
Measurements
OG000
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000204
OG001159
OG002209
Title
Denominators
Categories
Title
Measurements
OG000-40.0(-55.0 to -30.0)
OG001-55.0(-60.0 to -40.0)
OG002-60.0(-80.0 to -50.0)
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000204
OG001159
OG002209
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-2.2± 2.7
OG001-3.0± 3.1
OG002-3.0± 2.8
Week 52
Title
Measurements
OG000-2.3± 2.8
OG001-2.9± 3.1
OG002-3.0± 2.9
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000204
OG001159
OG002209
Title
Denominators
Categories
Week 24
Title
Measurements
OG000-2.8± 2.5
OG001-3.9± 2.7
OG002-3.9± 2.6
Week 52
Title
Measurements
OG000-3.0± 2.8
OG001-3.9± 2.9
OG002-4.1± 2.7
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000202
OG001159
OG002207
Title
Denominators
Categories
MCS Week 24
Title
Measurements
OG0003.4± 10.8
OG0015.9± 11.7
OG0024.6± 11.6
MCS Week 52
Title
Measurements
OG0002.4± 10.9
OG0015.8± 11.9
OG0025.0± 11.5
PCS Week 24
Title
Measurements
OG0009.4± 9.2
OG00112.5± 9.1
OG00213.2± 9.6
PCS Week 52
Title
Measurements
OG0009.4± 10.1
OG00111.6± 9.6
OG00213.3± 9.8
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000202
OG001159
OG002207
Title
Denominators
Categories
Index Score (US Algorithm) Week 24
Title
Measurements
OG0000.142± 0.189
OG0010.197± 0.164
OG0020.194± 0.180
Index Score (US Algorithm) Week 52
Title
Measurements
OG0000.138± 0.203
OG0010.186± 0.177
OG0020.185± 0.186
Index Score (UK Algorithm) Week 24
Title
Measurements
OG0000.205± 0.274
OG0010.285± 0.241
OG0020.282± 0.255
Index Score (UK Algorithm) Week 52
Title
Measurements
OG0000.197± 0.294
OG0010.271± 0.258
OG0020.268± 0.266
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000202
OG001159
OG002207
Title
Denominators
Categories
Self-Perceived Health Week 24
Title
Measurements
OG00014.5± 28.3
OG00124.1± 26.0
OG00221.4± 31.4
Self-Perceived Health Week 52
Title
Measurements
OG00013.6± 30.1
OG00124.5± 28.7
OG00224.5± 30.6
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Units
Counts
Participants
OG000204
OG001159
OG002209
Title
Denominators
Categories
Week 24
Title
Measurements
OG0009.3± 11.2
OG00113.0± 10.8
OG00212.3± 11.5
Week 52
Title
Measurements
OG0009.1± 10.9
OG00111.3± 10.8
OG00212.6± 11.8
OG002
Baricitinib + MTX
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.