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A Study in Moderate to Severe Rheumatoid Arthritis (RA-BEAM)

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Adalimumab

Baricitinib

Methotrexate

Adalimumab Placebo

Baricitinib Placebo

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥6 milligram per Liter (mg/L)
Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response.
Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status

Exclusion Criteria:

Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease-modifying antirheumatic drugs (cDMARDs)
Are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry
Have received leflunomide in the 12 weeks prior to study entry
Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
Have ever received any biologic disease-modifying antirheumatic drugs (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 injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study
Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
Have any condition or contraindication for adalimumab that would preclude the participant from participating in this protocol
Have active fibromyalgia that 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 Sjögren's syndrome are not excluded)
Have a diagnosis of Felty's syndrome
Have had any major surgery within 8 weeks prior to 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 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, or 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)

Sites / Locations

Arizona Arthritis & Rheumatology Research
Sun Valley Arthritis Center, LTD
Valley Arthritis Care, LLC
University of Boards Regent
Valley Endocrine, Fresno
Desert Medical Advances
Pacific Arthritis Center
Inlande Rheumatology Clinical Trials
Boulder Medical Center
Clinical Research Center of CT/NY
New England Research Associates
Delaware Arthritis
Orthopedic Research Institute
Jeffrey Alper, M.D.
Sun Coast Clinical Research, Inc
Rheumatology Associates of Central Florida
Integral Rheumatology & Immunology Specialists
McIlwain Medical Group
Indiana University Health
Diagnostic Rheumatology and Research
Goldpoint Clinical Research LLC
West Michigan Rheumatology
University of Missouri
Dr. George Timothy Kelly
(AOA) Arthritis & Osteoporosis Associates
Bio Behavioral Health
Drug Trials of America
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Paramount Medical Research
Health Research Institute
Healthcare Research Consultant
Oregon Health and Science University
East Penn Rheumatology
Clinical Research Center of Reading, LLP
Carolina Rheumatology and Neurology Associates
Metroplex Clinical Research Center
Pioneer Research Solutions
Accurate Clinical Research
Arthritis & Osteoporosis Associates LLP
Accurate Clinical Research
Accurate Clinical Research
Center for Arthritis and Rheumatic Diseases, PC
The Seattle Arthritis Clinic
Vancouver Clinic
Rheumatology and Immunotherapy Center
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Ramon L. Ortega Colon
Office of Dr. Ramon Toro
Mindful Medical Research
Latin Clinical Trial Center
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

Placebo

Baricitinib

Adalimumab

Arm Description

Placebo administered orally once daily through Week 24 and placebo administered by subcutaneous (SC) injection every 2 weeks through Week 50. At Week 24, participants were given baricitinib 4 milligram (mg) orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.

Baricitinib 4 mg administered orally once daily through Week 52 and an adalimumab placebo SC injection every 2 weeks through Week 50. Starting at Week 16, nonresponder participants originally randomized to baricitinib continued to receive baricitinib 4 mg administered orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.

Adalimumab 40 mg administered by SC injection every 2 weeks through Week 50 and baricitinib placebo orally once daily through Week 52. Starting at Week 16, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily through Week 52. Participants continued to take background methotrexate (MTX) therapy throughout study.

Outcomes

Primary Outcome Measures

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 timepoint were deemed non-responders.

Secondary Outcome Measures

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. 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.

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

The HAQ-DI questionnaire assesses the participant's self-perception on the degree of difficulty (0 [without any difficulty], 1 [with some difficulty], 2 [with much difficulty], and 3 [unable to do]) when dressing and grooming, arising, eating, walking, hygiene, reaching, gripping, and performing other daily activities. Scores for each functional area were averaged to calculate the HAQ-DI score, which ranged from 0 (no disability) to 3 (worst disability). A decrease in HAQ-DI score indicated an improvement in the participant's condition.

Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)

Disease Activity Score (DAS) modified to include 28 joint count (DAS28) consisted of composite score of following variables: tender joint count (TJC28), swollen joint count (SJC28), C-reactive protein (CRP) (milligrams per liter), and Patient's Global Assessment of Disease Activity using visual analog scale (VAS) (participant global VAS). DAS28 was calculated using following formula: DAS28-CRP=0.56*square root (sqrt)(TJC28)+0.28*sqrt(SJC28)+0.36*natural log(CRP+1)+0.014*Patient's Global VAS+0.96. Scores ranged 1.0-9.4, where lower scores indicated less disease activity.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response

ACR50 and ACR70 Responder Index is a composite of clinical, laboratory, and functional measures in RA. ACR50 and ACR70 Responder is a participant who has at least 50% or 70% improvement, respectively, 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.

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.

Percentage of Participants Achieving 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.

Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission

The ACR/EULAR definitions of RA remission includes a Boolean-based definition. The Boolean-based definition of remission occurs when all 4 of the following criteria are met at the same visit: TJC28 ≤1, SJC28 ≤1, acute phase response using C-reactive protein (milligrams per deciliter) ≤1, Patient's Global Assessment of Disease Activity using VAS (cm) ≤1.

Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries

Participants recorded the duration of their morning joint stiffness (MJS) in hours and minutes into electronic diaries daily. If morning joint stiffness duration was longer than 12 hours (720 minutes), it was truncated to 720 minutes for statistical presentations and analyses. The average value across the 7 days preceding each visit was calculated. A decrease in duration of morning joint stiffness indicated an improvement in the participant's condition.

Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

Participants rated the severity of their morning joint stiffness by selecting a number from 0 to 10 that best described their overall level of morning joint stiffness from the time they woke up, where 0 represents "no joint stiffness" and 10 represents "joint stiffness as bad as you can imagine". Participants reported their severity daily in electronic diaries. The average value across the 7 days preceding each visit was calculated.

Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

Participants rated their tiredness by selecting a number from 0 to 10 that best described their worst tiredness during the last 24 hours, where 0 represents "no tiredness" and 10 represents "as bad as you can imagine". Participants reported their worst tiredness in electronic diaries. The average value across the 7 days preceding each visit is calculated.

Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries

Participants rated their joint pain by selecting a number from 0 to 10 that best described their worst joint pain during the last 24 hours, where 0 represents "no pain" and 10 represents "pain as bad as you can imagine". Participants reported their worst joint pain in daily electronic diaries. The average value across the 7 days preceding each visit was calculated.

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores

The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale is a brief 13-item, symptom-specific questionnaire that specifically assesses the participant's self-reported severity of fatigue and its impact upon daily activities and functioning. The FACIT-F uses a numeric rating scale of 0 ("Not at all") to 4 ("Very much") for each item to assess fatigue and its impact in the past 7 days. Total scores range from 0 to 52, with higher scores indicating less fatigue.

Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)

The SF-36 is a health-related survey that assesses participant's quality of life and consists of 36 questions covering 8 health domains: physical functioning, bodily pain, role limitations due to physical problems and emotional problems, general health, mental health, social functioning, vitality, and 2 component scores (mental [MCS] and physical [PCS]). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with higher scores indicating better health status or functioning.

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.

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.

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.

Change From Baseline in Joint Space Narrowing (JSN) 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).

Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib

Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

Full Information

NCT ID

NCT01710358

First Posted

October 17, 2012

Last Updated

September 9, 2019

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT01710358

Brief Title

A Study in Moderate to Severe Rheumatoid Arthritis

Acronym

RA-BEAM

Official Title

A Randomized, Double-Blind, Placebo- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Baricitinib in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate Therapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

October 2012 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to determine whether baricitinib is superior to placebo in the treatment of participants with moderately to severely active Rheumatoid Arthritis (RA) who have had an inadequate response to methotrexate (MTX) treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1307 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Arm Title

Baricitinib

Arm Type

Experimental

Arm Description

Arm Title

Adalimumab

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Baricitinib

Other Intervention Name(s)

LY 3009104

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Methotrexate

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Adalimumab Placebo

Intervention Description

Adalimumab placebo administered SC.

Intervention Type

Drug

Intervention Name(s)

Baricitinib Placebo

Intervention Description

Baricitinib placebo administered orally.

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)

Description

Time Frame

Week 12

Secondary Outcome Measure Information:

Title

Change From Baseline in the Modified Total Sharp Score (mTSS)

Description

Time Frame

Baseline, Week 24

Title

Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

Description

Time Frame

Baseline, Week 12

Title

Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)

Description

Time Frame

Baseline, Week 12

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response

Description

Time Frame

Week 12, Week 24, Week 52

Title

Change From Baseline in Clinical Disease Activity Index (CDAI) Score

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Percentage of Participants Achieving Simplified Disease Activity Index (SDAI) Score ≤3.3

Description

Time Frame

Week 12, Week 24, Week 52

Title

Percentage of Participants Achieving American College of Rheumatology European League Against Rheumatism (ACR/EULAR) Remission - Boolean Remission

Description

Time Frame

Week 12, Week 24, Week 52

Title

Median of Individual Participant Mean Duration of Morning Joint Stiffness in the Prior 7 Days as Collected in Electronic Diaries

Description

Time Frame

Week 12

Title

Mean Severity of Morning Joint Stiffness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

Description

Time Frame

Week 12

Title

Mean Worst Tiredness Numeric Rating Scale (NRS) in the Prior 7 Days as Collected in Electronic Diaries

Description

Time Frame

Week 12

Title

Mean Worst Joint Pain NRS in the Prior 7 Days as Collected in Electronic Diaries

Description

Time Frame

Week 12

Title

Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale Scores

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Change From Baseline in Mental Component Score (MCS), Physical Component Score (PCS) of the Medical Outcomes Study 36-Item Short Form Health Survey Version 2 Acute (SF-36v2 Acute)

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Change From Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores (Self-Perceived Health)

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Scores

Description

Time Frame

Baseline, Week 12, Week 24, Week 52

Title

Change From Baseline in Joint Space Narrowing (JSN) and Bone Erosion Scores

Description

Time Frame

Baseline, Week 24, Week 52

Title

Population Pharmacokinetics (PK): Peak Concentration at Steady State (Cmax,ss) of Baricitinib

Time Frame

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 12; Week 24; Week 32: Pre-dose

Title

Population PK: Area Under the Concentration Versus Time Curve at a Dosing Interval at Steady State (AUCtau,ss) of Baricitinib

Time Frame

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 12; Week 24; Week 32: Pre-dose

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a diagnosis of adult-onset Rheumatoid Arthritis (RA) as defined by the American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥6 milligram per Liter (mg/L) Have had regular use of methotrexate (MTX) for at least the 12 weeks prior to study entry at a dose that is considered acceptable to adequately assess clinical response. Have at least 1 joint erosion in hand, wrist, or foot joints based on radiographic interpretation by the central reader and be rheumatoid factor or anticyclic citrullinated peptide (anti-CCP) antibody positive; or have at least 3 joint erosions in hand, wrist, or foot joints based on radiographic interpretation by the central reader regardless of rheumatoid factor or anti-CCP antibody status Exclusion Criteria: Are currently receiving corticosteroids at doses >10 mg of prednisone per day (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization Are currently receiving concomitant treatment with MTX, hydroxychloroquine, and sulfasalazine or combination of any 3 conventional disease-modifying antirheumatic drugs (cDMARDs) Are currently receiving or have received cDMARDs (eg, gold salts, cyclosporine, azathioprine, or any other immunosuppressives) other than MTX, hydroxychloroquine (up to 400 mg/day), or sulfasalazine (up to 3000 mg/day) within 4 weeks prior to study entry Have received leflunomide in the 12 weeks prior to study entry Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry Have ever received any biologic disease-modifying antirheumatic drugs (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 injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require parenteral injection of corticosteroids during the study Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization Have any condition or contraindication for adalimumab that would preclude the participant from participating in this protocol Have active fibromyalgia that 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 Sjögren's syndrome are not excluded) Have a diagnosis of Felty's syndrome Have had any major surgery within 8 weeks prior to 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 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, or 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Arthritis & Rheumatology Research

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85304

Country

United States

Facility Name

Sun Valley Arthritis Center, LTD

City

Peoria

State/Province

Arizona

ZIP/Postal Code

85381

Country

United States

Facility Name

Valley Arthritis Care, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85023

Country

United States

Facility Name

University of Boards Regent

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

Valley Endocrine, Fresno

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Pacific Arthritis Center

City

Santa Maria

State/Province

California

ZIP/Postal Code

93454

Country

United States

Facility Name

Inlande Rheumatology Clinical Trials

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Boulder Medical Center

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80304

Country

United States

Facility Name

Clinical Research Center of CT/NY

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

New England Research Associates

City

Trumbull

State/Province

Connecticut

ZIP/Postal Code

06611

Country

United States

Facility Name

Delaware Arthritis

City

Lewes

State/Province

Delaware

ZIP/Postal Code

19958

Country

United States

Facility Name

Orthopedic Research Institute

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33472

Country

United States

Facility Name

Jeffrey Alper, M.D.

City

Naples

State/Province

Florida

ZIP/Postal Code

34102

Country

United States

Facility Name

Sun Coast Clinical Research, Inc

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Facility Name

Rheumatology Associates of Central Florida

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Integral Rheumatology & Immunology Specialists

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

McIlwain Medical Group

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Facility Name

Indiana University Health

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Diagnostic Rheumatology and Research

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46227

Country

United States

Facility Name

Goldpoint Clinical Research LLC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

West Michigan Rheumatology

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

University of Missouri

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Dr. George Timothy Kelly

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89128

Country

United States

Facility Name

(AOA) Arthritis & Osteoporosis Associates

City

Freehold

State/Province

New Jersey

ZIP/Postal Code

07728

Country

United States

Facility Name

Bio Behavioral Health

City

Toms River

State/Province

New Jersey

ZIP/Postal Code

08755

Country

United States

Facility Name

Drug Trials of America

City

Hartsdale

State/Province

New York

ZIP/Postal Code

10530

Country

United States

Facility Name

Asheville Rheumatology & Osteoporosis Research Assoc, PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Paramount Medical Research

City

Middleburg Heights

State/Province

Ohio

ZIP/Postal Code

44130

Country

United States

Facility Name

Health Research Institute

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Healthcare Research Consultant

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74135

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

East Penn Rheumatology

City

Bethlehem

State/Province

Pennsylvania

ZIP/Postal Code

18017

Country

United States

Facility Name

Clinical Research Center of Reading, LLP

City

Wyomissing

State/Province

Pennsylvania

ZIP/Postal Code

19610

Country

United States

Facility Name

Carolina Rheumatology and Neurology Associates

City

Myrtle Beach

State/Province

South Carolina

ZIP/Postal Code

29572

Country

United States

Facility Name

Metroplex Clinical Research Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Pioneer Research Solutions

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Facility Name

Accurate Clinical Research

City

Houston

State/Province

Texas

ZIP/Postal Code

77084

Country

United States

Facility Name

Arthritis & Osteoporosis Associates LLP

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79424

Country

United States

Facility Name

Accurate Clinical Research

City

Nassau Bay

State/Province

Texas

ZIP/Postal Code

77058

Country

United States

Facility Name

Accurate Clinical Research

City

Webster

State/Province

Texas

ZIP/Postal Code

77508

Country

United States

Facility Name

Center for Arthritis and Rheumatic Diseases, PC

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23320

Country

United States

Facility Name

The Seattle Arthritis Clinic

City

Seattle

State/Province

Washington

ZIP/Postal Code

98133

Country

United States

Facility Name

Vancouver Clinic

City

Vancouver

State/Province

Washington

ZIP/Postal Code

98664

Country

United States

Facility Name

Rheumatology and Immunotherapy Center

City

Franklin

State/Province

Wisconsin

ZIP/Postal Code

53132

Country

United States

Facility Name

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.

City

Bahia Blanca

ZIP/Postal Code

B8000HXM

Country

Argentina

Facility Name

City

Buenos Aires

ZIP/Postal Code

CBA 1419

Country

Argentina

Facility Name

City

Caba

ZIP/Postal Code

C1440AAD

Country

Argentina

Facility Name

City

Córdoba

ZIP/Postal Code

5000

Country

Argentina

Facility Name

City

Mar Del Plata

ZIP/Postal Code

B7600FZN

Country

Argentina

Facility Name

City

Quilmes

ZIP/Postal Code

B1878DVC

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

City

San Fernando

ZIP/Postal Code

1646

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

5400

Country

Argentina

Facility Name

City

San Miguel De Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Genk

ZIP/Postal Code

3600

Country

Belgium

Facility Name

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

City

Kelowna

State/Province

British Columbia

ZIP/Postal Code

V1Y3G8

Country

Canada

Facility Name

City

Victoria

State/Province

British Columbia

ZIP/Postal Code

V8V 3P9

Country

Canada

Facility Name

City

Kitchener

State/Province

Ontario

ZIP/Postal Code

N2M 5N6

Country

Canada

Facility Name

City

St. Catherines

State/Province

Ontario

ZIP/Postal Code

L2N 7E4

Country

Canada

Facility Name

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 3L9

Country

Canada

Facility Name

City

Trois-Rivieres

State/Province

Quebec

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Beijing

ZIP/Postal Code

100044

Country

China

Facility Name

City

Bengbu

ZIP/Postal Code

233004

Country

China

Facility Name

City

Changsha

ZIP/Postal Code

410011

Country

China

Facility Name

City

Guang Zhou

ZIP/Postal Code

510630

Country

China

Facility Name

City

Hefei

ZIP/Postal Code

230022

Country

China

Facility Name

City

Jinan

ZIP/Postal Code

250012

Country

China

Facility Name

City

Shanghai

ZIP/Postal Code

200052

Country

China

Facility Name

City

Wu Han

ZIP/Postal Code

430030

Country

China

Facility Name

City

Varazdin

ZIP/Postal Code

42000

Country

Croatia

Facility Name

City

Zagreb

ZIP/Postal Code

10 000

Country

Croatia

Facility Name

City

Brno

ZIP/Postal Code

61141

Country

Czechia

Facility Name

City

Bruntal

ZIP/Postal Code

79201

Country

Czechia

Facility Name

City

Hustopece

ZIP/Postal Code

693 01

Country

Czechia

Facility Name

City

Ostrava - Trebovice

ZIP/Postal Code

722 00

Country

Czechia

Facility Name

City

Ostrava

ZIP/Postal Code

702 00

Country

Czechia

Facility Name

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

City

Prague

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

City

Zlin

ZIP/Postal Code

760 01

Country

Czechia

Facility Name

City

Cahors Cedex 9

ZIP/Postal Code

46005

Country

France

Facility Name

City

Limoges

ZIP/Postal Code

87042

Country

France

Facility Name

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

City

Orleans

ZIP/Postal Code

45032

Country

France

Facility Name

City

Paris

ZIP/Postal Code

75679

Country

France

Facility Name

City

Poitiers

ZIP/Postal Code

86021

Country

France

Facility Name

City

Strasbourg

ZIP/Postal Code

67098

Country

France

Facility Name

City

Thionville

ZIP/Postal Code

57100

Country

France

Facility Name

City

Tours

ZIP/Postal Code

37044

Country

France

Facility Name

City

Gommern

ZIP/Postal Code

39245

Country

Germany

Facility Name

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

City

Athens

ZIP/Postal Code

11527

Country

Greece

Facility Name

City

Heraklion

ZIP/Postal Code

71110

Country

Greece

Facility Name

City

Larissa

ZIP/Postal Code

41221

Country

Greece

Facility Name

City

Marousi

ZIP/Postal Code

14561

Country

Greece

Facility Name

City

Budapest

ZIP/Postal Code

1023

Country

Hungary

Facility Name

City

Kiskunhalas

ZIP/Postal Code

6400

Country

Hungary

Facility Name

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

City

Szekesfehervar

ZIP/Postal Code

8000

Country

Hungary

Facility Name

City

Veszprem

ZIP/Postal Code

8200

Country

Hungary

Facility Name

City

Aichi

ZIP/Postal Code

450-0002

Country

Japan

Facility Name

City

Chiba

ZIP/Postal Code

284-0003

Country

Japan

Facility Name

City

Fukuoka

ZIP/Postal Code

814-0002

Country

Japan

Facility Name

City

Hiroshima

ZIP/Postal Code

730-0017

Country

Japan

Facility Name

City

Hokkaido

ZIP/Postal Code

063-0811

Country

Japan

Facility Name

City

Hyogo

ZIP/Postal Code

665-0827

Country

Japan

Facility Name

City

Ibaragi

ZIP/Postal Code

316-0015

Country

Japan

Facility Name

City

Ibaraki

ZIP/Postal Code

305-8576

Country

Japan

Facility Name

City

Iwate

ZIP/Postal Code

020-0034

Country

Japan

Facility Name

City

Japan

ZIP/Postal Code

275-8580

Country

Japan

Facility Name

City

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

City

Kagoshima

ZIP/Postal Code

211-0063

Country

Japan

Facility Name

City

Kanagawa

ZIP/Postal Code

224-0041

Country

Japan

Facility Name

City

Kumamoto

ZIP/Postal Code

862-8655

Country

Japan

Facility Name

City

Mie

ZIP/Postal Code

510-0016

Country

Japan

Facility Name

City

Nagano

ZIP/Postal Code

380-8582

Country

Japan

Facility Name

City

Nagasaki

ZIP/Postal Code

850-0832

Country

Japan

Facility Name

City

Niigata

ZIP/Postal Code

957-0054

Country

Japan

Facility Name

City

Oita

ZIP/Postal Code

870-0823

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

700-0013

Country

Japan

Facility Name

City

Okinawa

ZIP/Postal Code

901-0243

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-0011

Country

Japan

Facility Name

City

Saga

ZIP/Postal Code

843-0393

Country

Japan

Facility Name

City

Saitama

ZIP/Postal Code

333-0833

Country

Japan

Facility Name

City

Shizuoka

ZIP/Postal Code

420-0821

Country

Japan

Facility Name

City

Tochigi

ZIP/Postal Code

329- 0498

Country

Japan

Facility Name

City

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

Facility Name

City

Toyama

ZIP/Postal Code

933-0874

Country

Japan

Facility Name

City

Yamaguchi

ZIP/Postal Code

745-0824

Country

Japan

Facility Name

City

Daegu

ZIP/Postal Code

700-712

Country

Korea, Republic of

Facility Name

City

Daejeon

ZIP/Postal Code

301-721

Country

Korea, Republic of

Facility Name

City

Gwangju

ZIP/Postal Code

510-757

Country

Korea, Republic of

Facility Name

City

Incheon

ZIP/Postal Code

400-711

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

130-702

Country

Korea, Republic of

Facility Name

City

Suwon-Si

ZIP/Postal Code

443-721

Country

Korea, Republic of

Facility Name

City

Liepaja

ZIP/Postal Code

LV-3401

Country

Latvia

Facility Name

City

Riga

ZIP/Postal Code

LV-1002

Country

Latvia

Facility Name

City

Valmiera

ZIP/Postal Code

LV-4201

Country

Latvia

Facility Name

City

Kaunas

ZIP/Postal Code

LT-50128

Country

Lithuania

Facility Name

City

Klaipeda

ZIP/Postal Code

LT-92288

Country

Lithuania

Facility Name

City

Siauliai

ZIP/Postal Code

76231

Country

Lithuania

Facility Name

City

Guadalajara

ZIP/Postal Code

44690

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21200

Country

Mexico

Facility Name

City

Mexico

ZIP/Postal Code

06600

Country

Mexico

Facility Name

City

San Luis Potosi

ZIP/Postal Code

78213

Country

Mexico

Facility Name

City

Tijuana

ZIP/Postal Code

22010

Country

Mexico

Facility Name

City

Bydgoszcz

ZIP/Postal Code

85-168

Country

Poland

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

City

Katowice

ZIP/Postal Code

40-084

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-242

Country

Poland

Facility Name

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

City

Warszawa

ZIP/Postal Code

02-653

Country

Poland

Facility Name

City

Lisbon

ZIP/Postal Code

1050

Country

Portugal

Facility Name

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Ramon L. Ortega Colon

City

Carolina

ZIP/Postal Code

00983

Country

Puerto Rico

Facility Name

Office of Dr. Ramon Toro

City

San German

ZIP/Postal Code

00683

Country

Puerto Rico

Facility Name

Mindful Medical Research

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Latin Clinical Trial Center

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Bucharest

ZIP/Postal Code

10584

Country

Romania

Facility Name

City

Cluj-Napoca

ZIP/Postal Code

400006

Country

Romania

Facility Name

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

City

Lasi

ZIP/Postal Code

700661

Country

Romania

Facility Name

City

Oradea

ZIP/Postal Code

410028

Country

Romania

Facility Name

City

Targu Mures

ZIP/Postal Code

540136

Country

Romania

Facility Name

City

Korolev

ZIP/Postal Code

141060

Country

Russian Federation

Facility Name

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

City

Saint Petersburg

ZIP/Postal Code

194291

Country

Russian Federation

Facility Name

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

City

Ulyanovsk

ZIP/Postal Code

432063

Country

Russian Federation

Facility Name

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

Facility Name

City

Bratislava

ZIP/Postal Code

84231

Country

Slovakia

Facility Name

City

Partizanske

ZIP/Postal Code

95801

Country

Slovakia

Facility Name

City

Spisska Nova Ves

ZIP/Postal Code

052 01

Country

Slovakia

Facility Name

City

Topolcany

ZIP/Postal Code

95501

Country

Slovakia

Facility Name

City

Ljubljana

ZIP/Postal Code

1000

Country

Slovenia

Facility Name

City

Maribor

ZIP/Postal Code

2000

Country

Slovenia

Facility Name

City

Durban

ZIP/Postal Code

4001

Country

South Africa

Facility Name

City

Greenacres

ZIP/Postal Code

6057

Country

South Africa

Facility Name

City

Pinelands

ZIP/Postal Code

7405

Country

South Africa

Facility Name

City

Stellenbosch

ZIP/Postal Code

7600

Country

South Africa

Facility Name

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

City

Hospitalet De Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

City

Sabadell

ZIP/Postal Code

08208

Country

Spain

Facility Name

City

Santander

ZIP/Postal Code

39008

Country

Spain

Facility Name

City

Sevilla

ZIP/Postal Code

41010

Country

Spain

Facility Name

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

City

Villajoyosa

ZIP/Postal Code

03570

Country

Spain

Facility Name

City

Fribourg

ZIP/Postal Code

1708

Country

Switzerland

Facility Name

City

Kaohsiung City

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

City

Neihu Taipei

ZIP/Postal Code

114

Country

Taiwan

Facility Name

City

Taichung City

ZIP/Postal Code

40201

Country

Taiwan

Facility Name

City

Taichung

ZIP/Postal Code

404

Country

Taiwan

Facility Name

City

Taipei

ZIP/Postal Code

10630

Country

Taiwan

Facility Name

City

Yongkang City

ZIP/Postal Code

71004

Country

Taiwan

Facility Name

City

London

State/Province

England

ZIP/Postal Code

SE1 9RT

Country

United Kingdom

Facility Name

City

London

State/Province

Greater London

ZIP/Postal Code

E11 1NR

Country

United Kingdom

Facility Name

City

Basingstoke

State/Province

Hampshire

ZIP/Postal Code

RG24 9NA

Country

United Kingdom

Facility Name

City

Southampton

State/Province

Hants

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

City

Aberdeen

State/Province

Scotland

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

City

North Shields

State/Province

Tyneside

ZIP/Postal Code

NE29 8NH

Country

United Kingdom

Facility Name

City

Bradford

State/Province

West Yorkshire

ZIP/Postal Code

BD5 0NA

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan 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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

34706874

Citation

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.

Results Reference

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PubMed Identifier

34526397

Citation

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.

Results Reference

derived

PubMed Identifier

32414425

Citation

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. Erratum In: Arthritis Res Ther. 2020 Jul 2;22(1):166.

Results Reference

derived

PubMed Identifier

31239736

Citation

Schlueter M, Finn E, Diaz S, Dilla T, Inciarte-Mundo J, Fakhouri W. Cost-effectiveness analysis of baricitinib versus adalimumab for the treatment of moderate-to-severe rheumatoid arthritis in Spain. Clinicoecon Outcomes Res. 2019 Jun 6;11:395-403. doi: 10.2147/CEOR.S201621. eCollection 2019.

Results Reference

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PubMed Identifier

31228100

Citation

Michaud K, Pope JE, Emery P, Zhu B, Gaich CL, DeLozier AM, Zhang X, Dickson CL, Smolen JS. Relative Impact of Pain and Fatigue on Work Productivity in Patients with Rheumatoid Arthritis from the RA-BEAM Baricitinib Trial. Rheumatol Ther. 2019 Sep;6(3):409-419. doi: 10.1007/s40744-019-0164-4. Epub 2019 Jun 21.

Results Reference

derived

PubMed Identifier

31040122

Citation

Tanaka Y, Fautrel B, Keystone EC, Ortmann RA, Xie L, Zhu B, Issa M, Patel H, Gaich CL, de Bono S, Rooney TP, Taylor PC. Clinical outcomes in patients switched from adalimumab to baricitinib due to non-response and/or study design: phase III data in patients with rheumatoid arthritis. Ann Rheum Dis. 2019 Jul;78(7):890-898. doi: 10.1136/annrheumdis-2018-214529. Epub 2019 Apr 30.

Results Reference

derived

PubMed Identifier

30902094

Citation

Bingham CO 3rd, Gaich CL, DeLozier AM, Engstrom KD, Naegeli AN, de Bono S, Banerjee P, Taylor PC. Use of daily electronic patient-reported outcome (PRO) diaries in randomized controlled trials for rheumatoid arthritis: rationale and implementation. Trials. 2019 Mar 22;20(1):182. doi: 10.1186/s13063-019-3272-0. Erratum In: Trials. 2019 Jun 4;20(1):322.

Results Reference

derived

PubMed Identifier

30842122

Citation

Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.

Results Reference

derived

PubMed Identifier

30219772

Citation

Smolen JS, Genovese MC, Takeuchi T, Hyslop DL, Macias WL, Rooney T, Chen L, Dickson CL, Riddle Camp J, Cardillo TE, Ishii T, Winthrop KL. Safety Profile of Baricitinib in Patients with Active Rheumatoid Arthritis with over 2 Years Median Time in Treatment. J Rheumatol. 2019 Jan;46(1):7-18. doi: 10.3899/jrheum.171361. Epub 2018 Sep 15. Erratum In: J Rheumatol. 2019 Dec;46(12):1648-1649.

Results Reference

derived

PubMed Identifier

30058112

Citation

Tanaka Y, McInnes IB, Taylor PC, Byers NL, Chen L, de Bono S, Issa M, Macias WL, Rogai V, Rooney TP, Schlichting DE, Zuckerman SH, Emery P. Characterization and Changes of Lymphocyte Subsets in Baricitinib-Treated Patients With Rheumatoid Arthritis: An Integrated Analysis. Arthritis Rheumatol. 2018 Dec;70(12):1923-1932. doi: 10.1002/art.40680. Epub 2018 Oct 22.

Results Reference

derived

PubMed Identifier

29680881

Citation

Wells AF, Greenwald M, Bradley JD, Alam J, Arora V, Kartman CE. Baricitinib in Patients with Rheumatoid Arthritis and an Inadequate Response to Conventional Disease-Modifying Antirheumatic Drugs in United States and Rest of World: A Subset Analysis. Rheumatol Ther. 2018 Jun;5(1):43-55. doi: 10.1007/s40744-018-0110-x. Epub 2018 Apr 21.

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PubMed Identifier

29463520

Citation

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.

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PubMed Identifier

28798049

Citation

Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, Zamora JV, Cobos JAC, Rooney T, Bono S, Arora V, Linetzky B, Weinblatt ME. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017 Nov;76(11):1853-1861. doi: 10.1136/annrheumdis-2017-211259. Epub 2017 Aug 10.

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PubMed Identifier

28199814

Citation

Taylor PC, Keystone EC, van der Heijde D, Weinblatt ME, Del Carmen Morales L, Reyes Gonzaga J, Yakushin S, Ishii T, Emoto K, Beattie S, Arora V, Gaich C, Rooney T, Schlichting D, Macias WL, de Bono S, Tanaka Y. Baricitinib versus Placebo or Adalimumab in Rheumatoid Arthritis. N Engl J Med. 2017 Feb 16;376(7):652-662. doi: 10.1056/NEJMoa1608345.

Results Reference

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Learn more about this trial

A Study in Moderate to Severe Rheumatoid Arthritis

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