A Study in Participants With Moderate to Severe Rheumatoid Arthritis
RA-BEGIN
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
2 other identifiers
interventional
588
19 countries
154
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Nov 2012
Typical duration for phase_3 rheumatoid-arthritis
154 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 18, 2012
CompletedFirst Posted
Study publicly available on registry
October 22, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
August 15, 2017
CompletedSeptember 19, 2019
September 1, 2019
2.3 years
October 18, 2012
March 10, 2017
September 9, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 (21)
Percentage of Participants Achieving American College of Rheumatology 20% Improvement (ACR20)
Week 52
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
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)
Baseline, Week 24
Change From Baseline in the Modified Total Sharp Score (mTSS)
Baseline, Week 24
Percentage of Participants Who Achieved a Simplified Disease Activity Index (SDAI) Score ≤3.3
Week 24
- +16 more secondary outcomes
Study Arms (3)
Baricitinib + MTX
EXPERIMENTALBaricitinib 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.
Baricitinib
EXPERIMENTALBaricitinib 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.
MTX
ACTIVE COMPARATORMTX 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- +13 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (154)
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Glendale, Arizona, 85304, United States
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Mesa, Arizona, 85202, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85037, United States
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El Cajon, California, 92020, United States
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Lakewood, California, 90712, United States
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Palm Desert, California, 92260, United States
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Tustin, California, 92780, United States
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Upland, California, 91786, United States
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Boulder, Colorado, 80304, United States
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Trumbull, Connecticut, 06611, United States
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Lewes, Delaware, 19958, United States
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Boynton Beach, Florida, 33472, United States
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Naples, Florida, 34102, United States
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Orlando, Florida, 32806, United States
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Palm Harbor, Florida, 34684, United States
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Plantation, Florida, 33324, United States
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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 Germán, 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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Malmo, 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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North Shields, Tyneside, NE29 8NH, United Kingdom
Related Publications (10)
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.
PMID: 37015757DERIVEDTaylor 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.
PMID: 35264432DERIVEDTaylor 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.
PMID: 34706874DERIVEDvan 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.
PMID: 34526397DERIVEDEmery 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.
PMID: 32414425DERIVEDFleischmann 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.
PMID: 31233281DERIVEDSmolen 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.
PMID: 30219772DERIVEDTaylor 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.
PMID: 29463520DERIVEDSchiff 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.
PMID: 28923098DERIVEDFleischmann 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.
PMID: 27723271DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2012
First Posted
October 22, 2012
Study Start
November 1, 2012
Primary Completion
February 1, 2015
Study Completion
August 1, 2015
Last Updated
September 19, 2019
Results First Posted
August 15, 2017
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, 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.
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.