A Study in Moderate to Severe Rheumatoid Arthritis
RA-BEAM
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
2 other identifiers
interventional
1,307
27 countries
211
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.
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 Oct 2012
Typical duration for phase_3 rheumatoid-arthritis
211 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 17, 2012
CompletedFirst Posted
Study publicly available on registry
October 19, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2015
CompletedResults Posted
Study results publicly available
August 15, 2017
CompletedSeptember 18, 2019
September 1, 2019
2.4 years
October 17, 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 timepoint were deemed non-responders.
Week 12
Secondary Outcomes (19)
Change From Baseline in the Modified Total Sharp Score (mTSS)
Baseline, Week 24
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
Baseline, Week 12
Change From Baseline in the Disease Activity Score Based on a 28-Joint Count and High-sensitivity C-reactive Protein (DAS28-hsCRP)
Baseline, Week 12
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) and 70% (ACR70) Response
Week 12, Week 24, Week 52
Change From Baseline in Clinical Disease Activity Index (CDAI) Score
Baseline, Week 12, Week 24, Week 52
- +14 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo 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
EXPERIMENTALBaricitinib 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
ACTIVE COMPARATORAdalimumab 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (213)
Arizona Arthritis & Rheumatology Research
Glendale, Arizona, 85304, United States
Sun Valley Arthritis Center, LTD
Peoria, Arizona, 85381, United States
Valley Arthritis Care, LLC
Phoenix, Arizona, 85023, United States
University of Boards Regent
Tucson, Arizona, 85724, United States
Valley Endocrine, Fresno
Fresno, California, 93720, United States
Desert Medical Advances
Palm Desert, California, 92260, United States
Pacific Arthritis Center
Santa Maria, California, 93454, United States
Inlande Rheumatology Clinical Trials
Upland, California, 91786, United States
Boulder Medical Center
Boulder, Colorado, 80304, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, 06810, United States
New England Research Associates
Trumbull, Connecticut, 06611, United States
Delaware Arthritis
Lewes, Delaware, 19958, United States
Orthopedic Research Institute
Boynton Beach, Florida, 33472, United States
Jeffrey Alper, M.D.
Naples, Florida, 34102, United States
Sun Coast Clinical Research, Inc
New Port Richey, Florida, 34652, United States
Rheumatology Associates of Central Florida
Orlando, Florida, 32806, United States
Integral Rheumatology & Immunology Specialists
Plantation, Florida, 33324, United States
McIlwain Medical Group
Tampa, Florida, 33613, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Diagnostic Rheumatology and Research
Indianapolis, Indiana, 46227, United States
Goldpoint Clinical Research LLC
Indianapolis, Indiana, 46260, United States
West Michigan Rheumatology
Grand Rapids, Michigan, 49546, United States
University of Missouri
Columbia, Missouri, 65212, United States
Dr. George Timothy Kelly
Las Vegas, Nevada, 89128, United States
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, 07728, United States
Bio Behavioral Health
Toms River, New Jersey, 08755, United States
Drug Trials of America
Hartsdale, New York, 10530, United States
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Asheville, North Carolina, 28803, United States
Paramount Medical Research
Middleburg Heights, Ohio, 44130, United States
Health Research Institute
Oklahoma City, Oklahoma, 73103, United States
Healthcare Research Consultant
Tulsa, Oklahoma, 74135, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
East Penn Rheumatology
Bethlehem, Pennsylvania, 18017, United States
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, 19610, United States
Carolina Rheumatology and Neurology Associates
Myrtle Beach, South Carolina, 29572, United States
Metroplex Clinical Research Center
Dallas, Texas, 75231, United States
Pioneer Research Solutions
Houston, Texas, 77008, United States
Accurate Clinical Research
Houston, Texas, 77084, United States
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, 79424, United States
Accurate Clinical Research
Nassau Bay, Texas, 77058, United States
Accurate Clinical Research
Webster, Texas, 77508, United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, 23320, United States
The Seattle Arthritis Clinic
Seattle, Washington, 98133, United States
Vancouver Clinic
Vancouver, Washington, 98664, United States
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, 53132, United States
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Bahía Blanca, B8000HXM, Argentina
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Buenos Aires, CBA 1419, Argentina
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Caba, C1440AAD, Argentina
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Córdoba, 5000, Argentina
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Mar del Plata, B7600FZN, Argentina
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Quilmes, B1878DVC, 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, T4000AXL, Argentina
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Brussels, 1200, Belgium
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Genk, 3600, Belgium
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Merksem, 2170, Belgium
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Mons, 7000, Belgium
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Kelowna, British Columbia, V1Y3G8, Canada
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Victoria, British Columbia, V8V 3P9, Canada
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Kitchener, Ontario, N2M 5N6, Canada
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Saint Catherines, Ontario, L2N 7E4, Canada
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Toronto, Ontario, M5T 3L9, Canada
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Trois-Rivières, Quebec, G8Z 1Y2, Canada
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Beijing, 100044, China
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Bengbu, 233004, China
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Changsha, 410011, China
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Guangzhou, 510630, China
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Hefei, 230022, China
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Jinan, 250012, China
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Shanghai, 200052, China
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Wuhan, 430030, China
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Varaždin, 42000, Croatia
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Zagreb, 10 000, Croatia
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Brno, 61141, Czechia
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Bruntál, 79201, Czechia
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Hustopeče, 693 01, Czechia
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Ostrava, 702 00, Czechia
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Ostrava - Trebovice, 722 00, Czechia
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Pardubice, 530 02, Czechia
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Prague, 128 50, Czechia
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Uherské Hradiště, 686 01, Czechia
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Zlín, 760 01, Czechia
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Cahors, 46005, France
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Limoges, 87042, France
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Montpellier, 34295, France
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Nantes, 44093, France
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Orléans, 45032, France
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Paris, 75679, France
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Poitiers, 86021, France
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Strasbourg, 67098, France
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Thionville, 57100, France
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Tours, 37044, France
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Cologne, 50937, Germany
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Gommern, 39245, Germany
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Herne, 44649, Germany
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Würzburg, 97080, Germany
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Athens, 11527, Greece
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Heraklion, 71110, Greece
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Larissa, 41221, Greece
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Marousi, 14561, Greece
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Budapest, 1023, Hungary
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Kiskunhalas, 6400, Hungary
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Nyíregyháza, 4400, Hungary
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Székesfehérvár, 8000, Hungary
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Veszprém, 8200, Hungary
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Aichi, 450-0002, Japan
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Chiba, 284-0003, Japan
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Fukuoka, 814-0002, Japan
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Hiroshima, 730-0017, Japan
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Hokkaido, 063-0811, Japan
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Hyōgo, 665-0827, Japan
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Ibaraki, 305-8576, 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, 211-0063, Japan
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Kanagawa, 224-0041, Japan
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Kumamoto, 862-8655, Japan
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Mie, 510-0016, Japan
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Nagano, 380-8582, Japan
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Nagasaki, 850-0832, Japan
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Niigata, 957-0054, Japan
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Numakunai, 020-0034, Japan
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Okayama, 700-0013, Japan
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Okinawa, 901-0243, Japan
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Osaka, 545-0011, Japan
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Ōita, 870-0823, Japan
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Saga, 843-0393, Japan
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Saitama, 333-0833, Japan
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Shizuoka, 420-0821, Japan
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Tochigi, 329- 0498, Japan
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Tokyo, 160-8582, Japan
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Toyama, 933-0874, Japan
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Yamaguchi, 745-0824, Japan
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Liepāja, LV-3401, Latvia
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Riga, LV-1002, Latvia
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Valmiera, LV-4201, Latvia
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Kaunas, LT-50128, Lithuania
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Klaipėda, LT-92288, Lithuania
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Šiauliai, 76231, Lithuania
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Guadalajara, 44690, Mexico
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Mexicali, 21200, Mexico
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Mérida, 97070, Mexico
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México, 06600, Mexico
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San Luis Potosí City, 78213, Mexico
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Tijuana, 22010, Mexico
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Bydgoszcz, 85-168, Poland
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Elblag, 82-300, Poland
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Gdansk, 80-546, Poland
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Katowice, 40-084, Poland
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Lodz, 90-242, Poland
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Nadarzyn, 05-830, Poland
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Warsaw, 02-653, Poland
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Lisbon, 1050, Portugal
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Porto, 4200-319, Portugal
Ramon L. Ortega Colon
Carolina, 00983, Puerto Rico
Office of Dr. Ramon Toro
San Germán, 00683, Puerto Rico
Mindful Medical Research
San Juan, 00918, Puerto Rico
Latin Clinical Trial Center
Santurce, 00909, Puerto Rico
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Bucharest, 10584, Romania
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Cluj-Napoca, 400006, Romania
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Constanța, 900591, Romania
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Lasi, 700661, Romania
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Oradea, 410028, Romania
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Târgu Mureş, 540136, Romania
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Korolyov, 141060, Russia
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Moscow, 115522, Russia
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Ryazan, 390026, Russia
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Saint Petersburg, 194291, Russia
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Saratov, 410053, Russia
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Ulyanovsk, 432063, Russia
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Yaroslavl, 150003, Russia
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Bratislava, 84231, Slovakia
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Partizánske, 95801, Slovakia
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Spišská Nová Ves, 052 01, Slovakia
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Topoľčany, 95501, Slovakia
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Ljubljana, 1000, Slovenia
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Maribor, 2000, Slovenia
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Durban, 4001, South Africa
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Greenacres, 6057, South Africa
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Pinelands, 7405, South Africa
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Stellenbosch, 7600, South Africa
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Daegu, 700-712, South Korea
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Daejeon, 301-721, South Korea
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Gwangju, 510-757, South Korea
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Incheon, 400-711, South Korea
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Seoul, 130-702, South Korea
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Suwon, 443-721, South Korea
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Barcelona, 08025, Spain
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Bilbao, 48013, Spain
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L'Hospitalet de Llobregat, 08907, Spain
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Madrid, 28040, Spain
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Sabadell, 08208, Spain
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Santander, 39008, Spain
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Seville, 41010, Spain
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Valencia, 46026, Spain
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Villajoyosa, 03570, Spain
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Fribourg, 1708, Switzerland
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Kaohsiung City, 83301, Taiwan
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Neihu Taipei, 114, Taiwan
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Taichung, 40201, Taiwan
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Taichung, 404, Taiwan
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Taipei, 10630, Taiwan
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Yongkang District, 71004, Taiwan
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London, England, SE1 9RT, United Kingdom
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London, Greater London, E11 1NR, 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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Aberdeen, Scotland, AB25 2ZN, United Kingdom
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North Shields, Tyneside, NE29 8NH, United Kingdom
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Bradford, West Yorkshire, BD5 0NA, United Kingdom
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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, 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: 32414425DERIVEDSchlueter 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.
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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 17, 2012
First Posted
October 19, 2012
Study Start
October 1, 2012
Primary Completion
March 1, 2015
Study Completion
September 1, 2015
Last Updated
September 18, 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.