Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
1307 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-10-31
Study Completion Date
2015-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Rheumatoid Arthritis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Placebo
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.
Group Type
PLACEBO_COMPARATOR
Methotrexate
Intervention Type
DRUG
Administered orally
Adalimumab Placebo
Intervention Type
DRUG
Adalimumab placebo administered SC.
Baricitinib Placebo
Intervention Type
DRUG
Baricitinib placebo administered orally.
Baricitinib
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.
Group Type
EXPERIMENTAL
Baricitinib
Intervention Type
DRUG
Administered orally
Methotrexate
Intervention Type
DRUG
Administered orally
Adalimumab Placebo
Intervention Type
DRUG
Adalimumab placebo administered SC.
Adalimumab
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.
Group Type
ACTIVE_COMPARATOR
Adalimumab
Intervention Type
DRUG
Administered SC
Methotrexate
Intervention Type
DRUG
Administered orally
Baricitinib Placebo
Intervention Type
DRUG
Baricitinib placebo administered orally.
Interventions
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Adalimumab
Administered SC
Intervention Type
DRUG
Baricitinib
Administered orally
Intervention Type
DRUG
Methotrexate
Administered orally
Intervention Type
DRUG
Adalimumab Placebo
Adalimumab placebo administered SC.
Intervention Type
DRUG
Baricitinib Placebo
Baricitinib placebo administered orally.
Intervention Type
DRUG
Other Intervention Names
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LY 3009104
Eligibility Criteria
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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
* 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)
* 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)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Research
Glendale, Arizona, United States
Site Status
Sun Valley Arthritis Center, LTD
Peoria, Arizona, United States
Site Status
Valley Arthritis Care, LLC
Phoenix, Arizona, United States
Site Status
University of Boards Regent
Tucson, Arizona, United States
Site Status
Valley Endocrine, Fresno
Fresno, California, United States
Site Status
Desert Medical Advances
Palm Desert, California, United States
Site Status
Pacific Arthritis Center
Santa Maria, California, United States
Site Status
Inlande Rheumatology Clinical Trials
Upland, California, United States
Site Status
Boulder Medical Center
Boulder, Colorado, United States
Site Status
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Site Status
New England Research Associates
Trumbull, Connecticut, United States
Site Status
Delaware Arthritis
Lewes, Delaware, United States
Site Status
Orthopedic Research Institute
Boynton Beach, Florida, United States
Site Status
Jeffrey Alper, M.D.
Naples, Florida, United States
Site Status
Sun Coast Clinical Research, Inc
New Port Richey, Florida, United States
Site Status
Rheumatology Associates of Central Florida
Orlando, Florida, United States
Site Status
Integral Rheumatology & Immunology Specialists
Plantation, Florida, United States
Site Status
McIlwain Medical Group
Tampa, Florida, United States
Site Status
Indiana University Health
Indianapolis, Indiana, United States
Site Status
Diagnostic Rheumatology and Research
Indianapolis, Indiana, United States
Site Status
Goldpoint Clinical Research LLC
Indianapolis, Indiana, United States
Site Status
West Michigan Rheumatology
Grand Rapids, Michigan, United States
Site Status
University of Missouri
Columbia, Missouri, United States
Site Status
Dr. George Timothy Kelly
Las Vegas, Nevada, United States
Site Status
(AOA) Arthritis & Osteoporosis Associates
Freehold, New Jersey, United States
Site Status
Bio Behavioral Health
Toms River, New Jersey, United States
Site Status
Drug Trials of America
Hartsdale, New York, United States
Site Status
Asheville Rheumatology & Osteoporosis Research Assoc, PA
Asheville, North Carolina, United States
Site Status
Paramount Medical Research
Middleburg Heights, Ohio, United States
Site Status
Health Research Institute
Oklahoma City, Oklahoma, United States
Site Status
Healthcare Research Consultant
Tulsa, Oklahoma, United States
Site Status
Oregon Health and Science University
Portland, Oregon, United States
Site Status
East Penn Rheumatology
Bethlehem, Pennsylvania, United States
Site Status
Clinical Research Center of Reading, LLP
Wyomissing, Pennsylvania, United States
Site Status
Carolina Rheumatology and Neurology Associates
Myrtle Beach, South Carolina, United States
Site Status
Metroplex Clinical Research Center
Dallas, Texas, United States
Site Status
Pioneer Research Solutions
Houston, Texas, United States
Site Status
Accurate Clinical Research
Houston, Texas, United States
Site Status
Arthritis & Osteoporosis Associates LLP
Lubbock, Texas, United States
Site Status
Accurate Clinical Research
Nassau Bay, Texas, United States
Site Status
Accurate Clinical Research
Webster, Texas, United States
Site Status
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake, Virginia, United States
Site Status
The Seattle Arthritis Clinic
Seattle, Washington, United States
Site Status
Vancouver Clinic
Vancouver, Washington, United States
Site Status
Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States
Site Status
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Bahía Blanca, , Argentina
Site Status
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Buenos Aires, , Argentina
Site Status
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Caba, , Argentina
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Córdoba, , Argentina
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Mar del Plata, , Argentina
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Quilmes, , Argentina
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Rosario, , Argentina
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San Fernando, , Argentina
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San Juan, , Argentina
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San Miguel de Tucumán, , Argentina
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Brussels, , Belgium
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Genk, , Belgium
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Merksem, , Belgium
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Mons, , Belgium
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Kelowna, British Columbia, Canada
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Victoria, British Columbia, Canada
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Kitchener, Ontario, Canada
Site Status
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Saint Catherines, Ontario, Canada
Site Status
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Toronto, Ontario, Canada
Site Status
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Trois-Rivières, Quebec, Canada
Site Status
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Beijing, , China
Site Status
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Bengbu, , China
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Changsha, , China
Site Status
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Guangzhou, , China
Site Status
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Hefei, , China
Site Status
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Jinan, , China
Site Status
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Shanghai, , China
Site Status
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Wuhan, , China
Site Status
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Varaždin, , Croatia
Site Status
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Zagreb, , Croatia
Site Status
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Brno, , Czechia
Site Status
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Bruntál, , Czechia
Site Status
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Hustopeče, , Czechia
Site Status
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Ostrava, , Czechia
Site Status
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Ostrava - Trebovice, , Czechia
Site Status
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Pardubice, , Czechia
Site Status
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Prague, , Czechia
Site Status
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Uherské Hradiště, , Czechia
Site Status
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Zlín, , Czechia
Site Status
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Cahors, , France
Site Status
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Limoges, , France
Site Status
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Montpellier, , France
Site Status
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Nantes, , France
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Orléans, , France
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Paris, , France
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Poitiers, , France
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Strasbourg, , France
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Thionville, , France
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Tours, , France
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Cologne, , Germany
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Gommern, , Germany
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Herne, , Germany
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Würzburg, , Germany
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Athens, , Greece
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Heraklion, , Greece
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Larissa, , Greece
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Marousi, , Greece
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Budapest, , Hungary
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Kiskunhalas, , Hungary
Site Status
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Nyíregyháza, , Hungary
Site Status
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Székesfehérvár, , Hungary
Site Status
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Veszprém, , Hungary
Site Status
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Aichi, , Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Hiroshima, , Japan
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Hokkaido, , Japan
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Hyōgo, , Japan
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Ibaraki, , Japan
Site Status
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Ibaraki, , Japan
Site Status
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Japan, , Japan
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Kagawa, , Japan
Site Status
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Kagoshima, , Japan
Site Status
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Kanagawa, , Japan
Site Status
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Kumamoto, , Japan
Site Status
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Mie, , Japan
Site Status
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Nagano, , Japan
Site Status
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Nagasaki, , Japan
Site Status
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Niigata, , Japan
Site Status
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Numakunai, , Japan
Site Status
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Okayama, , Japan
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Okinawa, , Japan
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Osaka, , Japan
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Ōita, , Japan
Site Status
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Saga, , Japan
Site Status
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Saitama, , Japan
Site Status
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Shizuoka, , Japan
Site Status
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Tochigi, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Toyama, , Japan
Site Status
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Yamaguchi, , Japan
Site Status
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Liepāja, , Latvia
Site Status
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Riga, , Latvia
Site Status
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Valmiera, , Latvia
Site Status
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Kaunas, , Lithuania
Site Status
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Klaipėda, , Lithuania
Site Status
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Šiauliai, , Lithuania
Site Status
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Guadalajara, , Mexico
Site Status
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Mexicali, , Mexico
Site Status
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Mérida, , Mexico
Site Status
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México, , Mexico
Site Status
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San Luis Potosí City, , Mexico
Site Status
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Tijuana, , Mexico
Site Status
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Bydgoszcz, , Poland
Site Status
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Elblag, , Poland
Site Status
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Gdansk, , Poland
Site Status
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Katowice, , Poland
Site Status
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Lodz, , Poland
Site Status
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Nadarzyn, , Poland
Site Status
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Warsaw, , Poland
Site Status
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Lisbon, , Portugal
Site Status
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Porto, , Portugal
Site Status
Ramon L. Ortega Colon
Carolina, , Puerto Rico
Site Status
Office of Dr. Ramon Toro
San Germán, , Puerto Rico
Site Status
Mindful Medical Research
San Juan, , Puerto Rico
Site Status
Latin Clinical Trial Center
Santurce, , Puerto Rico
Site Status
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Bucharest, , Romania
Site Status
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Cluj-Napoca, , Romania
Site Status
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Constanța, , Romania
Site Status
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Lasi, , Romania
Site Status
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Oradea, , Romania
Site Status
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Târgu Mureş, , Romania
Site Status
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Korolyov, , Russia
Site Status
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Moscow, , Russia
Site Status
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Ryazan, , Russia
Site Status
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Saint Petersburg, , Russia
Site Status
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Saratov, , Russia
Site Status
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Ulyanovsk, , Russia
Site Status
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Yaroslavl, , Russia
Site Status
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Bratislava, , Slovakia
Site Status
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Partizánske, , Slovakia
Site Status
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Spišská Nová Ves, , Slovakia
Site Status
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Topoľčany, , Slovakia
Site Status
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Ljubljana, , Slovenia
Site Status
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Maribor, , Slovenia
Site Status
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Durban, , South Africa
Site Status
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Greenacres, , South Africa
Site Status
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Pinelands, , South Africa
Site Status
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Stellenbosch, , South Africa
Site Status
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Daegu, , South Korea
Site Status
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Daejeon, , South Korea
Site Status
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Gwangju, , South Korea
Site Status
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Incheon, , South Korea
Site Status
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Seoul, , South Korea
Site Status
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Suwon, , South Korea
Site Status
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Barcelona, , Spain
Site Status
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Bilbao, , Spain
Site Status
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L'Hospitalet de Llobregat, , Spain
Site Status
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Madrid, , Spain
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Sabadell, , Spain
Site Status
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Santander, , Spain
Site Status
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Seville, , Spain
Site Status
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Valencia, , Spain
Site Status
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Villajoyosa, , Spain
Site Status
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Fribourg, , Switzerland
Site Status
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Kaohsiung City, , Taiwan
Site Status
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Neihu Taipei, , Taiwan
Site Status
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Taichung, , Taiwan
Site Status
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Taichung, , Taiwan
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Taipei, , Taiwan
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Yongkang District, , Taiwan
Site Status
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London, England, United Kingdom
Site Status
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London, Greater London, United Kingdom
Site Status
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Basingstoke, Hampshire, United Kingdom
Site Status
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Southampton, Hants, United Kingdom
Site Status
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Aberdeen, Scotland, United Kingdom
Site Status
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North Shields, Tyneside, United Kingdom
Site Status
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Bradford, West Yorkshire, United Kingdom
Site Status
Countries
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United States
Argentina
Belgium
Canada
China
Croatia
Czechia
France
Germany
Greece
Hungary
Japan
Latvia
Lithuania
Mexico
Poland
Portugal
Puerto Rico
Romania
Russia
Slovakia
Slovenia
South Africa
South Korea
Spain
Switzerland
Taiwan
United Kingdom
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
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.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I4V-MC-JADV
Identifier Type: OTHER
Identifier Source: secondary_id
13978
Identifier Type: -
Identifier Source: org_study_id
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