A Study in Participants With Moderate to Severe Rheumatoid Arthritis
NCT ID: NCT01711359
Last Updated: 2019-09-19
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
588 participants
Study Classification
INTERVENTIONAL
Study Start Date
2012-11-30
Study Completion Date
2015-08-31
Brief Summary
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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).
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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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Baricitinib + MTX
Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants received methotrexate (MTX) orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Group Type
EXPERIMENTAL
Baricitinib
Intervention Type
DRUG
Administered orally
Methotrexate
Intervention Type
DRUG
Administered orally
Folic Acid
Intervention Type
DRUG
Administered orally every day
Baricitinib
Baricitinib 4 mg administered orally once daily through Week 52. Participants received MTX placebo orally once weekly through Week 52. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Group Type
EXPERIMENTAL
Baricitinib
Intervention Type
DRUG
Administered orally
MTX Placebo
Intervention Type
DRUG
MTX placebo administered orally once weekly.
Folic Acid
Intervention Type
DRUG
Administered orally every day
MTX
MTX administered orally once weekly with dose ranging from 10 to 20 mg per week through Week 52. Participants also received baricitinib placebo orally once daily. Starting at Week 24, participants who were nonresponders were rescued with baricitinib 4 mg orally once daily and MTX orally once weekly.
Group Type
ACTIVE_COMPARATOR
Methotrexate
Intervention Type
DRUG
Administered orally
Baricitinib Placebo
Intervention Type
DRUG
Baricitinib placebo administered orally once daily.
Folic Acid
Intervention Type
DRUG
Administered orally every day
Interventions
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Baricitinib
Administered orally
Intervention Type
DRUG
Methotrexate
Administered orally
Intervention Type
DRUG
Baricitinib Placebo
Baricitinib placebo administered orally once daily.
Intervention Type
DRUG
MTX Placebo
MTX placebo administered orally once weekly.
Intervention Type
DRUG
Folic Acid
Administered orally every day
Intervention Type
DRUG
Other Intervention Names
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LY3009104
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American College of Rheumatology/ European League Against Rheumatism (ACR/EULAR) 2010 Criteria for the Classification of RA
* Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
* Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
* Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥1.2 times the upper limit of normal (ULN)
* Have had limited or no treatment with methotrexate (MTX)
* Have documented history of positive rheumatoid factor and/or cyclic citrullinated peptide (CCP) antibody test
* Have moderately to severely active RA defined as the presence of at least 6/68 tender joints and at least 6/66 swollen joints
* Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement ≥1.2 times the upper limit of normal (ULN)
* Have had limited or no treatment with methotrexate (MTX)
Exclusion Criteria
* Have received conventional disease-modifying antirheumatic drugs (DMARDs) other than MTX (eg, gold salts, cyclosporine, leflunomide, azathioprine, hydroxychloroquine, sulfasalazine or any other immunosuppressives)
* Are currently receiving corticosteroids at doses \>10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
* Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
* Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
* Have ever received any biologic DMARD
* Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
* Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require a parenteral injection of corticosteroids during the study
* Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
* Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
* Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis, or gout (Participants with secondary Sjogren's syndrome are not excluded.)
* Have a diagnosis of Felty's syndrome
* Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
* Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
* Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
* Have an estimated Glomerular Filtration Rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 milliliter per minute per 1.73 m\^2 (mL/min/1.73 m\^2)
* Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
* Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \<5 years
* Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
* Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
* Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
* Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
* Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
* Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study
* Have symptomatic herpes simplex at the time of study enrollment
* Have evidence of active or latent tuberculosis (TB)
* Are currently receiving corticosteroids at doses \>10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of study entry or within 6 weeks of planned randomization
* Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of study entry or within 6 weeks of planned randomization
* Have started a new physiotherapy treatment for RA in the 2 weeks prior to study entry
* Have ever received any biologic DMARD
* Have received interferon therapy within 4 weeks prior to study entry or are anticipated to require interferon therapy during the study
* Have received any parenteral corticosteroid administered by intramuscular or intravenous (IV) injection within 2 weeks prior to study entry or within 6 weeks prior to planned randomization or are anticipated to require a parenteral injection of corticosteroids during the study
* Have had 3 or more joints injected with intraarticular corticosteroids or hyaluronic acid within 2 weeks prior to study entry or within 6 weeks prior to planned randomization
* Have active fibromyalgia that, in the investigator's opinion, would make it difficult to appropriately assess RA activity for the purposes of this study
* Have a diagnosis of any systemic inflammatory condition other than RA, such as, but not limited to, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, active vasculitis, or gout (Participants with secondary Sjogren's syndrome are not excluded.)
* Have a diagnosis of Felty's syndrome
* Have had any major surgery within 8 weeks of study entry or will require major surgery during the study that, in the opinion of the investigator in consultation with Lilly or its designee, would pose an unacceptable risk to the participant
* Have experienced any of the following within 12 weeks of study entry: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association Stage IV heart failure
* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data
* Are largely or wholly incapacitated permitting little or no self care, such as, being bedridden or confined to a wheelchair
* Have an estimated Glomerular Filtration Rate (eGFR) based on the most recent available serum creatinine using the Modification of Diet in Renal Disease (MDRD) method of \<40 milliliter per minute per 1.73 m\^2 (mL/min/1.73 m\^2)
* Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the ULN or the most recent available total bilirubin ≥1.5 times the ULN
* Have a history of, lymphoproliferative disease; or have signs or symptoms suggestive of possible lymphoproliferative disease, including lymphadenopathy or splenomegaly; or have active primary or recurrent malignant disease; or have been in remission from clinically significant malignancy for \<5 years
* Have been exposed to a live vaccine within 12 weeks prior to planned randomization or are expected to need/receive a live vaccine during the course of the study (with the exception of herpes zoster vaccination)
* Have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection
* Have had symptomatic herpes zoster infection within 12 weeks prior to study entry
* Have a history of disseminated/complicated herpes zoster (eg, multidermatomal involvement, ophthalmic zoster, central nervous system involvement, postherpetic neuralgia)
* Are immunocompromised and, in the opinion of the investigator, are at an unacceptable risk for participating in the study
* Have a history of active hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
* Have screening laboratory test values, including thyroid-stimulating hormone (TSH), outside the reference range for the population or investigative site that, in the opinion of the investigator, pose an unacceptable risk for the participant's participation in the study
* Have screening electrocardiogram (ECG) abnormalities that, in the opinion of the investigator or the sponsor, are clinically significant and indicate an unacceptable risk for the participant's participation in the study
* Have symptomatic herpes simplex at the time of study enrollment
* Have evidence of active or latent tuberculosis (TB)
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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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Peoria, Arizona, United States
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El Cajon, California, United States
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Trumbull, Connecticut, United States
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Lewes, Delaware, United States
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Boynton Beach, Florida, United States
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Flowood, Mississippi, United States
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St Louis, Missouri, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Wyomissing, Pennsylvania, United States
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Jackson, Tennessee, United States
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Grapevine, Texas, United States
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Houston, Texas, United States
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Lubbock, Texas, United States
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Nassau Bay, Texas, United States
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Chesapeake, Virginia, United States
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Kennewick, Washington, United States
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Vancouver, Washington, United States
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Clarksburg, West Virginia, United States
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Franklin, Wisconsin, United States
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Buenos Aires, , Argentina
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Caba, , Argentina
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Córdoba, , Argentina
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La Plata, , 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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San Miguel de Tucumán, , Argentina
Site Status
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Vienna, , Austria
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Brussels, , Belgium
Site Status
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Genk, , Belgium
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Ghent, , Belgium
Site Status
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Liège, , Belgium
Site Status
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Mons, , Belgium
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Curitiba, , Brazil
Site Status
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Goiânia, , Brazil
Site Status
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São Paulo, , Brazil
Site Status
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Edmonton, Alberta, Canada
Site Status
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Victoria, British Columbia, Canada
Site Status
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Winnipeg, Manitoba, Canada
Site Status
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Kitchener, Ontario, Canada
Site Status
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Ottawa, Ontario, Canada
Site Status
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Saint Catherines, Ontario, Canada
Site Status
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Trois-Rivières, Quebec, Canada
Site Status
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Saskatoon, Saskatchewan, Canada
Site Status
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Bad Nauheim, , Germany
Site Status
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Bayreuth, , Germany
Site Status
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Berlin, , Germany
Site Status
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Gommern, , Germany
Site Status
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Hamburg, , Germany
Site Status
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Munich, , Germany
Site Status
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Ampelokipoi, , Greece
Site Status
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Heraklion, , Greece
Site Status
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Kifissia, , Greece
Site Status
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Larissa, , Greece
Site Status
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Ahmedabad, , India
Site Status
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Attavar, Mangalore, , India
Site Status
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Bangalore, , India
Site Status
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Belagavi, , India
Site Status
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Hyderabaad, , India
Site Status
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Jaipur, , India
Site Status
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Kolkata, , India
Site Status
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Lucknow, , India
Site Status
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Mumbai, , India
Site Status
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New Delhi, , India
Site Status
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Florence, , Italy
Site Status
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Genova, , Italy
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Milan, , Italy
Site Status
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Monza, , Italy
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Torino, , Italy
Site Status
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Valeggio sul Mincio, , Italy
Site Status
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Aichi, , Japan
Site Status
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Chiba, , Japan
Site Status
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Fukuoka, , Japan
Site Status
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Hiroshima, , Japan
Site Status
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Hokkaido, , Japan
Site Status
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Hyōgo, , 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
Site Status
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Okinawa, , Japan
Site Status
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Saitama, , Japan
Site Status
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Shizuoka, , Japan
Site Status
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Tokyo, , Japan
Site Status
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Toyama, , Japan
Site Status
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Guadalajara, , Mexico
Site Status
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Monterrey, , Mexico
Site Status
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San Luis Potosí City, , Mexico
Site Status
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Lisbon, , Portugal
Site Status
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Porto, , Portugal
Site Status
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Caguas, , Puerto Rico
Site Status
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Carolina, , Puerto Rico
Site Status
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San Germán, , Puerto Rico
Site Status
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San Juan, , Puerto Rico
Site Status
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Santurce, , Puerto Rico
Site Status
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Moscow, , Russia
Site Status
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Ryazan, , Russia
Site Status
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Ulyanovsk, , Russia
Site Status
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Yaroslavl, , Russia
Site Status
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Bloemfontein, , South Africa
Site Status
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Durban, , South Africa
Site Status
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Greenacres, , South Africa
Site Status
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Somerset West, , South Africa
Site Status
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Stellenbosch, , South Africa
Site Status
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Daejeon, , 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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Gothenburg, , Sweden
Site Status
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Huddinge, , Sweden
Site Status
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Malmo, , Sweden
Site Status
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Cambridge, Cambridgeshire, 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
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
North Shields, Tyneside, United Kingdom
Site Status
Countries
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United States
Argentina
Austria
Belgium
Brazil
Canada
Germany
Greece
India
Italy
Japan
Mexico
Portugal
Puerto Rico
Russia
South Africa
South Korea
Sweden
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, 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.
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
Fleischmann R, Takeuchi T, Schiff M, Schlichting D, Xie L, Issa M, Stoykov I, Lisse J, Martinez-Osuna P, Rooney T, Zerbini CAF. Efficacy and Safety of Long-Term Baricitinib With and Without Methotrexate for the Treatment of Rheumatoid Arthritis: Experience With Baricitinib Monotherapy Continuation or After Switching From Methotrexate Monotherapy or Baricitinib Plus Methotrexate. Arthritis Care Res (Hoboken). 2020 Aug;72(8):1112-1121. doi: 10.1002/acr.24007.
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
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
Schiff M, Takeuchi T, Fleischmann R, Gaich CL, DeLozier AM, Schlichting D, Kuo WL, Won JE, Carmack T, Rooney T, Durez P, Shaikh S, Hidalgo RP, van Vollenhoven R, Zerbini CAF. Patient-reported outcomes of baricitinib in patients with rheumatoid arthritis and no or limited prior disease-modifying antirheumatic drug treatment. Arthritis Res Ther. 2017 Sep 18;19(1):208. doi: 10.1186/s13075-017-1410-1.
Reference Type
DERIVED
Fleischmann R, Schiff M, van der Heijde D, Ramos-Remus C, Spindler A, Stanislav M, Zerbini CA, Gurbuz S, Dickson C, de Bono S, Schlichting D, Beattie S, Kuo WL, Rooney T, Macias W, Takeuchi T. Baricitinib, Methotrexate, or Combination in Patients With Rheumatoid Arthritis and No or Limited Prior Disease-Modifying Antirheumatic Drug Treatment. Arthritis Rheumatol. 2017 Mar;69(3):506-517. doi: 10.1002/art.39953.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
I4V-MC-JADZ
Identifier Type: OTHER
Identifier Source: secondary_id
14062
Identifier Type: -
Identifier Source: org_study_id
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