Health Condition 1: null- Patients with Moderately to Severely Active Rheumatoid Arthritis
Conditions
Interventions
Intervention1: Baricitinib and Methotrexate: Baricitinib 4 milligram (mg) administered orally once daily through Week 52. Participants will receive methotrexate (MTX) orally once weekly with dose rang
Sponsors
Eli Lilly and Company
Eligibility
Inclusion criteria
Inclusion criteria: -Have a diagnosis of adult-onset rheumatoid arthritis (RA) as defined by American College of Rheumatology or European League Against Rheumatism (ACR or 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 per 68 tender joints and at least 6 per 66 swollen joints -Have a C-reactive protein (CRP) or high-sensitivity C-reactive protein (hsCRP) measurement greater than equal to 1.2 times the upper limit of normal (ULN) -Have had limited or no treatment with methotrexate (MTX)
Exclusion criteria
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 greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within two 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 investigators 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, Crohns disease, ulcerative colitis, psoriatic arthritis, active vasculitis, or gout (Participants with secondary Sjogrens syndrome are not excluded) -Have a diagnosis of Feltys 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 less than 40 milliliter per minute per 1.73 m2 (mL/min/1.73 m2) -Have a history of chronic liver disease with the most recent available aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 1.5 times the ULN or the most recent available total bilirubin greater than equal to 1.5 times the ULN -Have a history of, lymphoproliferative disease, or have signs or symptoms suggestive of p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of Participants Achieving American College of Rheumatology 20 percent Improvement (ACR20)Timepoint: Time Frame: Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Change from Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score -Change from Baseline in the Disease Activity Score based on a 28-Joint Count (DAS-28) -Change from Baseline in the modified Total Sharp Score (mTSS) -Proportion of Participants Achieving American College of Rheumatology 50 percent (ACR50) and 70 percent (ACR70) Response -Change from Baseline in Patient Reported Outcomes -Change from Baseline in Measures of Clinical Disease Activity and SeverityTimepoint: Time Frame: Baseline, Week 24 Time Frame: Baseline, Week 24 Time Frame: Baseline, Week 24 Time Frame: Week 12, Week 24, Week 52 Time Frame: Baseline, up to Week 52 Time Frame: Baseline, up to Week 52 | — |
Countries
Argentina, Austria, Belgium, Brazil, Canada, Germany, Greece, India, Italy, Japan, Mexico, Portugal, Russian Federation, South Africa, Sweden, United Kingdom, United States of America
Contacts
Public ContactAnil Seth
Eli Lilly and Company India Private Limited
Outcome results
None listed