Clinical Trial to study effects of Baricitinib in Rheumatoid Arthritis patients with Inadequate Response to Conventional Drugs
- Conditions
- Health Condition 1: null- Patients with Moderately to Severely Active Rheumatoid Arthritis
- Registration Number
- CTRI/2013/12/004212
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 660
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 >= (greater than or equal to) 1.2 times the upper limit of normal (ULN)
-Have had an insufficient response or are intolerant to conventional disease-modifying antirheumatic drugs (cDMARDs) and either:
Have had regular use of a cDMARD for at least the 12 weeks prior to study entry with a continuous, nonchanging dose for at least 8 weeks prior to study entry
For participants not receiving a cDMARD at the time of entry, the investigator will document in the participants history that the participant had failed, was unable to tolerate, or had a contraindication to treatment with a cDMARD
-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 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 methotrexate (MTX), hydroxychloroquine, and sulfasalazine or combination of any 3 cDMARDs
-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 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 have 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)is greater than 1.5 times the ULN or the most recent available total bilirubin is greater than or equal to 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of Participants Achieving American College of Rheumatology 20 percent Improvement (ACR20) <br/ ><br>Timepoint: Time Frame: Week 12
- Secondary Outcome Measures
Name Time Method -Change from Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score <br/ ><br>-Change from Baseline in the Disease Activity Score based on a 28-Joint Count (DAS-28) <br/ ><br>-Change from Baseline in Patient Reported Outcomes <br/ ><br>-Proportion of Participants Achieving American College of Rheumatology 50 percent (ACR50) and 70 percent (ACR70) Response <br/ ><br>-Change from Baseline in Measures of Clinical Disease Activity and SeverityTimepoint: Time Frame: Baseline, Week 12 <br/ ><br> <br/ ><br>Time Frame: Baseline, Week 12 <br/ ><br> <br/ ><br>Time Frame: Baseline, up to Week 24 <br/ ><br> <br/ ><br>Time Frame: Week 12, Week 24 <br/ ><br> <br/ ><br>Time Frame: Baseline, up to Week 24