A Rheumatoid Arthritis Study in Patients on a Background Treatment of Methotrexate
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2011/07/001870
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 990
Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
-Regular use of methotrexate (MTX) in the past 12 weeks, with the dose being stable during the past 8 weeks
-At least 8 tender and swollen joints
-At least one erosion of a hand or foot joint observed on an X-ray
-An abnormally high C-reactive protein (CRP) level or erythrocyte sedimentation rate (ESR)
-Positive for Rheumatoid Factor (RF) or Anti-cyclic citrullinated peptide (CCP) antibody
-Woman must not be pregnant, breastfeeding, or become pregnant during the study
-Age limit in India per Office of Drug Controller General India is 18 years to 65 years
-Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
-Steroid injection or intravenous (iv) infusion in the last 6 weeks
-Use of more than 10 mg/day of oral steroids in the last 6 weeks
-History of an inadequate response to a biologic disease-modifying anti-rheumatic drug (DMARD)
-History of a serious reaction to other biological DMARDs
-History of the use of rituximab or other B cell therapy
-Use of DMARDS other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
-Use of leflunomide within the last 12 weeks (unless cholestyramine was used to speed up the elimination of leflunomide)
-Surgery on a joint or other major surgery less than 2 months ago, or plans to have joint surgery or major surgery during the study
-Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohns disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
-Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
-Received a live vaccine received within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
-Hepatitis or HIV
-A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
-Symptoms of herpes zoster or herpes simplex within the last month
-Active or latent tuberculosis (TB)
-Current symptoms of a serious disorder or illness
-Use of an investigational drug within the last month
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of patients with American College of Rheumatology 20% response (ACR20) at Week 24 <br/ ><br> <br/ ><br>Change from baseline to Week 52 in van der Heijde modified Total Sharp Score (mTSS) <br/ ><br> <br/ ><br>Change from baseline to Week 24 in Health Assessment Questionnaire-Disability Index (HAQ-DI)Timepoint: 24 weeks <br/ ><br> <br/ ><br>Baseline, 52 weeks <br/ ><br> <br/ ><br>Baseline, 24 weeks <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method