A Rheumatoid Arthritis Study in Patients
- Conditions
- Health Condition 1: null- Rheumatoid Arthritis
- Registration Number
- CTRI/2011/07/001867
- 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
- 1002
Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
-Global Assessment of Disease Activity visual analog scale (VAS)greater than or equal to 20/100 mm
-If on one or more conventional DMARDs at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
-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
-Use of biologic DMARD concurrently or recently
-History of a serious reaction to other biological DMARDs
-Use of an oral calcineurin inhibitor (e.g., cyclosporin or tacrolimus) in the last 8 weeks
-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 human immunodeficiency virus (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)Timepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method