A Study in Patients With Rheumatoid Arthritis

Phase 2

Completed

• Registration Number: CTRI/2009/091/000777
• Lead Sponsor: Eli Lilly

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 372

Inclusion Criteria

You must be between the ages of 18 and 75
You must have active RA

Qualifications Specific to the bDMARD-naive Population:

You must be regularly using methotrexate (MTX) for at least 12 weeks before your participation in this study

Qualifications Specific to the TNFα-IR Population:

You must have been treated with at least 1 biologic TNFα inhibitor therapy and either had an insufficient response to at least 3 months of treatment OR have been intolerant of such treatment
You must be regularly using at least 1 conventional DMARD in a stable treatment regimen

Exclusion Criteria

You are concomitantly using non-steroidal anti-inflammatory drugs (NSAIDS), unless you are on a stable dose within the last 2 weeks
You are a woman who is lactating or breast feeding
You have donated more than 300 mL of blood within the last month
You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous (IV) injection or oral corticosteroids at an average daily dose of greater than 10 mg per day of prednisone or its equivalent within the last 4 weeks
You had surgery on a joint that is to be assessed in the study within 2 months of study enrollment, or will require such during the study
You have another serious disorder or illness
You suffered a serious bacterial infection (for example, pneumonia, cellulitis, or bone or joint infections) within the last 3 months
You have a history of uncontrolled high blood pressure
You have clinical laboratory test results at entry that are outside the normal reference range
You are an employee of the clinic or you are an immediate family member of an employee of the clinic. Immediate family member is defined as a spouse, parent, child, or sibling, whether biological or legally adopted
You are currently participating in or were discontinued within the last 30 days from another clinical trial involving an investigational drug
If you are a woman and you could become pregnant during this study, you must talk to the study doctor about the birth control that you will use to avoid getting pregnant during the study.
If you are a post menopausal woman, you must be at least 45 years of age and have not menstruated for the last 12 months
If you are a woman between 40 and 45 years of age, test negative for pregnancy, and have not menstruated during the last 12 months only, you must have an additional blood test to see if you can participate.
If you are male, you must agree to reduce the risk of your female partner becoming pregnant during the study.
Exclusions Specific to the bDMARD-naive Population:

You have received any prior biologic DMARD therapy such as TNFα, IL-1, IL-6, T-cell, or B-cell targeted therapies
You have had an inadequate response to a minimum of 3 months of treatment with 5 or more conventional DMARDs (such as leflunomide, azathioprine, cyclosporine, etc)
You have used DMARDs other than MTX, hydroxychloroquine, or sulfasalazine within the last 8 weeks
You have used leflunomide within the last 12 weeks and have not received cholestyramine to speed up the elimination of leflunomide from your body.
Exclusions Specific to the TNFα-IR Population:

You are currently using or recently used a biologic DMARD or a biologic TNFα inhibitor therapy within specified periods
You have had a serious reaction to other biologic DMARDs that, in the study doctor's opinion, puts you at serious risk
You have used cyclosporine or any other immunosuppressive in the 8 weeks before your participation in this study

Study & Design

• Study Type: Interventional
• Study Design: Not specified