A Phase 2 Dose-Ranging Study of Multiple Subcutaneous Doses of LY2439821 (an Anti-IL-17 Antibody) in Patients With Active Rheumatoid Arthritis on Concomitant DMARD Therapy
- Conditions
- -M069M069
- Registration Number
- PER-094-09
- Lead Sponsor
- ELI LILLY AND COMPANY,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 31
• 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
• 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 milliliters (mL) of blood within the last month
• You have received glucocorticoid administered by intra-articular, intramuscular, or intravenous 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 post-menopausal 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:ACR20 responders are participants with at least 20% improvement from baseline for tender joint count (TJC), swollen joint count (SJC), and at least 3 of the 5 remaining core set measures: Health Assessment Questionnaire-Disability Index (HAQ-DI) which measured participants perceived degree of difficulty performing daily activities, C-reactive Protein (CRP), Patients Assessment of Arthritis Pain-Visual Analog Scale (PAAP-VAS), Patients Global Assessment of Disease Activity-VAS(PtGADA-VAS), and Physicians Global Assessment of Disease Activity-VAS (PhGA-VAS). Missing values were imputed using Non-Responder Imputation (NRI). Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100.<br><br>Measure:Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population<br>Timepoints:Week 12<br>
- Secondary Outcome Measures
Name Time Method