None listed
Conditions
Interventions
Group 1 Type of group
3 milligrams (mg) LY2439821 at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
Group name:Group 9 Type of group
Placebo at Weeks 0, 1, 2, 4, 6, 8 and 10, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
Sponsors
ELI LILLY AND COMPANY,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
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
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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. Measure:Dose-Response Relationship Measured by the Percentage of Participants With American College of Rheumatology (ACR) 20 Response in bDMARD-Naive Population Timepoints:Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:ACR20 responders were participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. Missing values were imputed using NRI. Percentage of participants achieving ACR20 response was calculated as: (number of ACR20 responders / number of participants treated) * 100. Measure:Percentage of Participants With ACR20 Response in Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR) Population Timepoints:Week 12 ; Outcome name:ACR20 responders are participants with at least 20% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. The model used in the dose response analysis was used to estimate the doses that achieved 10%, 50%, and 90% of the maximal drug efficacy. Missing values were imputed using NRI. The log transformed dose was evaluated. Measure:Smallest Doses That Achieve 10%, 50%, and 90% of the Maximum ACR 20 Response in bDMARD-Naive Population Timepoints:Week 12 ; Outcome name:DAS modified included the 28 diarthrodial joint count (DAS28) that consisted of a composite score of the following variables: TJC out of 28 (TJC28), SJC out of 28 (SJC28), CRP [milligrams per liter (mg/L)], and PtGADA on a 0 to 100 millimeter (mm) VAS ranging from 0 mm (no arthritis activity) to 100 mm (extremely active arthritis). DAS28 was calculated as: DAS28 − CRP = 0.56(square root of TJC28) + 0.28(square root of SJC28) + 0.36(ln[CRP +1]) + 0.014(VAS) + 0.96. Measure:Smallest Doses That Achieved 10%, 50%, and 90% of the Maximum Disease Activity Score (DAS) 28 Response in bDMARD-Naive Population Timepoints:Week 12 ; Outcome name:ACR50 responders were participants with at least 50% improvement from baseline for TJC, SJC, and at least 3 of the 5 remaining core set measures: HAQ-DI, CRP, PAAP-VAS, PtGADA-VAS, and PhGA-VAS. | — |
Countries
Argentina, Chile, Germany, India, Korea South, Peru, Poland, Romania, Russian Federation, Taiwan, United States
Contacts
Public ContactYngrid Saldarriaga
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed