None listed
Conditions
Interventions
Intervention1: LY2439821: 3 to 180 mg, subcutaneous at weeks 0, 1, 2, 4, 6, 8 10
(bDMARD-naive population)
80 - 180 mg, subcutaneous at weeks 0, 1, 2, 4, 6, 8, 10 (TNFa-IR population)
Both populations
Sponsors
Eli Lilly
Eligibility
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-response relationship measured by the proportion of American College of Rheumatology (ACR) 20 responders; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive) onlyTimepoint: week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Actual value of American College of Rheumatology (ACR)-NTimepoint: Through week 72;anti-LY2439821 antibodiesTimepoint: Through week 72;Change from baseline in Disease Activity Score (DAS28Timepoint: Baseline, through week 72;Change from baseline in duration of morning stiffness (minutes)Timepoint: Baseline, through week 72;Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue ScaleTimepoint: Baseline, through week 72;Change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)Timepoint: Baseline, through week 72;Change from baseline in individual components of the American College of Rheumatology (ACR) core setTimepoint: Baseline, through week 72;Pharmacokinetics CmaxTimepoint: Through week 72;Proportion of American College of Rheumatology (ACR) 20 responders; Tumor Necrosis Factor alpha - inadequate responder population (TNFa-IR) onlyTimepoint: week 12;Proportion of American College of Rheumatology (ACR) 20/50/70 respondersTimepoint: Through week 72;Proportion of patients in European League Against Rheumatism Responder Index (EULAR28)Timepoint: Through week 72;Relationship between exposure and response of American College of Rheumatology (ACR) 20/50/70/NTimepoint: Through week 72;Relationship between exposure and response of Disease Activity Score (DAS) 28Timepoint: Through week 72;Relationship between exposure and response of European League Against Rheumatism (EULAR) 28Timepoint: Through week 72;Relationship between exposure and response of individual components of the American College of Rheumatology (ACR) core setTimepoint: Through week 72;Smallest doses that achieve 10%, 50%, and 90% of the maximum American College of Rheumatology (ACR) 20 response; Biologic disease modifying anti-rheumatic drug-naive population (bDMARD-naive)Timepoint: Week 12;Smallest doses that achieve 10%, 50%, and 90% of the maximum American College of Rheumatology (ACR) 50 response; Biologic disease modifying anti-rheumatic drug-nai | — |
Countries
India
Contacts
Public ContactAnil Seth
Outcome results
None listed