Active Rheumatoid Arthritis; Rheumatoid Arthritis Clinical Trial
Official title:
A Phase 2b Randomized, Double-blind, Multicenter, Placebo-controlled, Parallel-group, Dose Range Finding Study of JNJ-39758979 in Subjects With Active Rheumatoid Arthritis Despite Concomitant Methotrexate Therapy
The purpose of the study is to assess the efficacy, safety and tolerability of JNJ-39758979 at doses of 10, 30, 100, and 300 mg/day compared with placebo (inactive medical substance) in patients with active rheumatoid arthritis despite concomitant treatment with methotrexate (MTX).
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | March 2014 |
| Est. primary completion date | March 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Has a diagnosis of rheumatoid arthritis (RA) for at least 6 months before screening. - Positive test for either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum at screening. - Has active RA defined as persistent disease activity with the following criteria: at least 6 swollen and 6 tender joints, and serum CRP = 0.70 mg/dL at screening. - Has been treated with and tolerated methotrexate (MTX) treatment at dosages of 10 to 25 mg/week for a minimum of 6 months prior to screening and must be on a stable dose for a minimum of 8 weeks prior to screening - Must be post-menopausal or if pre-menopausal, must use an acceptable form of birth control - Has completed at least 5 days of daily pain diary in the 10 days prior to randomization. Exclusion Criteria: - Has inflammatory diseases other than RA, such as Lupus. - Is currently receiving treatment for RA other than methotrexate, NSAIDS, or oral corticosteroids such as prednisone, or pain medicines. - Has ever received any biologic agent for a rheumatic indication. - Has current signs or symptoms of liver insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled. - Has moderate or severe renal insufficiency - Has a recent (within 2 months) serious infection - Has had an opportunistic infection. - Has had cancer within the past 5 years (except certain skin or cervical conditions) - Has abused substances or alcohol within the past 2 years - Has active Hepatitis B or C infection - Has had active tuberculosis - Has had exposure to tuberculosis without preventative treatment |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Janssen Research & Development, LLC |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The primary end point is change from baseline in Disease Activity Score 28 (DAS28) (CRP) at Week 12 | Baseline, Week 12 | No | |
| Secondary | Change from baseline in DAS28 (CRP) at Week 24 | Baseline, Week 24 | No | |
| Secondary | Change from baseline in DAS28 (ESR) at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | No | |
| Secondary | DAS28 (CRP) response rates at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | DAS28 (ESR) response rates at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | DAS28 (CRP) remission rates at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | American college of rheumatology (ACR) 20/50/70 response rates at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | Hybrid ACR response at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | ACR/European League Against Rheumatism (EULAR) remission rates at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | Change from baseline in Simplified Disease Activity Index (SDAI) at Week 12 and Week 24 | Baseline, Week 12, Week 24 | No | |
| Secondary | Change from baseline in Clinical Disease Activity Index (CDAI) at Week 12 and Week 24 | Baseline, Week 12, Week 24 | No | |
| Secondary | Health Assessment Questionnaire - Disability Index (HAQ-DI) response at Week 12 and Week 24 | Week 12, Week 24 | No | |
| Secondary | Change from baseline in HAQ-DI score at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | No | |
| Secondary | Percent change from baseline in ESR levels at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | No | |
| Secondary | Percent change from baseline in ACR components at Week 12 and Week 24 | Baseline, Week 12 and Week 24 | No |