A Study of the Efect of JNJ-40346527 and Placebo in Patients with Active Rheumatoid Arthritis
- Conditions
- Rheumatoid ArthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2011-004529-28-BG
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Principal Inclusion Criteria in Lay Language (for a complete list of inclusion criteria refer to the protocol):
- Have had rheumatoid arthritis (RA) for at least 6 months prior to screening.
- Have been positive for, or are positive at screening for, either anti-cyclic citrullinated peptide (anti-CCP) antibody or rheumatoid factor (RF) in serum.
- Have active RA with at least 6 swollen and 6 tender joints, using a 66/68 joint count at the time of screening and at baseline, and serum CRP = 0.80 mg/dL at screening.
- Have been treated with and tolerated at least one of the following medications 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: methotrexate (MTX) treatment at dosages of 7.5 to 25 mg/week, inclusive; sulfasalazine not exceeding 3 g/d; hydroxychloroquine not exceeding 400 mg/d.
- If using nonsteroidal antiinflammatory drugs (NSAIDs), or other analgesics regularly for RA, patients must have been on a stable dose for at least 2 weeks prior to the first administration of study agent. If not using NSAIDs or other analgesics for RA, the patient must have not received NSAIDs or other analgesics for at least 2 weeks prior to the first administration of study agent.
- If using oral corticosteroids, must be on a stable dose of = 10 mg/day of prednisone or an equipotent dose of another oral corticosteroid for at least 2 weeks prior to the first administration of study agent. If not using corticosteroids, the patient must have not received oral corticosteroids for at least 2 weeks prior to the first administration of study agent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 76
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 14
Principal Exclusion Criteria in Lay Language (for a complete list of exclusion criteria refer to the protocol):
- Has inflammatory diseases other than RA, including but not limited to adult onset Still’s disease, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy.
- Has a history of juvenile idiopathic arthritis (JIA).
- Has current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive, or uncontrolled.
- Has been treated in the time frames specified with any nonbiologic disease-modifying antirheumatic drugs (DMARDs), except for MTX, sulfasazine, and hydroxychloroquine, including, but not limited to: D-penicillamine, oral or parenteral gold salts, azathioprine, cyclosporine, tacrolimus, and mycophenolate mofetil within 4 weeks prior to the first administration of study agent; leflunomide within 12 weeks prior to the first administration of study agent unless the patient has undergone a drug elimination procedure at least 4 weeks prior to the first administration of study agent; any investigational nonbiologic DMARD within 4 weeks prior to the first administration of study agent or 5 half-lives of the DMARD, whichever is longer.
- Has ever received any approved or investigational biologic antirheumatic agent. These agents include, but are not limited to, infliximab, golimumab, certolizumab pegol, etanercept, adalimumab, abatacept, rituximab, tocilizumab, or anakinra.
- Has received drugs that potently inhibit or induce cytochrome P450 (CYP450) 3A4, CYP2C8, or CYP2C19 isoforms within 2 weeks or within 5 half-lives of the drug, whichever is longer, prior to the first dose of study medication.
- Has received intra-articular, epidural, intravertebral, intramuscular, or intravenous corticosteroids, including adrenocorticotropic hormone, within 4 weeks prior to the first dose of study medication.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objectives are to assess the safety, tolerability, and efficacy (change from baseline in Disease Activity Score 28 [DAS28] using C-reactive protein [CRP]) of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks compared with placebo in subjects with active RA despite DMARD therapy.;Secondary Objective: The secondary objectives are: <br>•To assess the efficacy of JNJ-40346527 as measured by American College of Rheumatology (ACR) 20 and 50 response rates at Week 12.<br><br>•To characterize the population pharmacokinetics (PK) of JNJ-40346527 in adults with active RA despite DMARD therapy.<br>;Primary end point(s): The primary endpoint is change from baseline in DAS28 (using CRP) at Week 12 ;Timepoint(s) of evaluation of this end point: week 12
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Major Secondary Endpoints:<br>•ACR 20 response rates at Week 12<br><br>• DAS28 (using CRP) response rates at Week 12<br><br>Other Secondary Endpoints:<br>•ACR 50/70 response rates at Week 12 <br><br>•Change from baseline in DAS28 (using ESR) at Week 12<br><br>•DAS28 (using ESR) response rates at Week 12<br><br>• HAQ-DI response at Week 12<br><br>•Change from baseline in HAQ-DI score at Week 12<br><br>• Percent change from baseline in ESR levels at Week 12<br><br>• Percent change from baseline in ACR components at Week 12<br><br>•Change from baseline in Simplified Disease Activity Index at Week 12<br><br>• Change from baseline in Clinical Disease Activity Index at Week 12;Timepoint(s) of evaluation of this end point: week 12