A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

Arthritis, Rheumatoid Clinical Trial

Official title:

A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel-group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01597739
• Other study ID #: CR100801
• Secondary ID: 40346527ARA20012
• Status: Completed
• Phase: Phase 2
• First received: May 10, 2012
• Last updated: April 7, 2014
• Start date: July 2012
• Est. completion date: April 2013

Study information

• Verified date: April 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeCzech Republic: State Institute for Drug ControlHungary: National Institute for Quality and Organizational Development in Healthcare and MedicinesUkraine: State Pharmacological Center - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-40346527 200 mg/day (100 mg twice daily) for 12 weeks, compared with placebo, in patients with active rheumatoid arthritis (RA) despite disease-modifying antirheumatic drug (DMARD) therapy.

Description:

This is a randomized (treatment assigned by chance, like flipping a coin), multicenter, double-blind (neither physician nor patient will know the treatment the patient receives), parallel-group (each group of patients will be treated at the same time) study. JNJ-40346527 will be compared to a placebo, which is an inactive substance used to test whether a drug has a real effect. Patients will receive study medication for 12 weeks and will continue their permitted, stable DMARD therapy (methotrexate [MTX], sulfasalazine [SSZ], and/or hydroxychloroquine [HCQ]) through Week 12. A follow-up visit will occur 4 weeks after dosing is complete. The maximum length of patient participation will be 22 weeks, including a 6-week screening period. Other study visits will occur during the study, and patient safety will be monitored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of 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 C-reactive protein (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

Exclusion Criteria:

• 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 subject 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• JNJ-40346527
Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
• Placebo
Form=capsule; route=oral use; twice daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Chile,  Czech Republic,  Hungary,  Korea, Republic of,  Poland,  Russian Federation,  Singapore,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP)	The DAS28 is a statistically derived index combining tender joints (28 joints), swollen joints (28 joints), CRP, and an overall assessment of disease activity.	Week 12	No
Secondary	ACR 20 response	ACR 20 (American College of Rheumatology) response is a 20% improvement in rheumatoid arthritis (RA) symptoms.	Week 12	No
Secondary	DAS28 (using CRP) response	DAS28 response is the improvement from baseline and is rated as "No response," Moderate response," or "Good response."	Week 12	No

External Links

•   A Phase 2a, Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Group Study of JNJ-40346527 in Subjects With Active Rheumatoid Arthritis Despite Disease Modifying Antirheumatic Drug Therapy