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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01597739
• Date of registration: 10/05/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study of JNJ-40346527 in Patients With Active Rheumatoid Arthritis Despite Disease-modifying Antirheumatic Drug Therapy
• Scientific 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
• Date of first enrolment: July 2012
• Target sample size: 96
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01597739
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

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

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: Placebo

Drug: JNJ-40346527

Primary Outcome(s)

Change from baseline in the Disease Activity Score (DAS28), using C-reactive protein (CRP) [Time Frame: Week 12]

Secondary Outcome(s)

ACR 20 response [Time Frame: Week 12]

DAS28 (using CRP) response [Time Frame: Week 12]

Secondary ID(s)

40346527ARA2001

2011-004529-28

CR100801

Source(s) of Monetary Support

Please refer to primary and secondary sponsors