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

NCT ID: NCT01597739

Last Updated: 2014-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-04-30

Brief 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.

Detailed 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.

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JNJ-40346527

Group Type: EXPERIMENTAL

JNJ-40346527

Intervention Type: DRUG

Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Form=capsule; route=oral use; twice daily.

Interventions

JNJ-40346527

Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.

Intervention Type: DRUG

Placebo

Form=capsule; route=oral use; twice daily.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Research & Development, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Research & Development, LLC

Locations

Buenos Aires, , Argentina

San Juan, , Argentina

San Miguel de Tucumán, , Argentina

Plovdiv, , Bulgaria

Sevlievo, , Bulgaria

Veliko Tarnovo, , Bulgaria

Providencia, , Chile

Santiago, , Chile

Prague, , Czechia

Slaný, , Czechia

Budapest, , Hungary

Hatvan, , Hungary

Szikszó, , Hungary

Elblag, , Poland

Poznan, , Poland

Warsaw, , Poland

Kazan', , Russia

Moscow, , Russia

Novosibirsk, , Russia

Petrozavodsk, , Russia

Saint Petersburg, , Russia

Ulyanovsk, , Russia

Yaroslavl, , Russia

Singapore, , Singapore

Gwangju, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Donetsk, , Ukraine

Kharkiv, , Ukraine

Ternopil, , Ukraine

Vinnitsa, , Ukraine

Zaporizhzhya, , Ukraine

Countries

Argentina; Bulgaria; Chile; Czechia; Hungary; Poland; Russia; Singapore; South Korea; Ukraine

References

Genovese MC, Hsia E, Belkowski SM, Chien C, Masterson T, Thurmond RL, Manthey CL, Yan XD, Ge T, Franks C, Greenspan A. Results from a Phase IIA Parallel Group Study of JNJ-40346527, an Oral CSF-1R Inhibitor, in Patients with Active Rheumatoid Arthritis despite Disease-modifying Antirheumatic Drug Therapy. J Rheumatol. 2015 Oct;42(10):1752-60. doi: 10.3899/jrheum.141580. Epub 2015 Aug 1.

Reference Type: DERIVED

PMID: 26233509 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3469&filename=CR100801_CSR.pdf

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

Other Identifiers

40346527ARA2001

Identifier Type: OTHER

Identifier Source: secondary_id

2011-004529-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR100801

Identifier Type: -

Identifier Source: org_study_id