None listed
Conditions
Interventions
Drug : Subjects will be randomly assigned in a 2:1 ratio to receive JNJ-40346527 100 mg twice daily or placebo
twice daily. Study agent will be provided as JNJ-40346527 50 mg capsules or matching plac
Sponsors
Janssen Korea
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The subject population comprises men and women aged 18 to 80 years, inclusive. Subjects must have had RA for at least 6 months, and have active disease despite MTX, SSZ, and/or HCQ therapy. Active disease is defined as at least 6 tender joints out of 68 and 6 swollen joints out of 66 at screening and baseline and a serum CRP = 0.80 mg/dL at screening. Subjects must have been on MTX, SSZ, and/or HCQ therapy for at least 6 months prior to screening, with a stable dose for a minimum of 8 weeks prior to screening. Subjects are permitted to be receiving oral corticosteroids (prednisone = 10 mg/d, or equivalent corticosteroid) provided their dose has been stable for at least 2 weeks prior to the first study agent administration. Subjects are also permitted to be receiving nonsteroidal anti-inflammatory drugs or other analgesics provided their dose has been stable for at least 2 weeks prior to the first study agent administration.
Exclusion criteria
Exclusion criteria: Subjects will be excluded from the study if they have been treated with any biologic antirheumatic agent in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in DAS 28 (using CRP) at week12 | — |
Secondary
| Measure | Time frame |
|---|---|
| ACR20 responses rates at week12 | — |
Countries
Korea, Republic of
Contacts
Public ContactKyoungHee Lee
Seoul National University Hospital
Outcome results
None listed