This randomized, double-blind. placebo-controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of RO5310074 in patients with psoriatic arthritis who have or have had an inadequate response to oral disease-modifying antirheumatic drugs (DMARDs) or non-steroidal anti-rheumatic drugs (NSAIDs). Patients will be randomized in cohorts to receive either 6 intravenous doses of RO5310074 or placebo. Anticipated time on study treatment is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Unnamed facility
Anniston, Alabama, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Miami, Florida, United States
Unnamed facility
Duncansville, Pennsylvania, United States
Safety: Incidence of adverse events
Time frame: 25 weeks
Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL)
Time frame: 12 weeks
Pharmacodynamics (anti-drug-antibodies)
Time frame: 25 weeks
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Unnamed facility
Dallas, Texas, United States
Unnamed facility
San Antonio, Texas, United States
Unnamed facility
Melbourne, Victoria, Australia
Unnamed facility
Nedlands, Western Australia, Australia
Unnamed facility
Christchurch, New Zealand