Clinical Trial: A Study of RO5310074 in Patients With Psoriatic Arthritis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-center, Randomized, Observer-blinded, Multiple-Ascending-Dose, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5310074 Following M
Brief Summary: 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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Safety: Incidence of adverse events [ Time Frame: 25 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL) [ Time Frame: 12 weeks ]
- Pharmacodynamics (anti-drug-antibodies) [ Time Frame: 25 weeks ]
Original Secondary Outcome:
- Pharmacokinetics (Cmax, t1/2, AUC, Vss, CL) [ Time Frame: 12 weeks ]
- Pharmacodynamics (anti-drug-antibodies, biomarkers) [ Time Frame: 25 weeks ]
Information By: Hoffmann-La Roche
Dates:
Date Received: September 9, 2010
Date Started: February 2011
Date Completion:
Last Updated: October 26, 2016
Last Verified: October 2016
