NCT01199809

A Study of RO5310074 in Patients With Psoriatic Arthritis

A Multi-center, Randomized, Observer-blinded, Multiple-Ascending-Dose, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO5310074 Following Multiple Intravenous Administrations in Subjects With Psoriatic Arthritis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arthritis, Psoriatic

Interventions

Type	Name	Description
DRUG	Placebo	multiple doses
DRUG	RO5310074	multiple ascending doses

Timeline

• Start date: 2011-02-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2010-09-13
• Last updated: 2016-10-27

Locations

9 sites across 3 countries: United States, Australia, New Zealand