NCT00326339

Treatment of Arthritis With Syk Kinase Inhibition (TASKI-1)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose, Dose Ranging Study to Evaluate Up to Three Doses of R935788 in Rheumatoid Arthritis Patients Failing to Respond to Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Rigel Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, ascending dose, dose ranging study to evaluate up to three doses of R935788 (50 mg bid, 100 mg bid and 150 mg bid). Approximately 180 patients who have had rheumatoid arthritis for a minimum of 12 months and who have been receiving a weekly methotrexate (MTX) dose for a minimum of 6 months will be enrolled into the study.

Detailed description

The primary objective of this study is to assess the preliminary efficacy of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks The secondary objectives of this study are to assess the safety of up to three different dosage regimens of R788 as determined by ACR 20 responder rates at 12 weeks, and to assess the general clinical and laboratory safety evaluations throughout the study.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	R788	R788 50 mg, 100 mg, or 150 mg PO bid
DRUG	Placebo	Placebo PO bid

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-10-01
• Completion: 2007-12-01
• First posted: 2006-05-16
• Last updated: 2009-04-20

Locations

38 sites across 2 countries: United States, Mexico