NCT01369745

A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

A Phase II, Double-Blind, Placebo-Controlled, Multi-Center, Randomized Withdrawal Design Trial Using Adaptive Randomization Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 294 (actual)
• Sponsor: Zalicus · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Thus study will test an experimental drug called Z-102 (combination of prednisolone and dipyridamole) to treat patients with moderate to severe rheumatoid arthritis.

Detailed description

The primary objective of the study was to demonstrate the efficacy of Z102 (2.7 mg prednisolone/360 mg dipyridamole) versus placebo on the Disease Activity Score 28 using C reactive protein (DAS28-CRP) in subjects with rheumatoid arthritis at the study endpoint of 12 weeks

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Prednisolone	Prednisolone 2.7 mg daily
DRUG	dipyridamole	dipyridamole 360 mg daily
DRUG	Prednisone	Prednisone 5 mg daily
DRUG	Z102	Prednisolone 2.7 mg plus dipyridamole 360 mg daily
OTHER	placebo

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2011-06-09
• Last updated: 2014-05-15
• Results posted: 2014-04-30

Locations

1 site across 1 country: United States