NCT01612377

Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis

A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis

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

Summary

This study will compare an experimental drug called Z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe Rheumatoid Arthritis for a period of 52 weeks.

Detailed description

This is a long-term Phase II safety study of approximately 52 weeks in duration. Eligible patients will have completed at least 6 weeks of Protocol Z102-008 and will have met all inclusion and exclusion criteria for this study. All patients will be up-titrated on Z102 over 3 weeks or will receive prednisone 5.0 mg or 7.5 mg: Primary objectives: * Adverse events (AEs) * Vital signs * Clinical laboratory and clinical chemistry evaluations Secondary objectives: * Joint imaging and bone density * DAS28-CRP and individual components * Patient Global Assessment of Disease Activity * American College of Rheumatology criteria (ACR 20, ACR 50, ACR 70) * Multidimensional Assessment of Fatigue (MAF) * Time to failure

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Prednisolone-Dipyridamole	Oral, QD
DRUG	Prednisone	Oral QD Prednisone 5mg
DRUG	prednisone	Oral, QD prednisone 7.5mg

Timeline

• Start date: 2012-03-01
• Primary completion: 2013-07-01
• Completion: 2013-09-01
• First posted: 2012-06-05
• Last updated: 2012-09-11

Locations

1 site across 1 country: Serbia