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

Rheumatoid Arthritis Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01612377
• Study type: Interventional
• Source: Zalicus
• Status: Terminated
• Phase: Phase 2
• Start date: March 2012
• Completion date: September 2013