Study to Assess the Safety and Efficacy of Modified-Release Prednisone (Lodotra®) Therapy in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to compare the safety and efficacy, with regards to the signs and symptoms, of MR prednisone (Lodotra®) versus placebo in combination with standard Disease Modifying Anti-Rheumatic Drug (DMARD) treatment in patients with active rheumatoid arthritis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Horizon Pharma Ireland, Ltd., Dublin Ireland
• Treatments: Prednisone

Criteria

Inclusion Criteria:

• Documented history of RA in agreement with ACR criteria

• DMARD treatment for RA greater than or equal to 6 months, with a stable dose greater than or equal to 6 weeks prior to screening visit

• Duration of morning stiffness greater than or equal to 45 minutes

• greater than or equal to 4 swollen joints (out of 28)

• greater than or equal to 4 tender joints (out of 28)

Exclusion Criteria:

• Suffering from another disease, which requires glucocorticoid treatment during the study period

• Synovectomy within 4 months prior to study start

• Use of glucocorticoids:

• Continued use of systemic glucocorticoids within 4 weeks prior to screening visit

• Intermittent use of glucocorticoids within 2 weeks prior to screening visit.

• Joint injections within 6 weeks prior to screening visit

• Topical glucocorticoids must be stopped at screening visit

• Use of biologicals such as: tumor necrosis factor α (TNFα) inhibitors and other compounds within 5 serum half lives prior to screening visit

• Pregnancy or nursing