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

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.

Timeline

Start

2008-03

Primary completion

2009-05

Completion

2009-05

Outcome

Met primary endpoint

registry NP01 vs Placebo; p = 0.0010; Odds Ratio (OR) 2.25 (95% CI 1.39 to 3.64) NCT00650078 ↗

paper MR prednisone plus DMARD treatment produced higher response rates for ACR20 (48% vs 29%, p<0.001) PMID 22562974 ↗

Publications

• Alten R, Grahn A, Holt RJ, Rice P, Buttgereit F. Delayed-release prednisone improves fatigue and health-related quality of life: findings from the CAPRA-2 double-blind randomised study in rheumatoid arthritis. RMD Open. 2015 Aug 13;1(1):e000134. doi: 10.1136/rmdopen-2015-000134. eCollection 2015.
• Buttgereit F, Mehta D, Kirwan J, Szechinski J, Boers M, Alten RE, Supronik J, Szombati I, Romer U, Witte S, Saag KG. Low-dose prednisone chronotherapy for rheumatoid arthritis: a randomised clinical trial (CAPRA-2). Ann Rheum Dis. 2013 Feb;72(2):204-10. doi: 10.1136/annrheumdis-2011-201067. Epub 2012 May 5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisone	Other / unclassified	5 mg	—

Indications