A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)

Summary

The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Timeline

Start

2008-09

Primary completion

2009-09

Completion

2009-09

Outcome

Mixed primary results

paper The primary endpoint was the summated score of power Doppler area measured quantitatively in all 10 MCPJs in the transverse plane at Day 15. PMID 22972032 ↗

paper The comparison between daily 15 mg prednisone and placebo at Day 15 yielded a statistically significant treatment effect (effect size = 1.17, P = 0.013) PMID 22972032 ↗

paper but borderline for prednisone 7.5 mg daily versus placebo (effect size = 0.61, P = 0.071). PMID 22972032 ↗

Publications

• Results Seymour MW, Kelly S, Beals CR, Malice MP, Bolognese JA, Dardzinski BJ, Cheng AS, Cummings CE, Smugar SS, McClinton C, Fox A, Dooley WM, Pitzalis C, Taylor PC. Ultrasound of metacarpophalangeal joints is a sensitive and reliable endpoint for drug therapies in rheumatoid arthritis: results of a randomized, two-center placebo-controlled study. Arthritis Res Ther. 2012 Sep 12;14(5):R198. doi: 10.1186/ar4034.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Prednisone	Other / unclassified	7.5 mg	Oral
Subject	Prednisone	Other / unclassified	15 mg	Oral

Indications