NCT00146640

Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

A New Timed-Release Tablet Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis- A Randomized, Multi-Centre, Double-Blind, Active Controlled Study With Open Extension on the New Drug Only

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 288 (actual)
• Sponsor: Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to investigate if low doses of prednisone MR formulation, given at night and, with active drug release at 2 am, are more effective in controlling joint stiffness, and other disease symptoms of rheumatoid arthritis than standard IR prednisone given in the morning.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	MR Prednisone	Participants will receive tablets containing MR prednisone (to achieve the appropriate dose of 3-10 milligrams \[mg\] prednisone per day) at bed time.
DRUG	IR Prednisone	Participants will receive tablets containing IR prednisone (to achieve the appropriate dose of 3-10 mg prednisone per day) in the morning.
DRUG	Placebo - MR Prednisone	Participants will receive placebo matching to MR prednisone tablet at bed time.
DRUG	Placebo - IR Prednisone	Participants will receive placebo matching to IR prednisone tablet in the morning.

Timeline

• Start date: 2004-08-31
• Primary completion: 2007-01-31
• Completion: 2007-01-31
• First posted: 2005-09-07
• Last updated: 2018-07-03
• Results posted: 2018-05-29

Locations

24 sites across 2 countries: Germany, Poland