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

PHASE3CompletedINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

January 31, 2007

Study Completion Date

January 31, 2007

Conditions
Rheumatoid Arthritis
Interventions
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.

Trial Locations (24)

Unknown

Research Site, Aachen

Research Site, Bad Kreuznach

Research Site, Berlin

Research Site, Cologne

Research Site, Dresden

Research Site, Düsseldorf

Research Site, Erlangen

Research Site, Frankfurt am Main

Research Site, Hamburg

Research Site, Hanover

Research Site, Jena

Research Site, Leipzig

Research Site, München

Research Site, Ratingen

Research Site, Rostock

Research Site, Bialystok

Research Site, Katowice

Research Site, Krakow

Research Site, Lublin

Research Site, Poznan

Research Site, Sopot

Research Site, Torun

Research Site, Warsaw

Research Site, Wroclaw

All Listed Sponsors
lead

Merck KGaA, Darmstadt, Germany

INDUSTRY

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 | Biotech Hunter | Biotech Hunter