Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

March 21, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

duration of morning stiffness after 3 months of double-blind treatment with either formulation of prednisone

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00146640 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

all other symptoms and routine assessments as usually measured in rheumatoid arthritis
safety of long term treatment

Original Secondary Outcome Measures ^ICMJE

all other symptoms and routine assessments as usuallly measured in rheumatoid arthritis
safety of longterm treatment

Descriptive Information

Brief Title ^ICMJE

Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis

Official Title ^ICMJE

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

Brief Summary

The objective of this study is to investigate if low doses of prednisone TRT, 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 prednisone given in the morning. Treatment duration per patient takes 12 months (the double-blind comparative study takes 3 months; 9 months subsequent open treatment on the TRT-medication).

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Rheumatoid Arthritis

Intervention ^ICMJE

Drug: Prednisone

Study Arms / Comparison Groups

Publications *

Buttgereit F, Doering G, Schaeffler A, Witte S, Sierakowski S, Gromnica-Ihle E, Jeka S, Krueger K, Szechinski J, Alten R. Efficacy of modified-release versus standard prednisone to reduce duration of morning stiffness of the joints in rheumatoid arthritis (CAPRA-1): a double-blind, randomised controlled trial. Lancet. 2008 Jan 19;371(9608):205-14.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

240

Completion Date

February 2007

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactive protein [CRP])
Stable condition
Stable basic treatments
Morning stiffness on previous treatment with standard prednisone (below or equal to 10mg per day) equal to or above 45 minutes

Exclusion Criteria:

All contra-indications for glucocorticoids
Pregnancy
Concomitant treatment with biologics
Intra-articular injections or synovectomy within the previous 4 months

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany, Poland

Administrative Information

NCT ID ^ICMJE

NCT00146640

Responsible Party

Study ID Numbers ^ICMJE

EMR 62215-003

Study Sponsor ^ICMJE

Merck KGaA

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Frank Buttgereit, Prof. Dr.

University Medicine Berlin, Charité Campus Mitte, Berlin, Germany

Information Provided By

Merck KGaA

Verification Date

March 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP