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

This study has been completed.

First Received: September 6, 2005 Last Updated: March 21, 2009 History of Changes

Sponsor:	Merck KGaA
Information provided by:	Merck KGaA
ClinicalTrials.gov Identifier:	NCT00146640

Purpose

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).

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: Prednisone	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Prednisone

U.S. FDA Resources

Further study details as provided by Merck KGaA:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	240
Study Start Date:	August 2004
Estimated Study Completion Date:	February 2007

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146640

Locations

Germany
Research Site
Berlin, Germany
Research Site
Leipzig, Germany
Research Site
Jena, Germany
Research Site
Erlangen, Germany
Research Site
Frankfurt/Main, Germany
Research Site
Köln, Germany
Research Site
Hamburg, Germany
Research Site
Rostock, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Ratingen, Germany
Research Site
München, Germany
Research Site
Hannover, Germany
Research Site
Bad Kreuznach, Germany
Research Site
Aachen, Germany
Poland
Research Site
Wroclaw, Poland
Research Site
Warszawa, Poland
Research Site
Poznan, Poland
Research Site
Katowice, Poland
Research Site
Kraków, Poland
Research Site
Torun, Poland
Research Site
Sopot, Poland
Research Site
Bialystok, Poland
Research Site
Lublin, Poland

Sponsors and Collaborators

Merck KGaA

Investigators

Principal Investigator:

Frank Buttgereit, Prof. Dr.

University Medicine Berlin, Charité Campus Mitte, Berlin, Germany

More Information

No publications provided by Merck KGaA

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	EMR 62215-003
Study First Received:	September 6, 2005
Last Updated:	March 21, 2009
ClinicalTrials.gov Identifier:	NCT00146640 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Merck KGaA:

active disease
morning stiffness of joints
nighttime application of prednisone
modified releae prednisone

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Prednisone
Autoimmune Diseases
Antineoplastic Agents, Hormonal
Immune System Diseases
Antineoplastic Agents
Joint Diseases
Physiological Effects of Drugs
Arthritis, Rheumatoid

Hormones, Hormone Substitutes, and Hormone Antagonists
Rheumatic Diseases
Glucocorticoids
Hormones
Pharmacologic Actions
Musculoskeletal Diseases
Therapeutic Uses
Arthritis
Connective Tissue Diseases

ClinicalTrials.gov processed this record on February 08, 2010