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

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ClinicalTrials.gov Identifier: NCT00146640
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : February 19, 2014
Sponsor:
Information provided by:
Merck KGaA

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).

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Prednisone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 288 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : August 2004
Actual Primary Completion Date : January 2007
Actual Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone
U.S. FDA Resources




Primary Outcome Measures :
  1. duration of morning stiffness after 3 months of double-blind treatment with either formulation of prednisone

Secondary Outcome Measures :
  1. all other symptoms and routine assessments as usually measured in rheumatoid arthritis
  2. safety of long term treatment


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00146640


Locations
Germany
Research Site
Aachen, Germany
Research Site
Bad Kreuznach, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Erlangen, Germany
Research Site
Frankfurt/Main, Germany
Research Site
Hamburg, Germany
Research Site
Hannover, Germany
Research Site
Jena, Germany
Research Site
Köln, Germany
Research Site
Leipzig, Germany
Research Site
München, Germany
Research Site
Ratingen, Germany
Research Site
Rostock, Germany
Poland
Research Site
Bialystok, Poland
Research Site
Katowice, Poland
Research Site
Kraków, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Sopot, Poland
Research Site
Torun, Poland
Research Site
Warszawa, Poland
Research Site
Wroclaw, Poland
Sponsors and Collaborators
Merck KGaA
Investigators
Principal Investigator: Frank Buttgereit, Prof. Dr. University Medicine Berlin, Charité Campus Mitte, Berlin, Germany

Publications of Results:
ClinicalTrials.gov Identifier: NCT00146640     History of Changes
Other Study ID Numbers: EMR 62215-003
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: February 19, 2014
Last Verified: February 2014

Keywords provided by Merck KGaA:
active disease
morning stiffness of joints
nighttime application of prednisone
modified releae prednisone

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents