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

This study has been completed.
Sponsor:
Information provided by:
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00146640
First received: September 6, 2005
Last updated: February 17, 2014
Last verified: February 2014
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


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

Enrollment: 288
Study Start Date: August 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
ClinicalTrials.gov Identifier: NCT00146640     History of Changes
Other Study ID Numbers: EMR 62215-003
Study First Received: September 6, 2005
Last Updated: February 17, 2014
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:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 29, 2014