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

September 6, 2005
February 17, 2014
August 2004
January 2007   (final data collection date for primary outcome measure)
duration of morning stiffness after 3 months of double-blind treatment with either formulation of prednisone
Same as current
Complete list of historical versions of study NCT00146640 on ClinicalTrials.gov Archive Site
  • all other symptoms and routine assessments as usually measured in rheumatoid arthritis
  • safety of long term treatment
  • all other symptoms and routine assessments as usuallly measured in rheumatoid arthritis
  • safety of longterm treatment
Not Provided
Not Provided
 
Prednisone Timed-Release Tablet (TRT) Study: TRT Formulation of Prednisone Compared to Standard Prednisone in Patients With Rheumatoid Arthritis
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

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Rheumatoid Arthritis
Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
288
January 2007
January 2007   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Poland
 
NCT00146640
EMR 62215-003
Not Provided
Not Provided
Merck KGaA
Not Provided
Principal Investigator: Frank Buttgereit, Prof. Dr. University Medicine Berlin, Charité Campus Mitte, Berlin, Germany
Merck KGaA
February 2014

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