Prednisone Timed-Release Tablet (TRT) Study: Modified-Release (MR) Formulation of Prednisone Compared to Standard Immediate-Release (IR) Prednisone in Participants With Rheumatoid Arthritis

Last updated: June 4, 2018
Sponsor: Merck KGaA, Darmstadt, Germany
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00146640
EMR 62215-003
  • Ages 18-80
  • All Genders

Study Summary

The objective of this study is to investigate if low doses of prednisone MR formulation, 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 IR prednisone given in the morning.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Active disease (inflammatory signs, erythrocyte sedimentation rate [ESR], C-reactiveprotein [CRP])

  • Stable condition

  • Stable basic treatments

  • Morning stiffness on previous treatment with standard prednisone (below or equal to 10mg per day) greater than or equal to (>/=) 45 minutes

Exclusion

Exclusion Criteria:

  • All contra-indications for glucocorticoids

  • Pregnancy

  • Concomitant treatment with biologics

  • Intra-articular injections or synovectomy within the previous 4 months

Study Design

Total Participants: 288
Study Start date:
August 31, 2004
Estimated Completion Date:
January 31, 2007

Connect with a study center

  • Research Site

    Aachen,
    Germany

    Site Not Available

  • Research Site

    Bad Kreuznach,
    Germany

    Site Not Available

  • Research Site

    Berlin,
    Germany

    Site Not Available

  • Research Site

    Dresden,
    Germany

    Site Not Available

  • Research Site

    Düsseldorf,
    Germany

    Site Not Available

  • Research Site

    Düsseldorf,
    Germany

    Site Not Available

  • Research Site

    Erlangen,
    Germany

    Site Not Available

  • Research Site

    Frankfurt/Main,
    Germany

    Site Not Available

  • Research Site

    Hamburg,
    Germany

    Site Not Available

  • Research Site

    Hannover,
    Germany

    Site Not Available

  • Research Site

    Jena,
    Germany

    Site Not Available

  • Research Site

    Köln,
    Germany

    Site Not Available

  • Research Site

    Köln,
    Germany

    Site Not Available

  • Research Site

    Leipzig,
    Germany

    Site Not Available

  • Research Site

    München,
    Germany

    Site Not Available

  • Research Site

    München,
    Germany

    Site Not Available

  • Research Site

    Ratingen,
    Germany

    Site Not Available

  • Research Site

    Rostock,
    Germany

    Site Not Available

  • Research Site

    Bialystok,
    Poland

    Site Not Available

  • Research Site

    Katowice,
    Poland

    Site Not Available

  • Research Site

    Kraków,
    Poland

    Site Not Available

  • Research Site

    Kraków,
    Poland

    Site Not Available

  • Research Site

    Lublin,
    Poland

    Site Not Available

  • Research Site

    Poznan,
    Poland

    Site Not Available

  • Research Site

    Sopot,
    Poland

    Site Not Available

  • Research Site

    Torun,
    Poland

    Site Not Available

  • Research Site

    Warszawa,
    Poland

    Site Not Available

  • Research Site

    Wroclaw,
    Poland

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.