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

Merck KGaA (EMD Serono) logo

Merck KGaA (EMD Serono)

Status and phase

Completed
Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo - MR Prednisone
Drug: MR Prednisone
Drug: IR Prednisone
Drug: Placebo - IR Prednisone

Study type

Interventional

Funder types

Industry

Identifiers

NCT00146640
EMR 62215-003

Details and patient eligibility

About

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.

Enrollment

288 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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 10 mg per day) greater than or equal to (>/=) 45 minutes

Exclusion criteria

  • All contra-indications for glucocorticoids
  • Pregnancy
  • Concomitant treatment with biologics
  • Intra-articular injections or synovectomy within the previous 4 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

288 participants in 2 patient groups

MR Prednisone
Experimental group
Description:
Participants will receive MR prednisone at bed time and placebo matching to IR prednisone in the morning. Total duration of double blind treatment will be 12 weeks.
Treatment:
Drug: Placebo - IR Prednisone
Drug: MR Prednisone
IR Prednisone
Active Comparator group
Description:
Participants will receive IR prednisone in the morning and placebo matching to MR prednisone at bed time. Total duration of double blind treatment will be 12 weeks.
Treatment:
Drug: IR Prednisone
Drug: Placebo - MR Prednisone

Trial contacts and locations

24

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Data sourced from clinicaltrials.gov

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