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)

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

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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