A Study of the Effects of Oral Prednisone in Patients With Rheumatoid Arthritis (MK0000-088)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo Tablets; Drug: Prednisone 7.5 mg; Drug: Prednisone 15 mg; Drug: Placebo Over-Encapsulated Tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT00746512

2008_531

0000-088

Details and patient eligibility

About

The study will compare the effects of prednisone vs placebo on synovial blood flow and overall DAS (disease activity score) in patients with rheumatoid arthritis.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is willing to limit alcohol intake to 3 or less beverages per day
• Patient agrees to use only acetaminophen/paracetamol for breakthrough pain

Exclusion criteria

• Patient has other inflammatory arthritis (e.g. lupus). Patient has had major surgery or donated or lost 1 unit of blood in the last 4 weeks
• Patient has a history of drug or alcohol abuse in the last 2 years
• Patient has had a vaccine (with a live or attenuated virus) in the last two weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 4 patient groups, including a placebo group

Prednisone 15 mg

Experimental group

Description:

Prednisone 15 mg tablets once daily for 15 days

Treatment:

Drug: Prednisone 15 mg

Placebo 15 mg

Placebo Comparator group

Description:

Prednisone 15 mg placebo tablets once daily for 15 days

Treatment:

Drug: Placebo Tablets

Prednisone 7.5 mg

Experimental group

Description:

Prednisone 7.5 mg over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Treatment:

Drug: Prednisone 7.5 mg

Placebo 7.5 mg

Placebo Comparator group

Description:

Prednisone 7.5 mg placebo over-encapsulated tablets once daily for 15 days As per adaptive dose-ranging design, this arm was added to the study because a difference between prednisone 15 mg and placebo was demonstrated during interim analysis.

Treatment:

Drug: Placebo Over-Encapsulated Tablets