Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2

Conditions: Arthritis, Rheumatoid

Treatments: Drug: MK0812 / Duration of Treatment: 12 Weeks; Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542022

2007_631

0812-008

MK0812-008

Details and patient eligibility

About

To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.

Enrollment: 149 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient has had diagnosis of RA made at least 6 months prior to study start and was greater than 16 years of age when diagnosed
• Patient has active RA with a minimum level of disease activity including at least 10 swollen joints and 10 tender or painful joints
• Excepting rheumatoid arthritis, patient is judged to be in otherwise general good health based on medical history, physical examination, and routine laboratory tests

Exclusion criteria

• Patient is mentally or legally incapacitated, has significant emotional problems at the time of the study, or has a history of psychosis
• Patient has a history of any clinically significant disease of the cardiovascular, hepatic, neurological, renal, genitourinary, or hematologic systems or uncontrolled blood pressure
• Female patient is pregnant or breast-feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind