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

NCT ID: NCT00542022

Last Updated: 2015-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-06-30
• Study Completion Date: 2005-05-31

Brief Summary

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

Conditions

Arthritis, Rheumatoid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

MK0812 / Duration of Treatment: 12 Weeks

Intervention Type: DRUG

Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

MK0812-008

Identifier Type: -

Identifier Source: secondary_id

2007_631

Identifier Type: -

Identifier Source: secondary_id

0812-008

Identifier Type: -

Identifier Source: org_study_id