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

• Register: ClinicalTrials.gov
• Last refreshed on: 2 November 2015
• Main ID: NCT00542022
• Date of registration: 05/10/2007
• Prospective Registration: No
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
• Scientific title: A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK0812 in Rheumatoid Arthritis Patients
• Date of first enrolment: June 2004
• Target sample size: 149
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00542022
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Contacts

• Name: Medical Monitor
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid

Intervention(s)

Drug: MK0812 / Duration of Treatment: 12 Weeks

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

Primary Outcome(s)

MK0812 once daily for 12 weeks will demonstrate clinical effectiveness superior to placebo for treatment of Arthritis, as assessed by changes from baseline in the patient's swollen joint count [Time Frame: 12 weeks]

Secondary Outcome(s)

MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients [Time Frame: 12 weeks]

Secondary ID(s)

0812-008

MK0812-008

2007_631

Source(s) of Monetary Support

Please refer to primary and secondary sponsors