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

Arthritis, Rheumatoid Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542022
• Other study ID #: 0812-008
• Secondary ID: MK0812-0082007_6
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2007
• Last updated: October 19, 2015
• Start date: June 2004
• Est. completion date: May 2005

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Drug:
• MK0812 / Duration of Treatment: 12 Weeks

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 weeks
Secondary	MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients		12 weeks