Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00542022

Purpose

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

Condition	Intervention	Phase
Arthritis, Rheumatoid	Drug: MK0812 / Duration of Treatment: 12 Weeks Drug: Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks	Phase II

MedlinePlus related topics: Rheumatoid Arthritis

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0812 in Rheumatoid Arthritis Patients

Further study details as provided by Merck:

Primary Outcome Measures:

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 Measures:

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542022

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2007_631
Study First Received:	October 5, 2007
Last Updated:	November 29, 2007
ClinicalTrials.gov Identifier:	NCT00542022
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Study placed in the following topic categories:

Autoimmune Diseases
Musculoskeletal Diseases
Joint Diseases
Arthritis

Connective Tissue Diseases
Arthritis, Rheumatoid
Rheumatic Diseases

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 15, 2009