Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00542022
First received: October 5, 2007
Last updated: September 23, 2009
Last verified: September 2009
  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 2

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Estimated Enrollment: 150
Study Start Date: May 2004
Study Completion Date: May 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
ClinicalTrials.gov Identifier: NCT00542022     History of Changes
Other Study ID Numbers: 2007_631, MK0812-008
Study First Received: October 5, 2007
Last Updated: September 23, 2009
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014