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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00542022
First received: October 5, 2007
Last updated: May 21, 2014
Last verified: May 2014
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00542022     History of Changes
Other Study ID Numbers: 0812-008, MK0812-008, 2007_631
Study First Received: October 5, 2007
Last Updated: May 21, 2014
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 August 26, 2014