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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00542022
First Posted: October 10, 2007
Last Update Posted: October 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]

Enrollment: 149
Study Start Date: June 2004
Study Completion Date: May 2005
Primary Completion Date: May 2005 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542022


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00542022     History of Changes
Other Study ID Numbers: 0812-008
MK0812-008
2007_631
First Submitted: October 5, 2007
First Posted: October 10, 2007
Last Update Posted: October 20, 2015
Last Verified: October 2015

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