Back to resultsEfficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
Primary Purpose
Arthritis, Rheumatoid
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
MK0812 / Duration of Treatment: 12 Weeks
Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks
Sponsored by
About this trial
This is an interventional treatment trial for Arthritis, Rheumatoid
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
Sites / Locations
Outcomes
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
Secondary Outcome Measures
MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients
Full Information
NCT ID
NCT00542022
First Posted
October 5, 2007
Last Updated
October 19, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00542022
Brief Title
Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
To demonstrate the clinical effectiveness of MK0812 in the treatment of Arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthritis, Rheumatoid
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
149 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0812 / Duration of Treatment: 12 Weeks
Intervention Type
Drug
Intervention Name(s)
Comparator: placebo (unspecified) / Duration of Treatment: 12 Weeks
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
MK0812 once daily for 12 weeks will be safe and well tolerated in Arthritis patients
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Efficacy, Tolerability and Safety Study in Rheumatoid Arthritis (0812-008)
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