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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00132769 |
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Date of registration:
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02/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of a Novel Investigational Drug in Rheumatoid Arthritis Patients (MK-0873-012)(COMPLETED)
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Scientific title:
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A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind, 12-Week Study to Assess the Clinical Efficacy, Safety, and Tolerability of MK-0873 in Rheumatoid Arthritis |
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Date of first enrolment:
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January 2005 |
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Target sample size:
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106 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00132769 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Canada
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Czech Republic
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Finland
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Germany
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Italy
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Norway
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Spain
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Switzerland
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Contacts
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Merck Sharp & Dohme Corp. |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Rheumatoid arthritis, according to the American College of Rheumatology criteria, with
active disease despite current medications
- Other criteria also apply
Exclusion Criteria:
- Other major illnesses
- Past history of certain other disorders
- Certain prohibited medications
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: MK-0873
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Drug: Comparator: Placebo
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Primary Outcome(s)
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Change From Baseline in Swollen Joint Count
[Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12]
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Secondary Outcome(s)
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Patient Global Assessment of Disease Activity
[Time Frame: The average of Treatment Weeks 8, 10 and 12]
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Patient Global Assessment of Response to Therapy
[Time Frame: Treatment Week 12]
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Investigator Global Assessment of Disease Activity
[Time Frame: Treatment Week 12]
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Patient's Assessment of Pain
[Time Frame: Treatment Week 12]
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Change From Baseline in Tender Joint Count
[Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12]
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Health Assessment Questionnaire Disability Index
[Time Frame: The average of Treatment Weeks 8, 10 and 12]
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Ratio of On-treatment C-Reactive Protein to Baseline C-Reactive Protein
[Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12]
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Percentage of Participants With American College of Rheumatology 20% Response [ACR20]
[Time Frame: Baseline and the average of Treatment Weeks 8, 10 and 12]
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Secondary ID(s)
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0873-012
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2005_029
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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