Rheumatoid Arthritis Dose Ranging Study
Information source: Merck
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: etoricoxib (Drug); Comparator: placebo (unspecified) (Drug); diclofenac (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Summary
To assess the clinically active dose range of study medication in the treatment of patients
with rheumatoid arthritis.
Clinical Details
Official title: A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The proportion of patients achieving the American College of Rheumatology Responder Index (20%) criteria (ACR20)
Secondary outcome: The number of tender joints; the number of swollen joints; the patient global assessment of disease activity; the investigator global assessment of disease activity, and the patient's assessment of pain.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is
otherwise judged to be in general good health and who is currently taking nonsteroidal
anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms. Patient will need to
stop taking these medications in order to participate, but can continue taking his/her
other anti-rheumatic medications as long as they have been stable for certain periods
of time.
Exclusion Criteria:
- Patients with a disease or medical condition(s) that could worsen or interfere with
the evaluation of the effectiveness of study medication are not allowed to
participate.
Locations and Contacts
Additional Information
Starting date: November 2005
Last updated: March 7, 2008
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