A Multi-Center Trial to Compare Three Doses of Meloxicam and Placebo in Patients With Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Arthritis, Rheumatoid
- Registration Number
- NCT00042068
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
A 12-week trial consisting of 5 visits (6 if follow up is needed) to find out how effective and safe three different doses of meloxicam are compared with placebo in Rheumatoid Arthritis. Patient will take one dose of study medication daily.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Age greater than or equal to 18 and less than or equal to 80
- Diagnosis of Rheumatoid Arthritis for at least six weeks
- Taking an NSAID
- If female: using adequate contraception
- Willingness to stop current NSAID until criteria reached to begin study drug
- Able to provide written informed consent
Exclusion Criteria
- Intolerance or hypersensitivity to NSAIDs or ingredients of trial drug
- Pregnancy, lactating
- Use of investigational drug within 30 days prior to entering the trial
- History of peptic ulcer or of gastrointestinal hemorrhage except simple hemorrhoidal bleeding
- History of cerebrovascular or other bleeding disorder
- Severe hypertension
- Other disease that might interfere with safety of the patient or evaluation of trial drug (investigator's opinion)
- RA of functional class IV
- Synovectomy in any large joint within the past 6 months prior to entering the trial or planned during trial
- Concomitant therapy with anticoagulant, therapeutic doses of aspirin, phenothiazines, lithium, chronic GI-medication, analgesic drug (except acetaminophen up to 4 grams/day)
- DMARDs initiated within past three months or dose changed less than two months before entering the trial
- Therapy with corticosteroids exceeding 10 mg/day prednisone equivalent or change in dose within 1 month before trial
- Concomitant therapy with ACTH within past month before entering the trial.
- History of narcotic or alcohol abuse (past 12 months)
- Abnormal laboratory values
- Previous participation in the present trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Response according to American College of Rheumatology 20% (ACR20) classification at 12 weeks
- Secondary Outcome Measures
Name Time Method Number of painful or tender joints up to 12 weeks Number of swollen joints up to 12 weeks Patient's global (overall) assessment of disease activity up to 12 weeks Investigator's global (overall) assessment of disease activity up to 12 weeks Patient's assessment of pain up to 12 weeks Patient's assessment of physical function (mHAQ) up to 12 weeks Withdrawal due to lack of efficacy up to 12 weeks Use of rescue medication up to 12 weeks Patient's final global assessment of tolerability at end of 12 weeks Patient's final global (overall) assessment of efficacy at end of 12 weeks Incidence and intensity of adverse events until 4 weeks post treatment Withdrawals due to adverse events at end of 12 weeks C-Reactive Protein (CRP) up to 12 weeks Duration of morning stiffness up to of 12 weeks Investigator's final global (overall) assessment of efficacy at end of 12 weeks Patient status with regard to change in arthritic condition at end of 12 weeks Investigator's final global assessment of tolerability at end of 12 weeks
Trial Locations
- Locations (83)
Suites 570 (research) & 600 (PI)
🇺🇸Huntsville, Alabama, United States
Suite 200
🇺🇸Dallas, Texas, United States
Suite 140
🇺🇸Anchorage, Alaska, United States
#106
🇺🇸Glendale, Arizona, United States
Suite 601
🇺🇸Phoenix, Arizona, United States
Suite 201
🇺🇸Phoenix, Arizona, United States
Boehringer Ingelheim Investigational Site
🇰🇷Seoul, Korea, Republic of
Suite 100
🇺🇸Charlotte, North Carolina, United States
Suite 208
🇺🇸San Diego, California, United States
Suite 202
🇺🇸Kalamazoo, Michigan, United States
Scroll for more (73 remaining)Suites 570 (research) & 600 (PI)🇺🇸Huntsville, Alabama, United States