A DOUBLE BLIND COMPARISON CONTROLLED WITH PLACEBO, RANDOMIZED OF THE EFFICACY AND SAFETY OF CELECOXIB 200 MG AND CELECOXIB 400MG ONCE A DAY IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF PSORIASTIC ARTHRITIS
Not Applicable
- Conditions
- -M07M07
- Registration Number
- PER-018-02
- Lead Sponsor
- PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
• The patients has an established diagnosis of Psoriasis.
• The patients has a presentation of psoriatic arthritis as a compromise of distal intephalangeal joints, asymmetric peripheral arthritis or symmetric poly arthritis.
• The patients is a man or woman 18 years of age or older.
Exclusion Criteria
• The patients has any other inflammatory arthritis (eg, rheumatoid arthritis).
• The patients has a positive rheumatoid factor (> 20 lU / ml).
• The patients has a history of Inflammatory Bowel Disease.
• The patients has a significant secondary non-inflammatory arthritis (eg, severe osteoarthritis).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:The main measure of effectiveness will be the response to treatment based on the Response Index of the American College of Rheumatology (CAR-20). The CAR-20 are criteria that are based on a reduction of at least 20% in the counting of sensitive and painful joints as well as a 20% reduction in at least three of the following evaluations: Patient Pain Assessment, Global Evaluation by the Patient, Global Evaluation by the Physician, evaluation of the Physical Function by the Patient (CESm) and<br>C-Reactive protein.<br>Measure:Efficacy of celecoxib 400 mg QD veisus placebo in the treatment of signs and symptoms of psoriatic arthritis.<br>Timepoints:The visits of Weeks 2 and 6 and in the Final visit (in week 12 or Early Termination).<br>
- Secondary Outcome Measures
Name Time Method <br>Outcome name:Global Assessment of Arthritis by the Patient<br>Global Evaluation of Arthritis by the Physician<br>Evaluation of Sensitive / Painful Joints<br>Evaluation of Swollen Joints<br>Evaluation of Arthritis Pain by the Patient (EAV)<br>Evaluation of Physical Function by the Patient (CESm)<br>Duration of Morning Rigidity<br>Health Survey SF-36<br>Incidence and Time for Withdrawal due to Treatment Failure<br>Measure:1. Compare celecoxib 200 mg QD with placebo in the treatment of signs and symptoms of psoriatic arthritis.<br>2. Compare celecoxib 200 mg QD and celecoxib 400 mg QD in the treatment of signs and symptoms of psoriatic arthritis.<br>3. Compare celecoxib 200 mg QD and celecoxib 400 mg QD versus placebo in terms of safety, tolerability and quality of life.<br>Timepoints:The visits of Weeks 2 and 6 and in the Final visit (in week 12 or Early Termination).<br>