None listed
Conditions
Interventions
Patients orally self-administered two placebo for 12 weeks.
Group name:Celecoxib 200 mg Type of group
Patients orally self-administered a Celecoxib 200 mg capsule and a celecoxib placebo capsule for 12 weeks.
Sponsors
PHARMACIA & UPJOHN INTERAMERICAN CORPORATION,
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 C-Reactive protein. Measure:Efficacy of celecoxib 400 mg QD veisus placebo in the treatment of signs and symptoms of psoriatic arthritis. Timepoints:The visits of Weeks 2 and 6 and in the Final visit (in week 12 or Early Termination). | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Global Assessment of Arthritis by the Patient Global Evaluation of Arthritis by the Physician Evaluation of Sensitive / Painful Joints Evaluation of Swollen Joints Evaluation of Arthritis Pain by the Patient (EAV) Evaluation of Physical Function by the Patient (CESm) Duration of Morning Rigidity Health Survey SF-36 Incidence and Time for Withdrawal due to Treatment Failure Measure:1. Compare celecoxib 200 mg QD with placebo in the treatment of signs and symptoms of psoriatic arthritis. 2. Compare celecoxib 200 mg QD and celecoxib 400 mg QD in the treatment of signs and symptoms of psoriatic arthritis. 3. Compare celecoxib 200 mg QD and celecoxib 400 mg QD versus placebo in terms of safety, tolerability and quality of life. Timepoints:The visits of Weeks 2 and 6 and in the Final visit (in week 12 or Early Termination). | — |
Countries
Peru
Outcome results
None listed