A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis.
Completed
- Conditions
- Psoriatic arthritis and psoriasis
- Registration Number
- NL-OMON25856
- Lead Sponsor
- Investigator initiated studyWork is carried out by AWR van Kuijk (Rheumatology), M de Groot and MA de Rie (Dermatology)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1. Patients with psoriatic arthritis and psoriasis;
2. Age 18-80 years;
Exclusion Criteria
1. Use of another DMARD than methotrexate within 4 weeks of baseline;
2. Intra-articular injection with corticosteroids within 4 weeks of baseline;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week 4 compared baseline.
- Secondary Outcome Measures
Name Time Method 1. Clinical and functional scores at week 4 and week 12 compared to baseline: Psoriasis Area and Severity Index (PASI), Tender Joint Count (TJC), Swollen Joint Count (SJC), Visual Analogue Scale (VAS) for disease activity by patient and physician, levels of ESR and CRP in blood, Health Assessment Questionnaire (HAQ).