Psoriatic arthritis and psoriasis
Conditions
Interventions
Adalimumab 40 mg or placebo once every other week subcutaneous (first 4 weeks), open label adalimumab 40 mg after week 4.
Sponsors
Investigator initiated study
Work is carried out by AWR van Kuijk (Rheumatology), M de Groot and MA de Rie (Dermatology)
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with psoriatic arthritis and psoriasis; 2. Age 18-80 years; 3. At least 2 painful and 2 swollen joints; 4. Inadequate respons to NSAIDs; 5. Effective contraception; 6. Signed informed consent.
Exclusion criteria
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; 3. Other TNF-blocking treatment or treatment with another biological agent within 2 months of baseline; 4. Another skin or connective tissue disease that interferes with the assessment of psoriasis or psoriatic arthritis; 5. Active or latent tuberculosis; 6. Infection with HIV, hepatitis B or hepatitis C virus; 7. Severe comorbidity; 8. Malignancy other than basal cell carcinoma of skin within 10 years of baseline; 9. Pregnancy or breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week 4 compared baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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). | — |
Contacts
Public ContactA.W.R. Kuijk, van
Academic Medical Center (AMC), Division of Clinical Immunology & Rheumatology, F4-218, P.O. Box 22660
Outcome results
None listed