No registrations found.
ID
Source
Brief title
Health condition
Psoriatic arthritis and psoriasis
Sponsors and support
Work is carried out by AWR van Kuijk (Rheumatology), M de Groot and MA de Rie (Dermatology)
Intervention
Outcome measures
Primary outcome
Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week 4 compared baseline.
Secondary outcome
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).
Background summary
A monocenter, prospective, double blinded phase 4 trial in patients with psoriasis and psoriatic arthritis to study the effects of adalimumab on biological markers in skin and synovium. The trial has 2 phases: in the first 4 weeks patients are randomized and treated with adalimumab 40 mg or placebo (1:1), biopsies of skin and synovium (by arthroscopy of a large joint) are collected at baseline and week 4; after week 4 all patients are treated with adalimumab open label and followed up to week 12.
Study objective
Find the best predictive biomarker for respons to treatment.
Study design
N/A
Intervention
Adalimumab 40 mg or placebo once every other week subcutaneous (first 4 weeks), open label adalimumab 40 mg after week 4.
P.O. Box 22660
A.W.R. Kuijk, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
a.w.vankuijk@amc.uva.nl
P.O. Box 22660
A.W.R. Kuijk, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
a.w.vankuijk@amc.uva.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL833 |
| NTR-old | NTR846 |
| Other | : N/A |
| ISRCTN | ISRCTN23328456 |