Find the best predictive biomarker for respons to treatment.
ID
Bron
Verkorte titel
Aandoening
Psoriatic arthritis and psoriasis
Ondersteuning
Work is carried out by AWR van Kuijk (Rheumatology), M de Groot and MA de Rie (Dermatology)
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week 4 compared baseline.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Find the best predictive biomarker for respons to treatment.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
Adalimumab 40 mg or placebo once every other week subcutaneous (first 4 weeks), open label adalimumab 40 mg after week 4.
Publiek
P.O. Box 22660
A.W.R. Kuijk, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
a.w.vankuijk@amc.uva.nl
Wetenschappelijk
P.O. Box 22660
A.W.R. Kuijk, van
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5662171
a.w.vankuijk@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL833 |
| NTR-old | NTR846 |
| Ander register | : N/A |
| ISRCTN | ISRCTN23328456 |