| - candidate number | 2374 |
| - NTR Number | NTR846 |
| - ISRCTN | ISRCTN23328456 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 19-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis. |
| - Scientific Title | Effects of adalimumab (Humira) on biomarkers in skin and synovial tissue in patients with psoriatic arthritis. |
| - ACRONYM | ADAPs |
| - hypothesis | Find the best predictive biomarker for respons to treatment. |
| - Healt Condition(s) or Problem(s) studied | Psoriasis, Psoriatic arthritis |
| - 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. |
| - mec approval received | yes |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Double |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-feb-2006 |
| - planned closingdate | 1-mei-2007 |
| - Target number of participants | 24 |
| - Interventions | Adalimumab 40 mg or placebo once every other week subcutaneous (first 4 weeks), open label adalimumab 40 mg after week 4. |
| - 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). |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion stopped: follow-up |
| - CONTACT FOR PUBLIC QUERIES | A.W.R. Kuijk, van |
| - CONTACT for SCIENTIFIC QUERIES | Prof. Dr. P.P. Tak |
| - Sponsor/Initiator | Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology |
| - Funding (Source(s) of Monetary or Material Support) | Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology |
| - Publications | N/A |
| - Brief 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. |
| - Main changes (audit trail) | |
| - RECORD | 19-dec-2006 - 29-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl