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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR846 |
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Date of registration:
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19/12/2006 |
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Primary sponsor: |
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Public title:
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A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis.
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Scientific title:
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Effects of adalimumab (Humira) on biomarkers in skin and synovial tissue in patients with psoriatic arthritis. - ADAPs |
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Date of first enrolment:
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1/2/2006 |
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Target sample size:
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24 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=846 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Double; Control: Placebo; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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P.P.
Tak |
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Address:
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Academic Medical Center (AMC), Department of Clinical Immunology and Rheumatology,
P.O. Box 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5662171 |
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Email:
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p.p.tak@amc.nl |
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Affiliation:
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Name:
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A.W.R.
Kuijk, van |
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Address:
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Academic Medical Center (AMC), Division of Clinical Immunology & Rheumatology, F4-218,
P.O. Box 22660
1100 DD
Amsterdam
The Netherlands |
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Telephone:
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+31 (0)20 5662171 |
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Email:
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a.w.vankuijk@amc.uva.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Psoriasis, Psoriatic arthritis
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Intervention(s)
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Adalimumab 40 mg or placebo once every other week subcutaneous (first 4 weeks), open label adalimumab 40 mg after week 4.
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Primary Outcome(s)
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Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week 4 compared baseline.
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Secondary Outcome(s)
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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).
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Secondary ID(s)
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ISRCTN23328456
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N/A
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Source(s) of Monetary Support
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Academic Medical Center (AMC), Division of Clinical Immunology and Rheumatology
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