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ISRCTN
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ISRCTN23328456
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ClinicalTrials.gov identifier
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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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Acronym
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ADAPs
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Serial number at source
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N/A
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Study hypothesis
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Find the best predictive biomarker for response to treatment.
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Lay summary
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Ethics approval
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Approval received from the Medical Ethical Committee of the Academic Medical Centre/University of Amsterdam on the 10th August 2005 (ref: MEC 05/162).
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Study design
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Randomised, placebo controlled, parallel group, double blinded, trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Psoriatic arthritis, psoriasis
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Participants - inclusion criteria
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1. Patients with psoriatic arthritis and psoriasis
2. Age 18 to 80 years
3. At least two painful and two swollen joints
4. Inadequate respons to Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
5. Effective contraception
6. Signed informed consent
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Participants - exclusion criteria
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1. Use of another Disease Modifying Anti-Rheumatic Drugs (DMARD) than methotrexate within four weeks of baseline
2. Intra-articular injection with corticosteroids within four weeks of baseline
3. Other Tumour Necrotising Factor (TNF)-blocking treatment or treatment with another biological agent within two 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 Human Immunodeficiency Virus (HIV), hepatitis B or hepatitis C virus
7. Severe comorbidity
8. Malignancy other than basal cell carcinoma of skin within ten years of baseline
9. Pregnancy or breastfeeding
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Anticipated start date
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01/02/2006
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Anticipated end date
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01/05/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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24
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Interventions
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Adalimumab 40 mg or placebo once every other week subcutaneous (first four weeks), open label adalimumab 40 mg after week four.
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Primary outcome measure(s)
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Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week four compared to baseline.
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Secondary outcome measure(s)
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1. Clinical and functional scores at week four 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 Erythrocyte Sedimentation Rate (ESR) and C-Reactive Protein (CRP) in blood, Health Assessment Questionnaire (HAQ).
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Sources of funding
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Academic Medical Center (AMC) (The Netherlands)
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Trial website
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Publications
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1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20844595
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Contact name
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Dr
A W R
van Kuijk
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Address
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Academic Medical Center (AMC)
Division of Clinical Immunology and Rheumatology, F4-218
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Tel
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+31 (0)20 566 2171
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Email
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a.w.vankuijk@amc.uva.nl
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Sponsor
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Academic Medical Center (AMC) (The Netherlands)
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Address
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Division of Clinical Immunology and Rheumatology
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Sponsor website:
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http://www.amc.uva.nl/#http://www.amc.uva.nl/
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Date applied
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16/01/2007
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Last edited
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23/02/2011
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Date ISRCTN assigned
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16/01/2007
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