Contact information
Type
Scientific
Primary contact
Dr A W R van Kuijk
ORCID ID
Contact details
Academic Medical Center (AMC)
Division of Clinical Immunology and Rheumatology
F4-218
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
+31 (0)20 566 2171
a.w.vankuijk@amc.uva.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis
Acronym
ADAPs
Study hypothesis
Find the best predictive biomarker for response to treatment.
Ethics approval
Medical Ethical Committee of the Academic Medical Centre/University of Amsterdam, 10/08/2005, ref: MEC 05/162
Study design
Randomised placebo-controlled parallel-group double-blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Psoriatic arthritis, psoriasis
Intervention
Adalimumab 40 mg or placebo once every other week subcutaneous (first four weeks), open label adalimumab 40 mg after week four.
Intervention type
Drug
Phase
Not Specified
Drug names
Adalimumab
Primary outcome measures
Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week four compared to baseline.
Secondary outcome measures
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).
Overall trial start date
01/02/2006
Overall trial end date
01/05/2007
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
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
Recruitment start date
01/02/2006
Recruitment end date
01/05/2007
Locations
Countries of recruitment
Netherlands
Trial participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Center (AMC) (Netherlands)
Sponsor details
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Academisch Medisch Centrum (AMC) (Netherlands)
Alternative name(s)
Academic Medical Center, AMC
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
Netherlands
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20844595
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/25187158
Publication citations
-
Results
van Kuijk AW, DeGroot J, Koeman RC, Sakkee N, Baeten DL, Gerlag DM, Tak PP, Soluble biomarkers of cartilage and bone metabolism in early proof of concept trials in psoriatic arthritis: effects of adalimumab versus placebo., PLoS ONE, 2010, 5, 9, doi: 10.1371/journal.pone.0012556.
-
Results
Ademowo OS, Hernandez B, Collins E, Rooney C, Fearon U, van Kuijk AW, Tak PP, Gerlag DM, FitzGerald O, Pennington SR, Discovery and confirmation of a protein biomarker panel with potential to predict response to biological therapy in psoriatic arthritis, Ann Rheum Dis, 2016, 75, 1, 234-241, doi: 10.1136/annrheumdis-2014-205417.