A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis

ISRCTN	ISRCTN23328456
DOI	https://doi.org/10.1186/ISRCTN23328456
Protocol serial number	N/A
Sponsor	Academic Medical Center (AMC) (Netherlands)
Funder	Academisch Medisch Centrum (AMC) (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr A W R van Kuijk
Scientific

Academic Medical Center (AMC)
Division of Clinical Immunology and Rheumatology, F4-218
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Phone	+31 (0)20 566 2171
Email	a.w.vankuijk@amc.uva.nl

Primary study design	Interventional
Study design	Randomised placebo-controlled parallel-group double-blinded trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis
Study acronym	ADAPs
Study objectives	Find the best predictive biomarker for response to treatment.
Ethics approval(s)	Medical Ethical Committee of the Academic Medical Centre/University of Amsterdam, 10/08/2005, ref: MEC 05/162
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Adalimumab
Primary outcome measure(s)	Changes in cellular infiltrate and cytokine expression, measured by immunohistochemical analysis, in biopsies of skin and synovium at week four compared to baseline.
Key secondary outcome measure(s)	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).
Completion date	01/05/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	24
Key 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
Key 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
Date of first enrolment	01/02/2006
Date of final enrolment	01/05/2007

Academic Medical Center (AMC)

Amsterdam
1100 DD
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/09/2010		Yes	No
Results article	results	01/01/2016		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

08/04/2016: Publication reference added.