Condition category
Skin and Connective Tissue Diseases
Date applied
16/01/2007
Date assigned
16/01/2007
Last edited
08/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.amc.uva.nl/#http://www.amc.uva.nl/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes

08/04/2016: Publication reference added.