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 |
| Secondary identifying numbers | N/A |
- Submission date
- 16/01/2007
- Registration date
- 16/01/2007
- Last edited
- 08/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Skin and Connective Tissue Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A W R van Kuijk
Scientific
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 |
|---|---|
| a.w.vankuijk@amc.uva.nl |
Study information
| Study design | Randomised placebo-controlled parallel-group double-blinded trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Adalimumab |
| Primary outcome measure | 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 study start date | 01/02/2006 |
| Completion date | 01/05/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center (AMC)
Amsterdam
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Center (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Division of Clinical Immunology and Rheumatology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
| Website | http://www.amc.uva.nl/#http://www.amc.uva.nl/ |
|---|---|
"ROR" |
https://ror.org/03t4gr691 |
Funders
Funder type
Hospital/treatment centre
Academisch Medisch Centrum (AMC) (Netherlands)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- Academic Medical Center, AMC
- Location
- Netherlands
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| 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 |
Editorial Notes
08/04/2016: Publication reference added.
