To find out the dynamics of cell biological changes in lesional skin during treatment with adalimumab. Secondary objectives:- To find out whether adalimumab treatment results in (1) a reduction of T cell subsets, (2) normalization of proliferation…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The PASI score at all visits.
Cell biological parameters in the punch biopsies for T cells, innate immunity
and epidermal proliferation.
Secondary outcome
Not applicable.
Background summary
During effective antipsoriatic treatment virtually all abnormalities in the
psoriatic lesion improve. However, it is feasible that some changes are
mandatory for a clinical effect as a *conditio sine qua non* and other changes
are just the result of the improvement. The study is an attempt to find out
whether some abnormalities normalize before clinical improvement and may have a
predictive effect.
Study objective
To find out the dynamics of cell biological changes in lesional skin during
treatment with adalimumab.
Secondary objectives:
- To find out whether adalimumab treatment results in
(1) a reduction of T cell subsets,
(2) normalization of proliferation and differentiation characteristics and
(3) a reduction of parameters for innate immunity
- To find out the order in which the above mentioned parameters show an
alteration.
- To correlate the alteration of cell biological parameters with clinical
improvement.
The hypothesis is that certain cell biological parameters normalize before
clinical improvement and that improvement of such a parameter is mandatory and
predictive for clinical efficacy.
Study design
An observational open label study with invasive measures.
Study burden and risks
The 10 patients will treated with adalimumab for reason that there are clinical
indications for treatment selection before the decision as to participate in
the study will be made. The biopsies of the skin (6 in total) heal with only a
minimal chance of scar formation. The benefit for the patient is that which can
be expected form the standard treatment with adalimumab. A further insight in
the mode of action is what the investigators expect from this study.
Postbus 9101
6500 HB Nijmegen
NL
Postbus 9101
6500 HB Nijmegen
NL
Listed location countries
Age
Inclusion criteria
Subjects 18 years of age or older who have moderate to severe plaque psoriasis, as defined by PASI score >= 10 or PASI score >= 8 AND Skindex total score > 35 at the baseline (week 0) visit. Patients have failed, are intolerant or have contraindications to methotrexate, PUVA and cyclosporin.
Exclusion criteria
- Known history of allergic reaction or significant hypersensitivity to the constituents of adalimumab.
- Systemic therapy for psoriasis for at least 4 weeks prior to Baseline; except for biologic therapies which must be discontinued at least 12 weeks prior to enrolment.
- Topical psoriasis therapy for at least 2 weeks prior to Baseline, except for non-corticosteroid shampoos, bland emollients and low potency topical corticosteroids on the palms, soles, face, inframammary area, and groin only.
- Use of PUVA for at least 4 weeks prior to Baseline.
- Use of oral or injectable corticosteroids for at least 4 weeks prior to Baseline and during the study.
- Use of medication which may aggravate psoriasis: β blockers, antimalaria drugs, NSAID and lithium carbonate.
- Use of tanning beds, excessive sun exposure, or phototherapy (UVB, UVA), for at least 2 weeks prior to Baseline.
- Other active skin diseases or skin infections (bacterial, viral or fungal) that may interfere with evaluation of psoriasis.
- History of listeriosis, histoplasmosis, untreated TB, persistent chronic infections.
- Recent active infections requiring hospitalization or treatment with intravenous (IV) anti-infectives within 30 days or oral anti-infectives within 14 days prior to the Baseline visit.
- Immune deficiency, history of HIV or is immunocompromised.
- Use of anti-retroviral therapy.
- Positive Hepatitis B or C (previous infection).
- History of neurologic symptoms suggestive of central nervous system demyelinating disease.
- Malignancies other than successfully treated non-metastatic cutaneous squamous cell of basal cell carcinoma, or cervical carcinoma in situ.
- Erythrodermic, generalized pustule, new onset guttate, or medication-related or exacerbated psoriasis vulgaris.
- Subject has a poorly controlled medical condition.
- Female subject who is pregnant or breast-feeding or has positive serum pregnancy test at screening or considering becoming pregnant during the study or within 5 months after the last dose of adalimumab.
- History of keloid formation following wounding.
- Investigator considers the subject unsuitable for adalimumab for any reason.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-001952-32-NL |
| CCMO | NL22745.091.08 |