To investigate whether the T cell profile of T cells in inflamed skin of psoriasis patients is identical or not to inflamedskin/synovium in psoriatic arthritis patients . All this in comparison to healthy controls. By determining the clonality and…
ID
Source
Brief title
Condition
- Epidermal and dermal conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Typing of pathogenic T cell population in skin an joints;
1.T-cell receptor (TCR-G) profile.
2.Gene expression profile.
Secondary outcome
1.Effects of anti-arthritic therapy on pathogenic T cells.
Background summary
Patients with psoriatic arthritis (PsA) suffer from both chronic joint and skin
inflammation, resulting in a greatly reduced quality of life. Approximately 30%
of patients with psoriasis will develop arthritis. However, sometimes skin
signs precede arthritis and vice versa, arthritis may precede skin lesions for
many years. Till today one cannot predict which patient with psoriasis will
develop arthritis or not, since predictive tests are not available. It is known
that the immune system and especially T cells play a major role in the
pathogenesis of both arthritis and of psoriasis. However the exact phenotype
and functional role of T cells that mediate inflammation in the skin and in the
joints remain unclear.Treatment of PsA consists of DMARDs (disease-modifying
antirheumatic drugs) that in some cases aren*t effective or whish the patient
can not tolerate. In such cases treatment with biologicals is indicated .
Study objective
To investigate whether the T cell profile of T cells in inflamed skin of
psoriasis patients is identical or not to inflamedskin/synovium in psoriatic
arthritis patients . All this in comparison to healthy controls. By
determining the clonality and the genetic profile of the T cells in inflamed
tissue, a pathogenic T cell population may be identified. The results of this
study will help predict which patient with psoriasis will develop arthritis and
which patient not. Or which patient with arthritis will develop psoriasis and
which patient not.
Secondary objective; To investigate whether the pathogenic T-cells in inflamed
joints of PsA patients are effectively reduced after standard anti-arthritic
therapies.
Study design
A comparative study, whereby T cells isolated from PsA joints and psoriasis
lesions will be analysed and compared with the T cell receptor profile of T
cells from psoriasis skin lesions of patients without arthritis.
Study burden and risks
The results of this study could help other patients to be diagnosed in an early
stage, to discriminate whether they are affected with psoriasis or psoriatic
arthritis. So appropriate therapy can be given before lesions become disabling.
The benefit for the patient could be an improvement or prevention of the
psoriasis plaques and further joint inflammation by early treatment.
Patients will not experience higher risks when treated for PsA or psoriasis in
this study, because the treatment they receive is according to current
standards guidelines.
Synovial biopsies are routinely taken as a diagnostic procedure [8, 9]. Also
for research purposes synovial biopsies are taken in the MEC-approved REACH
study of the department of rheumatology of the Erasmus MC. Risks or
complications that can occur after taking biopsies from knee or skin are
possible bacterial infections, a bleeding at the location where the biopsy is
taken or technical problems with the biopsy tool. There are no studies that
show how big these risks are after a knee biopsy, but as a reference: an
experienced rheumatologist knows that every year 1500 synovial biopsies are
taken in the Netherlands and complications are rarely seen.
PO BOX 2040
3000 CA Amsterdam
NL
PO BOX 2040
3000 CA Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Psoriatic Arthritis group;
1.Age; 18-75 years
2.Joint inflammation of one or both knees due psoriatic artritis.
3.Patients require systemic treatment.
4.have failed to respond to, or have a contraindication for cyclosporine and other DMARDS exept MTX.;Psoriasis group;
1.Age; 18-75 years
2.Patients have psoriasis and a severity index (PASI) of 10 or more then 10 and/or Body Surface Area (BSA) of 10 or more then 10 and/or PASI of 8 or less then 8 together with skindex of 35 or more then 35.
3. Patients have psoriasis in their history for at least 10 years.
4. Patients have no signs of joint inflammation, nor in their history.
5.Patients require systemic treatment.
6.Patients have failed to respond to, or have a contraindication for cyclosporine and other DMARDS exept MTX.
Exclusion criteria
Pregnancy and lactation- active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis- Malignancy in last 10 years, exept BCC and cervical insitu cancer- treatment with a biological stopped because of inefficacy, contraindication or serious adverse events, after biological therapy for minimal 12 weeks-demyelinating disease-congestive heart failure-allergies and hypersensitivities to potential anti-rheumatic drugs or their ingredients-any live virus or bacterial vaccination within 3 months- severe liver function disorders > 2 timesand/or kidney function disorders > 1,5 times upper limits of the reference values.
Design
Recruitment
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 |
|---|---|
| CCMO | NL29535.078.09 |