Skip to content

Onderzoek naar de samenstelling van afweercellen in Psoriasis Artritis en Psoriasis.

T cell receptor profiling in psoriatic arthritis.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON25716
Enrollment
60
Registered
2009-08-17
Start date
2009-01-10
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriatic arthritis T-cell Antigen receptor

Interventions

This is a comparative study where we investigate the differences in the T-cel receptor profile in PsA patients and psoriasis patients and we study the effects of standard therapy on pathogenic T-cells
From each patient of the PsA group 40ml heparinised peripheral blood, two 4mm biopsies of non-involved buttock skin and 2 biopsies of 4 mm of the involved psoriatic skin, and 20 biopsies of 2 mm of t

Sponsors

Erasmus Medical Centre Department of Dermatology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: PsA group: Adults patients (18-75 years of age, after informed consent), with joint inflammation of one or both knees due to PsA requiring systemic treatment. The patients have failed to respond to, or have a contraindication for cyclosporine and other DMARDS except MTX. Psoriasis group: Adult patients (18-75 years of age, after informed consent) that have psoriasis with a Psoriasis Area and Severity Index (PASI) ¡Ý 10 and/or Body Surface Area (BSA) ¡Ý 10 and/or PASI¡Ý 8 together with skindex ¡Ý 35, that have only psoriasis in their history for at least 10 years, no signs of joint inflammation and that require systemic treatment. The patients have failed to respond to, or have a contraindication for cyclosporine and other DMARDS expect MTX.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation; 2. Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis; 3. Malignancy in last 10 years, except BCC and cervical in situ cancer; 4. Treatment of etanercept stopped because of inefficacy, contraindication or serious adverse events, after etanercept therapy for minimal 12 weeks; 5. Demyelinating disease; 6. Congestive heart failure; 7. Allergies and hypersensitivities to potential anti-rheumatic drugs or their ingredients; 8. Any live virus or bacterial vaccination within 3 months; 9. Severe liver function disorders >2 times and/or kidney function disorders >1,5 times upper limits of the reference values.

Design outcomes

Primary

MeasureTime frame
1. The difference(s) in T-cell receptor (TCR-G) profile between psoriatic skin lesions and inflamed knee joint in PsA patients; 2. The difference(s) in T-cell receptor (TCR-G) profile between psoriatic skin lesions in psoriasis patients and psoriatic skin lesions in PsA patients; 3. The difference(s) in T cell gene expression profile from psoriatic skin lesions in psoriasis patients and psoriatic skin lesions of PsA patients; 4. Gene expression profile of T cells from inflamed knee joint of PsA patients.

Secondary

MeasureTime frame
Effects of therapy on pathogenic T cells and their gene expression profile in PsA and psoriasis.

Contacts

Public ContactL.A. Torcque

Department of Dermatology and Venereology Erasmus MC pobox 2040

l.a.torcque@erasmusmc.nl+31 (0)10-7043190

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)