Differential effect of adalumimab versus etanercept on apoptosis in the psoriatic ski

Completed

• Conditions: arthritis psoriatica; 10003816; 10023213; 10040790

• Registration Number: NL-OMON30655
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Man and woman older than 18 year en younger than 75 year
2. Diagnosis of Psoriatic arthritis with involvement of the peripheral joints
3. Failure on etanercept therapy as measured by PASI and DAS
4. Indication for treatment with etanercept according to the LABAG guidelines
5. Active disease despite treatment with methotrexate and etanercept, MTX >_ 15 mg/wk in a stable dosis during 3 months; still active skin lesions despite MTX and etanercept treatment
5. Corticosteroids (max 10 mg/day) en NSAID*s stable dose.
6. Signed informed consent.

Exclusion Criteria

1. Rheumatoid arthritis and/or other autoimmune diseases
2. Pregnancy / breastfeeding.
3. TBC/ hepatitis b or c or other chronic infections.
4. Contraindications for TNF-alpha like a malignancy or a chronic demyelinating disease.
5. No participation in another study.
6. No PUVA or vitamine D treatment during 1 month before and during the study.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary<br /><br>1. Amount of apoptotic cells<br /><br>2. Evaluation of cellular infiltrates</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary<br /><br>1. Clinical improvement; DAS response criteria, PASI skin score.</p><br>