A prospective study for the effects of treatment with adalimumab in patients with psoriasis and psoriatic arthritis

Not Applicable

Completed

• Conditions: Psoriatic arthritis, psoriasis; Skin and Connective Tissue Diseases; Psoriasis

• Registration Number: ISRCTN23328456
• Lead Sponsor: Academic Medical Center (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-16
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 24

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).