EUCTR2011-000699-32-BE
Active, not recruiting
Not Applicable
ail involvement in psoriatic arthritis: a cross-sectional and observational prospective study. - NIPA
Z KULeuven, service of Rheumatology0 sitesMay 18, 2011
DrugsRemicade
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Z KULeuven, service of Rheumatology
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\-PsA patients must meet the CASPAR criteria
- •\-Psoriasis patients must meet criteria for psoriasis
- •\-RA patients must meet the 1987 revised ACR criteria for RA
- •\-Hand OA patients must meet the ACR criteria for hand OA.
- •\-Healthy controls
- •\-Diagnosis of psoriatic arthritis fulfilling the CASPAR criteria
- •\-Polyarticular disease (\> 5 joints)
- •\-Active arthritis in at least 5 joints
- •\-Active disease despite adequate methotrexate treatment.
- •\-Health Assesment Questionnaire index of 25%.
Exclusion Criteria
- •1\. in the psoriasis group: patients with a history of or active joint disease
- •2\. In the RA en OA groep: patients with psoriasis or a history hereof and with other nail diseases
- •3\. In the healthy control group: presence or history of psoriasis or nail diseases.
- •1\. Previous or current use of anti\-TNF therapy or any other biologic.
- •2\. Current use of cyclosporine or leflunomide.
- •3\. If patients are using methotrexate, they must be on a stable dose for at least 3 months to be included in the study.
- •4\. If patients are using corticosteroids, they must remain on a stable dose for at least 3 months of 10 mg or less of prednisolone (or equivalent) to be included in the study.
- •5\. Nail or finger steroid applications including nail bed injections are forbidden during the study.
- •6\. Treatment with UVA/PUVA, nitroglyceride ointment as well as cyclosporin or new biologics for psoriasis are not permitted.
- •7\. Women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion (this includes father's who plan on fathering a child within 6 months after their last infusion).
Outcomes
Primary Outcomes
Not specified
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