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Clinical Trials/EUCTR2011-000699-32-BE
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

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.

Registry
who.int
Start Date
May 18, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Z KULeuven, service of Rheumatology

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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