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Clinical Trials/EUCTR2006-000844-17-SK
EUCTR2006-000844-17-SK
Active, not recruiting
Phase 1

A multi-centre pilot study of Rituximab in patients with active PsA

Vienna Medical University0 sites30 target enrollmentSeptember 10, 2009
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DrugsMabThera

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Vienna Medical University
Enrollment
30
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 10, 2009
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Vienna Medical University

Eligibility Criteria

Inclusion Criteria

  • •Inclusion criteria
  • •\-Patients diagnosed with PsA according to the following criteria: Psoriasis or family history of psoriasis plus any one of the following criteria: clinical inflammatory enthesitis, radiographic enthesitis, distal interphalangeal joint disease, sacroiliitis or spinal inflammation, uncommon arthropathies (SAPHO, spondylodiscitis, arthritis mutilans, onchyo\-pachydermo\-periostitis, chronic multifocal recurrent osteomyelitis), dactylitis, monoarthritis, oligoarthritis (four or less swollen joints) (7\)
  • •\-Age \= 18 years
  • •\-Negative rheumatoid factor
  • •\-The disease should at least have been diagnosed 6 months prior to screening
  • •\-Active disease at the time of screening as defined by
  • •o2 out of the following 3 criteria:
  • •?\= 4 swollen on a 66/68 joint count
  • •?\= 4 tender joints on a 66/68 joint count
  • •?Presence of dactylitis

Exclusion Criteria

  • •Exclusion criteria
  • •Patients are excluded if they meet one of the following criteria:
  • •\-Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment
  • •\-Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
  • •\-Patients with fibromyalgia syndrome
  • •\-Use of Rituximab prior to screening
  • •\-Use of IM, IV, IA, cortocisteroids within 4 weeks prior to screening
  • •\-Treatment with any investigational drug within 3 months prior to screening
  • •\-Use of cyclosporine or tacrolimus within 4 weeks prior to screening
  • •\-A history of known allergy to murine proteins, e.g. allergy to Infliximab

Outcomes

Primary Outcomes

Not specified

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