EUCTR2006-000854-32-AT
Active, not recruiting
Not Applicable
Rituximab in Rheumatoid Arthritis in Patients Who Failed Therapy With TNF-Blockers
Vienna Medical University0 sites20 target enrollmentStarted: May 19, 2006Last updated:
DrugsRituximab - MabThera
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Vienna Medical University
- Enrollment
- 20
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria
- •\-Women or men 18 years of age or older
- •\-Diagnosis of RA according to the revised 1987 criteria of the ARA (5\) for at least 3 months prior to first administration of study medication
- •\-The current treatment with Etanercept, Infliximab or Adalimumab in combination with MTX is insufficient. The patient’s disease is considered to be active despite DMARD treatment.
- •\-Active disease at the time of screening as defined by:
- •o\= 6 swollen on a 66/68 joint count
- •o\= 6 tender joints on a 66/68 joint count
- •oand one out of the following 3 categories
- •?ESR \= 28 mm/ h
- •?CRP \= 1\.5 mg/ dl
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 IM, IV, IA cortocisteroids within 4 weeks prior to screening.
- •\-Treatment with any investigational drug within 3 months prior to screening.
- •\-A history of known allergy to murine proteins, e.g. allergy to Infliximab
- •\-History of infected joint prothesis within the previous 5 years
- •\-Chronic infections
Investigators
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