EUCTR2006-004673-98-HU
Active, not recruiting
Not Applicable
Efficacy of Rituximab treatment in patients with rheumatoid arthritis having inadequate response to TNF blocker
Roche (Hungary) Ltd.0 sites20 target enrollmentSeptember 8, 2006
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- To investigate the efficacy of treatment with Rituximab (MabThera®) in patients with active RA whose current treatment with one or more TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalimumab - Humira®) alone or in combination with MTX is insufficient measured by DAS28 activity index.
- Sponsor
- Roche (Hungary) Ltd.
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women or men 18 years of age or older
- •Diagnosis of RA according to the revised 1987 criteria of the ARA for at least 3 months prior to first administration of study medication
- •Inadequate response or intolerance to one or more anti\-TNF\-therapies alone or in combination with MTX
- •Wash out period for anti\-TNF therapies: 4 weeks for etanercept, 8 weeks for infliximab and for adalimumab
- •Active disease at the time of screening as defined by:
- •\- \= 6 swollen on a 66/68 joint count
- •\- \= 6 tender joints on a 66/68 joint count
- •And one out of the following 3 categories:
- •\- ESR \= 28 mm/ h
- •\- CRP \= 1\.5 mg/ dl
Exclusion 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 RA.
- •Severe heart failure ( NYHA class IV) or severe, uncontrolled cardiac disease
- •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.
- •Known active bacterial, viral, fungal, mycobacterial or other infection (including tuberculosis, or atypical mycobacterial disease, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
Outcomes
Primary Outcomes
Not specified
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