ISRCTN65360827
Completed
Phase 3
A randomised double blind placebo controlled clinical trial of anti-B-cell therapy in patients with primary Sjögren's syndrome
niversity of Leeds (UK)0 sites110 target enrollmentJuly 9, 2010
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversity of Leeds (UK)
- Enrollment
- 110
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Current inclusion criteria as of 20/09/2011:
- •1\. Aged between 18 and 80 years of age.
- •2\. A confirmed diagnosis of primary Sjögren?s syndrome by AECG criteria (see Appendix B).
- •3\. Positive for anti\-Ro auto\-antibodies.
- •4\. Patients with a diagnosis of primary Sjögren?s syndrome (by AECG criteria) with more than 10 years disease duration must have at least one systemic feature of:
- •4\.1 Hypergammaglobulinaemia (IgG over 16\)\*, or
- •4\.2 Low complement C4\*, or
- •4\.3 Cryoglobulinaemia
- •4\.4 Active/past history since diagnosis of the following (ascribed to Sjögren?s Syndrome):
- •4\.5 purpura/cutaneous vasculitis,
Exclusion Criteria
- •Current exclusion criteria as of 20/09/2011:
- •1\. Diagnosis of secondary Sjögren?s syndrome.
- •2\. Use of DMARDs, immunosuppressant therapies or antidepressants within 4 weeks prior to the first dose administration (except for glucocorticoids, salicylates, non\-steroidal anti inflammatory drugs (NSAIDs), methotrexate and analgesics which are acceptable).
- •3\. Pregnancy, lactation or women of child\-bearing potential (WCBP) unwilling to use medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
- •4\. Men whose partners are of child\-bearing potential but who are unwilling to use appropriate medically approved contraception whilst receiving treatment and for 12 months after treatment has finished.
- •5\. Patient has active or prior hepatitis B or C, known HIV positivity or known history of tuberculosis.
- •6\. Any history of other autoimmune diseases or other form of immunodeficiency or neutropaenia \<1\.5 109/l.
- •7\. Any AECG exclusion criteria not covered elsewhere (graft versus host disease, primary lymphoma excluding PSS, sarcoidosis).
- •8\. Any malignancies that would normally preclude the use of rituximab within the past 5 years, including solid tumours, haematological malignancies and carcinoma in situ (except basal cell or squamous cell carcinoma of the skin that has been excised and cured)
- •9\. Participation in a clinical study involving administration of an investigational drug within the past 4 weeks prior to the first infusion.
Outcomes
Primary Outcomes
Not specified
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