A randomised double blind placebo controlled clinical trial of anti B-cell therapy in patients with primary Sjögren’s syndrome. - TRACTISS (Rituximab / Placebo in Sjogren's Syndrome) Version 1.0

niversity of Leeds0 sites110 target enrollmentNovember 4, 2010

ConditionsPrimary Sjögren’s syndrome (PSS).MedDRA version: 14.1Level: PTClassification code 10040767Term: Sjogren's syndromeSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsMabThera (rituximab)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Primary Sjögren’s syndrome (PSS).
Sponsor: niversity of Leeds
Enrollment: 110
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 4, 2010

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity of Leeds

Eligibility Criteria

Inclusion Criteria

•Eligibility waivers to inclusion/exclusion criteria are not permitted.
•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:
•Hypergammaglobulinaemia (IgG over 16\)\*, or
•Low complement C4\*, or
•Cryoglobulinaemia
•Active/past history since diagnosis of the following (ascribed to Sjögren’s Syndrome):
•opurpura/cutaneous vasculitis,

Exclusion Criteria

•Patients will be excluded from the trial for the following reasons:
•1\.Diagnosis of secondary Sjögren’s syndrome.
•2\.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.
•3\.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.
•4\.Patient has active or prior hepatitis B or C, known HIV positivity or known history of tuberculosis.
•5\.Immunodeficiency or neutropaenia \<1\.5 x 109/l (unless a diagnosis of benign ethnic neutropaenia has been confirmed in which case the neutrophil count must be \> 0\.9 x 109/l at screening for Jamaican and Afro\-Caribbean populations (60\)).
•6\.Any AECG exclusion criteria not covered elsewhere (graft versus host disease, primary lymphoma excluding PSS, sarcoidosis).
•7\.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)
•8\.Participation in a clinical study involving administration of an investigational drug within the past 4 weeks prior to the first infusion.
•9\.A history of major surgery within 3 months prior to first infusion or planned surgery during the study.