Efficacy of Tocilizumab in Primary Sjögren's Syndrome. (ETAP)

This is an interventional treatment trial for Primary Sjögren's Syndrome (pSS) Read More

Inclusion Criteria :

• Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
• ESSDAI score ≥ 5.
• In women in childbearing age, effective contraception during treatment and 3 months following treatment discontinuation.

Exclusion Criteria:

• Patient with previous history of therapy with tocilizumab.
• Prednisone treatment introduced two weeks before inclusion or a change in this drug dose within two weeks before inclusion.
• A prednisone dose ≥ 15 mg per day.
• Non-steroidal anti-inflammatory drugs, pilocarpine hydrochloride, cyclosporine, cimeviline if introduced within two weeks before inclusion.
• Therapy with methotrexate, Hydroxychloroquine, chloroquine, quinacrine, leflunomide, psychoactive drug if introduced within 8 weeks before inclusion or a dose change within 8 weeks before inclusion.
• Treatment with azathioprine or mycophenolate mofetil within 8 weeks before inclusion.
• Live and live attenuated vaccines given within 4 weeks before inclusion.
• Any biologic treatment within 6 month before inclusion.
• Treatment with cyclophosphamide, intravenous immunoglobulin therapy or plasmapharese therapy in the last 6 months before inclusion.
• Systemic auto-immune disease.
• Patient with previous history of diverticular perforations, complications of diverticulitis, peritonite or inflammatory bowel disease (such as Crohn's disease and Colitis ulcerative).
• Patient with history of severe infection within 4 weeks before inclusion.
• Patient with history of infection within 2 weeks before inclusion.
• Patient with chronic infection or infection returns (e.g. tuberculose, VHB, VHC…).
• Positive serology tests for HIV, HBV, HCV.
• Severe uncontrolled dyslipidemia.
• Hepatocellular insufficiency.
• Unstable cardiovascular disease.
• Severe or chronic kidney disease, severe or chronic lung disease, severe or chronic endocrine disorder, severe or chronic neurological disease ( not related to the SJP).
• Patient with history of solid organ transplantation or haematopoietic stem cell transplantation.
• Patient with history of lymphoma, neoplasia diagnosed 5 years before inclusion except squamous and basal cell cancers and carcinoma in situ of the uterine cervix.
• Severe complications of SJp at the inclusion: vasculitis with renal neurologic, digestive or cardiac involvement, interstitial lung disease, symptomatic cryoglobulinemia with severe neurologic involvement, renal function impairment, severe myositis, corticotherapy ≥ 1 mg/kg in the last 30 days before inclusion.
• Neutropenia < 1000*10^6 .
• Thrombocytopenia < 50 000/µl
• ALT or AST > 3 x ULN
• alcohol and drug addiction : withdrawal at least one year before inclusion
• A major surgical procedure in the 8 weeks before inclusion or a scheduled major surgery
• Pregnant woman, breast feeding woman
• Adults under supervision or guardianship
• Patient taking part in another clinical trial