Efficacy of Tocilizumab in Primary Sjögren's Syndrome.

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01782235
• Date of registration: 30/01/2013
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Strasbourg, France
• Public title: Efficacy of Tocilizumab in Primary Sjögren's Syndrome. ETAP
• Scientific title: A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.
• Date of first enrolment: July 24, 2013
• Target sample size: 110
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01782235
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2/Phase 3

Countries of recruitment

France

Contacts

• Name: Jacques-Eric Gottenberg
• Affiliation: Hôpitaux Universitaires de Strasbourg

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjögren's Syndrome (pSS)

Intervention(s)

Drug: Tocilizumab

Drug: Placebo

Primary Outcome(s)

Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment. [Time Frame: 24 weeks]

Secondary ID(s)

2012-002045-37

5206

Source(s) of Monetary Support

Please refer to primary and secondary sponsors