Could an arthritis drug ease Sjögren's symptoms?
NCT ID NCT01782235
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether tocilizumab, a drug that blocks inflammation, can help people with primary Sjögren's syndrome—an autoimmune disease causing dry eyes, dry mouth, pain, and fatigue. Researchers gave 110 participants either tocilizumab or a placebo to see if it could reduce disease activity. The goal was to find a new treatment option for this chronic condition.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tocilizumab (a drug that blocks IL-6, a protein involved in inflammation)
- What this could lead to
- If successful, this could point toward a new treatment option to control disease activity and improve symptoms in people with primary Sjögren's syndrome.
- What could go wrong
- This is a completed Phase 2/3 trial, but results may not show significant benefit over placebo. Tocilizumab also carries risks like infection, and not all patients may respond.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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110 people
The number who actually took part.
- Started
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Jul 2013
- Finished
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Jul 2018
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Hôpitaux Universitaires de Strasbourg
Strasbourg, 67098, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.