Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Could an arthritis drug ease Sjögren's symptoms?

NCT ID NCT01782235

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

110 people

The number who actually took part.

Started

Jul 2013

Finished

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

18 to 80 years

Sex

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

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Primary Sjögren's syndrome (PSS) are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67098, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.