NCT01782235

Brief Summary

Primary Sjögren's syndrome (pSS) is a systemic autoimmune disease characterized by lymphocytic infiltration leading to destruction of acinar and ductal cells and loss of glandular parenchyma. The main symptoms of pSS are dry eyes and dry mouth, diffuse pain, and fatigue. One third of patients develop systemic features, the most severe being lymphomas. Serum IL-6 is increased in serum, saliva, and tears of patients with pSS. IL-6 plays a pivotal role in B-cell activation, a hallmark of the pathogenesis of pSS, and in T-cell differentiation. Tocilizumab, a recombinant humanised monoclonal antibody acts as an IL-6R antagonist. The aim of this randomised double blind placebo controlled trial iss to evaluate the efficacy of tocilizumab for the treatment of pSS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

July 24, 2013

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2018

Completed
Last Updated

January 20, 2026

Status Verified

January 1, 2026

Enrollment Period

5 years

First QC Date

January 30, 2013

Last Update Submit

January 16, 2026

Conditions

Primary Sjögren's Syndrome (pSS)

Outcome Measures

Primary Outcomes (1)

  • Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment.

    Improvement of the ESSDAI score equal to or greater than 3 points compared to enrollment, with no new domain with high activity of the ESSDAI compared to enrollment, and no clinical worsening according to the clinician (no worsening compared to enrollment greater than 1 point of the Systemic Activity 0-10 VAS according to the physician.

    24 weeks

Study Arms (2)

Tocilizumab arm

EXPERIMENTAL

Tocilizumab arm will receive tocilizumab.

Drug: Tocilizumab

Placebo arm

PLACEBO COMPARATOR

Placebo arm will receive placebo.

Drug: Placebo

Interventions

TocilizumabDRUG
Tocilizumab arm
PlaceboDRUG
Placebo arm

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient with previous history of therapy with tocilizumab.
  • A prednisone dose ≥ 15 mg per day.
  • 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 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.
  • Neutropenia \< 1000\*10\^6 .
  • Thrombocytopenia \< 50 000/µl
  • ALT or AST \> 3 x ULN
  • Pregnant woman, breast feeding woman
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

Related Publications (1)

  • Felten R, Devauchelle-Pensec V, Seror R, Duffau P, Saadoun D, Hachulla E, Pierre Yves H, Salliot C, Perdriger A, Morel J, Mekinian A, Vittecoq O, Berthelot JM, Dernis E, Le Guern V, Dieude P, Larroche C, Richez C, Martin T, Zarnitsky C, Blaison G, Kieffer P, Maurier F, Dellal A, Rist S, Andres E, Contis A, Chatelus E, Sordet C, Sibilia J, Arnold C, Tawk MY, Aberkane O, Holterbach L, Cacoub P, Saraux A, Mariette X, Meyer N, Gottenberg JE. Interleukin 6 receptor inhibition in primary Sjogren syndrome: a multicentre double-blind randomised placebo-controlled trial. Ann Rheum Dis. 2021 Mar;80(3):329-338. doi: 10.1136/annrheumdis-2020-218467. Epub 2020 Nov 18.

    PMID: 33208345RESULT

MeSH Terms

Interventions

tocilizumab

Study Officials

  • Jacques-Eric Gottenberg

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2013

First Posted

February 1, 2013

Study Start

July 24, 2013

Primary Completion

July 16, 2018

Study Completion

July 16, 2018

Last Updated

January 20, 2026

Record last verified: 2026-01

Locations

FR(1)