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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2014 by University Hospital, Strasbourg, France.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University Hospital, Strasbourg, France Identifier:
First received: January 30, 2013
Last updated: March 11, 2014
Last verified: March 2014

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.

Condition Intervention Phase
Primary Sjögren's Syndrome (pSS) Drug: Tocilizumab Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.

Resource links provided by NLM:

Further study details as provided by University Hospital, Strasbourg, France:

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

Estimated Enrollment: 110
Study Start Date: July 2013
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tocilizumab arm
Tocilizumab arm will receive tocilizumab.
Drug: Tocilizumab
Placebo Comparator: Placebo arm
Placebo arm will receive placebo.
Drug: Placebo


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria :

  • Patient with primary Sjögren's syndrome according to the European - American consensus group criteria.
  • Presence of anti SSA (Ro) or of anti-SSA and anti-SSB(La) antibodies
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01782235

Contact: Jacques-Eric GOTTENBERG 3 88 12 81 89 ext 0033

Hôpitaux Universitaires de Strasbourg Recruiting
Strasbourg, France, 67098
Contact: Jacques-Eric Gottenberg    3 88 12 81 89 ext 0033   
Principal Investigator: Jacques-Eric Gottenberg         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Jacques-Eric Gottenberg Hôpitaux Universitaires de Strasbourg
  More Information

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT01782235     History of Changes
Other Study ID Numbers: 5206
2012-002045-37 ( EudraCT Number )
Study First Received: January 30, 2013
Last Updated: March 11, 2014

Additional relevant MeSH terms:
Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases processed this record on September 21, 2017