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

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ClinicalTrials.gov Identifier: NCT01782235
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE January 30, 2013
First Posted Date  ICMJE February 1, 2013
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE July 24, 2013
Actual Primary Completion Date July 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2013)
Proportion of patient with an enhancement superior or equal to 30% of the ESSPRI (EULAR Sjogren's Syndrome Patient Reported Index) score. [ Time Frame: 28 weeks ]
Change History Complete list of historical versions of study NCT01782235 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tocilizumab in Primary Sjögren's Syndrome.
Official Title  ICMJE A Randomized, Double-blind, Parallel, Placebo-controlled Trial to Evaluate the Efficacy of Tocilizumab for the Treatment of Primary Sjögren's Syndrome.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Primary Sjögren's Syndrome (pSS)
Intervention  ICMJE
  • Drug: Tocilizumab
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: Tocilizumab arm
    Tocilizumab arm will receive tocilizumab.
    Intervention: Drug: Tocilizumab
  • Placebo Comparator: Placebo arm
    Placebo arm will receive placebo.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 11, 2014)
110
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2013)
80
Actual Study Completion Date  ICMJE July 16, 2018
Actual Primary Completion Date July 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01782235
Other Study ID Numbers  ICMJE 5206
2012-002045-37 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jacques-Eric Gottenberg Hôpitaux Universitaires de Strasbourg
PRS Account University Hospital, Strasbourg, France
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP