Efficacy and Safety of Tocilizumab in Adult's Still Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Rambam Health Care Campus
Assaf-Harofeh Medical Center
Bnai Zion Medical Center
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01002781
First received: October 26, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

Patients with adult's Still disease suffer from acute inflammatory symptoms such as fever, arthritis, rash, and acute phase response often requiring high dose corticosteroids. In view of several case reports which have shown dramatic improvement in patients treated with Tocilizumab and a phase 2 study of this drug in children with Still's disease, the objective of the current study is to assess the efficacy and safety of Tocilizumab in patients with adult's Still disease.


Condition Intervention Phase
Adult's Still Disease
Drug: Tocilizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • symptom-free or steroid-free remission at 52 weeks [ Time Frame: 52 WEEKS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: November 2009
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tocilizumab
    Tocilizumab, IV, 8 mg/kg, every 2 weeks
Detailed Description:

This is a multicenter, open, study designed to investigate the effect of Tocilizumab, a monoclonal antibody to IL-6 receptor, on the management of active adult-onset Still's disease.

Standard medication of corticosteroid will be given to all patients at the discretion of the treating physician.

Visits will include : screening visit, week o, week 2 , and every 4 weeks after during 52 weeks After complying with the inclusion and exclusion criteria, patients will start treatment with Tocilizumab at a dosage of 8 mg/kg, every 2 weeks Patients will be assessed every visit for the presence of fever, tender and swollen joint, rash, dosage of corticosteroids and other DMARD's, CRP and ESR

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have been diagnosed with adult-onset Still's disease according to the criteria of Yamaguchi (at least 5 criteria in total, including at least 2 major criteria), although these criteria do not have to be present at the time of inclusion in the study.

Major criteria are:Fever ≥39°C for at least 1 week,Arthralgia lasting at least 2 weeks,Maculo-papular, non-pruritic skin rash,Leucocytosis .≥10,000/mm³) including ≥80% neutrophils;Minor criteria are:Pharyngitis or sore throat,Lymphadenopathy or splenomegaly,Liver enzyme (transaminase) abnormalities,Negative for rheumatoid factor or antinuclear antibodies

  • Patients aged >18
  • Capable of signing informed consent

Exclusion Criteria:

  • active infections (especially sepsis and Epstein-Barr virus),
  • malignant disease (especially lymphomas),
  • other autoimmune or inflammatory disease (especially polyarteritis nodosa)
  • patients will be required to restrict other treatments for Still's disease to low-dose corticosteroids +/- non steroidal anti inflammatory drugs for at least the first 4 weeks of the study.
  • pregnant or breast-feeding women
  • women of childbearing potential unwilling to use adequate contraception and not become pregnant during the course of the study
  • previous treatment with other biologic antirheumatic agents will require a washout period before inclusion
  • history of listeriosis or latent or active tuberculosis
  • persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections unacceptable per investigator judgment.
  • received administration of any live (attenuated) vaccine within 3 months prior to the inclusion visit
  • known history of Human Immunodeficiency Virus antibody; and/or positive Hepatitis B surface antigen , and/or positive Hepatitis C antibody at the screening visit.
  • history of recurrent herpes zoster.
  • history of prior articular or prosthetic joint infection
  • history of a hypersensitivity reaction, other than localised injection site reaction , to any biological molecule
  • uncontrolled diabetes
  • patients under dialysis
  • presence of any of the following laboratory abnormalities at the screening visit: haemoglobin <8.5g/l, WBC <3000/μL, platelet count <150,000/μL, neutrophils <1500/μL
  • AST or ALT >2 Upper limit and bilirubin >2 Upper limit
  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 ClinicalTrials.gov identifier: NCT01002781

Contacts
Contact: Ori Elkayam, M.D 97236973668 orie@tasmc.health.gov.il
Contact: Ayelet Brill, M.D 972524266894 ayeletb@tasmc.health.gov.il

Locations
Israel
Rambam Medical Center Not yet recruiting
Haifa, Israel
Contact: Alexandra Balbir-Gurman, M.D    972502061162    a_balbir@rambam.health.gov.il   
Bnei Tsion Medical Center Not yet recruiting
Haifa, Israel
Contact: Itzhak Rosner, M.D         
Tel Aviv Medical Center Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Ori Elkayam, M.D    97236973668    orie@tasmc.health.gov.il   
Contact: Ayelet Brill    972524266893    ayeletb@tasmc.health.gov.il   
Sub-Investigator: Dan Caspi, M.D         
Sub-Investigator: Daphna Paran, M.D         
Principal Investigator: Hagit Savargil-Maman, M.D         
Assaf Harofe Medical Center Not yet recruiting
Tsrifin, Israel
Contact: Moshe Tishler, M.D    972522502909    MosheT@asaf.health.gov.il   
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Rambam Health Care Campus
Assaf-Harofeh Medical Center
Bnai Zion Medical Center
  More Information

Publications:
Responsible Party: Ori Elkayam, Israeli Society of Rheumatology
ClinicalTrials.gov Identifier: NCT01002781     History of Changes
Other Study ID Numbers: 0452-09
Study First Received: October 26, 2009
Last Updated: October 26, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Tel-Aviv Sourasky Medical Center:
Tocilizumab Still

Additional relevant MeSH terms:
Still's Disease, Adult-Onset
Arthritis, Juvenile Rheumatoid
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014