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Efficacy and Safety of Tocilizumab in Adult's Still Disease

Primary Purpose

Adult's Still Disease

Status
Unknown status
Phase
Phase 2
Locations
Israel
Study Type
Interventional
Intervention
Tocilizumab
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult's Still Disease focused on measuring Tocilizumab Still

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bnei Tsion Medical Center
  • Rambam Medical Center
  • Tel Aviv Medical Center
  • Assaf Harofe Medical Center

Outcomes

Primary Outcome Measures

symptom-free or steroid-free remission at 52 weeks

Secondary Outcome Measures

fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events

Full Information

First Posted
October 26, 2009
Last Updated
October 26, 2009
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rambam Health Care Campus, Assaf-Harofeh Medical Center, Bnai Zion Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01002781
Brief Title
Efficacy and Safety of Tocilizumab in Adult's Still Disease
Official Title
Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Rambam Health Care Campus, Assaf-Harofeh Medical Center, Bnai Zion Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult's Still Disease
Keywords
Tocilizumab Still

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Intervention Description
Tocilizumab, IV, 8 mg/kg, every 2 weeks
Primary Outcome Measure Information:
Title
symptom-free or steroid-free remission at 52 weeks
Time Frame
52 WEEKS
Secondary Outcome Measure Information:
Title
fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events
Time Frame
52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ori Elkayam, M.D
Phone
97236973668
Email
orie@tasmc.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Ayelet Brill, M.D
Phone
972524266894
Email
ayeletb@tasmc.health.gov.il
Facility Information:
Facility Name
Bnei Tsion Medical Center
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Itzhak Rosner, M.D
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Balbir-Gurman, M.D
Phone
972502061162
Email
a_balbir@rambam.health.gov.il
Facility Name
Tel Aviv Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ori Elkayam, M.D
Phone
97236973668
Email
orie@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ayelet Brill
Phone
972524266893
Email
ayeletb@tasmc.health.gov.il
First Name & Middle Initial & Last Name & Degree
Dan Caspi, M.D
First Name & Middle Initial & Last Name & Degree
Daphna Paran, M.D
First Name & Middle Initial & Last Name & Degree
Hagit Savargil-Maman, M.D
Facility Name
Assaf Harofe Medical Center
City
Tsrifin
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moshe Tishler, M.D
Phone
972522502909
Email
MosheT@asaf.health.gov.il

12. IPD Sharing Statement

Citations:
PubMed Identifier
18358927
Citation
Yokota S, Imagawa T, Mori M, Miyamae T, Aihara Y, Takei S, Iwata N, Umebayashi H, Murata T, Miyoshi M, Tomiita M, Nishimoto N, Kishimoto T. Efficacy and safety of tocilizumab in patients with systemic-onset juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled, withdrawal phase III trial. Lancet. 2008 Mar 22;371(9617):998-1006. doi: 10.1016/S0140-6736(08)60454-7.
Results Reference
background
PubMed Identifier
19088261
Citation
De Bandt M, Saint-Marcoux B. Tocilizumab for multirefractory adult-onset Still's disease. Ann Rheum Dis. 2009 Jan;68(1):153-4. doi: 10.1136/ard.2008.088179. No abstract available.
Results Reference
background
PubMed Identifier
12483747
Citation
Iwamoto M, Nara H, Hirata D, Minota S, Nishimoto N, Yoshizaki K. Humanized monoclonal anti-interleukin-6 receptor antibody for treatment of intractable adult-onset Still's disease. Arthritis Rheum. 2002 Dec;46(12):3388-9. doi: 10.1002/art.10620. No abstract available.
Results Reference
background

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Efficacy and Safety of Tocilizumab in Adult's Still Disease

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