- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01002781
Efficacy and Safety of Tocilizumab in Adult's Still Disease
Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
Study Overview
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
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Ayelet Brill, M.D
- Phone Number: 972524266894
- Email: ayeletb@tasmc.health.gov.il
Study Locations
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Haifa, Israel
- Rambam Medical Center
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Contact:
- Alexandra Balbir-Gurman, M.D
- Phone Number: 972502061162
- Email: a_balbir@rambam.health.gov.il
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Haifa, Israel
- Bnei Tsion Medical Center
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Contact:
- Itzhak Rosner, M.D
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Tel Aviv, Israel, 64239
- Tel Aviv Medical Center
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Contact:
- Ayelet Brill
- Phone Number: 972524266893
- Email: ayeletb@tasmc.health.gov.il
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Sub-Investigator:
- Dan Caspi, M.D
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Sub-Investigator:
- Daphna Paran, M.D
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Principal Investigator:
- Hagit Savargil-Maman, M.D
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Tsrifin, Israel
- Assaf Harofe Medical Center
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Contact:
- Moshe Tishler, M.D
- Phone Number: 972522502909
- Email: MosheT@asaf.health.gov.il
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
symptom-free or steroid-free remission at 52 weeks
Time Frame: 52 WEEKS
|
52 WEEKS
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events
Time Frame: 52 weeks
|
52 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0452-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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