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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
| Assaf-Harofeh Medical Center | OTHER_GOV |
| Bnai Zion Medical Center | OTHER_GOV |
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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.
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab | Drug | Tocilizumab, IV, 8 mg/kg, every 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| symptom-free or steroid-free remission at 52 weeks | 52 WEEKS |
| Measure | Description | Time Frame |
|---|---|---|
| fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events | 52 weeks |
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Inclusion Criteria:
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
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ori Elkayam, M.D | Contact | 97236973668 | orie@tasmc.health.gov.il | |
| Ayelet Brill, M.D | Contact | 972524266894 | ayeletb@tasmc.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bnei Tsion Medical Center | Haifa | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18358927 | Background | 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. | |
| 19088261 |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Rambam Medical Center | Haifa | Israel |
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| Tel Aviv Medical Center | Tel Aviv | 64239 | Israel |
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| Assaf Harofe Medical Center | Ẕerifin | Israel |
|
| Background |
| 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. |
| 12483747 | Background | 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. |