Adult's Still Disease Clinical Trial
Official title:
Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
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.
| Status | Not yet recruiting |
| Enrollment | 10 |
| Est. completion date | July 2011 |
| Est. primary completion date | July 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Israel | Bnei Tsion Medical Center | Haifa | |
| Israel | Rambam Medical Center | Haifa | |
| Israel | Tel Aviv Medical Center | Tel Aviv | |
| Israel | Assaf Harofe Medical Center | Tsrifin |
| Lead Sponsor | Collaborator |
|---|---|
| Tel-Aviv Sourasky Medical Center | Assaf-Harofeh Medical Center, Bnai Zion Medical Center, Rambam Health Care Campus |
Israel,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | symptom-free or steroid-free remission at 52 weeks | 52 WEEKS | No | |
| Secondary | fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events | 52 weeks | Yes |