Efficacy and Safety of Tocilizumab in Adult's Still Disease

NCT01002781 | Unknown Phase 2

• 1 other identifier: 0452-09
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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.

Conditions

Adult's Still Disease

Keywords

Tocilizumab Still

Outcome Measures

Primary Outcomes (1)

• symptom-free or steroid-free remission at 52 weeks

  52 WEEKS

Secondary Outcomes (1)

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

  52 weeks

Interventions

Tocilizumab DRUG

Tocilizumab, IV, 8 mg/kg, every 2 weeks

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead
• Rambam Health Care Campus: collaborator
• Assaf-Harofeh Medical Center: collaborator
• Bnai Zion Medical Center: collaborator

Study Sites (4)

Bnei Tsion Medical Center

Haifa, Israel

Location

Rambam Medical Center

Haifa, Israel

Location

Tel Aviv Medical Center

Tel Aviv, 64239, Israel

Location

Assaf Harofe Medical Center

Ẕerifin, Israel

Location

Related Publications (3)

• 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.

  PMID: 18358927 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.

  PMID: 19088261 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.

  PMID: 12483747 BACKGROUND

MeSH Terms

Interventions

tocilizumab

Central Study Contacts

Ori Elkayam, M.D

CONTACT

97236973668; orie@tasmc.health.gov.il

Ayelet Brill, M.D

CONTACT

972524266894; ayeletb@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: October 26, 2009
• First Posted: October 27, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: October 27, 2009

Record last verified: 2009-09

Locations

IL (4)