Adult's Still DiseasePhase 2NCT01002781
Efficacy and Safety of Tocilizumab in Adult's Still Disease
A Phase 2 study testing Tocilizumab in people with Adult's Still Disease, run by Tel-Aviv Sourasky Medical Center at 4 sites in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Adult's Still Disease
- What is being tested?
- Tocilizumab
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 4 sitesIsrael
- Study dates
- Nov 2009to Jul 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Israel4 sites
Bnei Tsion Medical Center
Haifa
Itzhak Rosner, M.D
Rambam Medical Center
Haifa
Alexandra Balbir-Gurman, M.D, 972502061162, a_balbir@rambam.health.gov.il
Tel Aviv Medical Center
Tel Aviv, 64239
Ori Elkayam, M.D, 97236973668, orie@tasmc.health.gov.il
Ayelet Brill, 972524266893, ayeletb@tasmc.health.gov.il
Assaf Harofe Medical Center
Tsrifin
Moshe Tishler, M.D, 972522502909, MosheT@asaf.health.gov.il
About this study
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.
Read the 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
- Conditions
- Adult's Still Disease
- Being tested
- Tocilizumab
- Keywords
- Tocilizumab Still
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Tocilizumab, IV, 8 mg/kg, every 2 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
symptom-free or steroid-free remission at 52 weeks
Measured: 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
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adult's Still DiseaseStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Rambam Health Care Campus, Assaf-Harofeh Medical Center, Bnai Zion Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01002781
- Sponsor's protocol ID
- 0452-09
- Status last verified
- Sep 2009
- First submitted
- 26 Oct 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18358927De 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.
PubMed 19088261Iwamoto 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.
PubMed 12483747
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tocilizumab (a Monoclonal Antibody to Receptor of IL-6) in the Treatment of Adult's Still Disease
- ClinicalTrials.gov ID
- NCT01002781
- Acronym / sponsor ID
- 0452-09
- Conditions
- Adult's Still Disease
- Keywords
- Tocilizumab Still
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Rambam Health Care Campus, Assaf-Harofeh Medical Center, Bnai Zion Medical Center
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TocilizumabTocilizumab, IV, 8 mg/kg, every 2 weeks | Drug | – |
Primary outcome
symptom-free or steroid-free remission at 52 weeks
Time frame: 52 WEEKS
1 secondary outcome
fever, ACR20, inflammatory markers (e.g. CRP, ferritin), need for rescue medication (e.g. methotrexate, anti-TNF alpha) , adverse events
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Background: PubMed 18358927Yokota 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.
- Background: PubMed 19088261De 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.
- Background: PubMed 12483747Iwamoto 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.
Related trials for Adult's Still Disease
RecruitingObservational study
Natural History, Genetics, and Pathophysiology of Systemic Juvenile Idiopathic Arthritis, Adult-Onset Still's Disease, and Related Conditions
Still's Disease, Adult-Onset, Systemic Inflammation
Active, not recruitingObservational study
A Study of Firsekibart Versus Anakinra in Adult-Onset Still's Disease
Still's Disease, Adult-Onset
Active, not recruiting
Therapeutic Value of Sirolimus in Refractory Adult-Onset Still's Disease
Adult-Onset Still's Disease
RecruitingObservational study
A Study on the Use of Canakinumab Among Familial Mediterranean Fever and Still's Disease Patients
Familial Mediterranean Fever, Still Disease
RecruitingObservational study
Rheumatology Patient Registry and Biorepository
Rheumatic Diseases, Adult Onset Still Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tocilizumab in people with Adult's Still Disease, run by Tel-Aviv Sourasky Medical Center at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ori Elkayam, M.D (97236973668, orie@tasmc.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
symptom-free or steroid-free remission at 52 weeks (time frame: 52 WEEKS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01002781, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2009; AzTrials last refreshed its copy on 8 Nov 2026.