|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
EUCTR |
|
Last refreshed on:
|
25 September 2012 |
|
Main ID: |
EUCTR2008-008008-42-DK |
|
Date of registration:
|
30/09/2009 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
|
|
Scientific title:
|
An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations - G2301E1 |
|
Date of first enrolment:
|
10/11/2009 |
|
Target sample size:
|
88 |
|
Recruitment status: |
Not Recruiting |
|
URL:
|
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-008008-42 |
|
Study type:
|
Interventional clinical trial of medicinal product |
|
Study design:
|
Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
Austria
|
Belgium
|
Denmark
|
France
|
Germany
|
Greece
|
Hungary
|
Italy
|
|
Netherlands
|
Spain
|
Sweden
|
United Kingdom
| | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
1. Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s informed consent for = 18 years of age before any study related activity is performed.
2. The following patients are eligible to participate in the open label extension study (CACZ885G2301E1):
• Patients from study CACZ885G2305 or CACZ885G2301 who achieved an adapted ACR pediatric 30 response 15 days after their initial dose of canakinumab but clinically deteriorated as defined by a minimum ACR Pediatric 30 response not being maintained after Day 15 and intervention is deemed necessary by the investigator.
• Patients in study CACZ885G2301 who are not eligible to enter Part II (withdrawal part) because they were not able to meet the corticosteroid entry criteria of 0.5 mg/kg oral prednisone (or equivalent) or were not able to taper their steroids by at least 0.3 mg/kg (please refer to CACZ885G2301 protocol for detailed rules)
• Responder patients in Part I or Part II who were maintaining their minimum ACR pediatric 30 response or had not flared when CACZ885G2301 was stopped.
• CACZ885G2301 patients who were responders in Part I (achieved and maintained a minimum adapted ACR pediatric 30) but experienced a flare in Part II.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive urine pregnancy test at screening visit
2. Female patients having reached sexual maturity, (e.g. Tanner Stage 2 or above), i.e. being physiologically capable of becoming pregnant UNLESS they are:
• Female patients whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and/or
• Using an acceptable method of contraception with a failure rate (Pearl Index (PI)) < 1. Reliable contraception should be maintained throughout the study and for 2 months after study drug discontinuation.
3. History of hypersensitivity to study drug or to biologics.
4. Diagnosis of active macrophage-activation syndrome (MAS) (Ravelli, Magni-Manzoni and Pistorio 2005) during the CACZ885G2305 or CACZ885G2301
5. With active or recurrent bacterial, fungal or viral infection at the time of enrollment, including patients with evidence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B and Hepatitis C infection
6. Risk factors for tuberculosis (TB) such as:
• History of any of the following: residence in a congregate setting (e.g. jail or prison, homeless shelter, or chronic care facility), substance abuse (e.g. injection or noninjection); health-care workers with unprotected exposure to patients who are at high risk of TB or patients with TB disease before the identification and correct airborne precautions of the patient, or
• Close contact (i.e. share the same air space in a household or other enclosed environment for a prolonged period (days or weeks, not minutes or hours)) with a person with active pulmonary TB disease within the last year.
7. With underlying metabolic, renal, hepatic, infectious or gastrointestinal conditions which in the opinion of the investigator immunocompromises the patient and/ or places the patient at unacceptable risk for participation in an immunodulatory therapy. In particular, clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome
8. With significant medical conditions, which in the opinion of the Investigator will exclude the patient from the study (can be discussed on a case by case basis with Novartis)
9. History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
10. Live vaccinations within 3 months prior to the start of the study. Killed or inactivated vaccines may be permitted according to the investigator’s discretion.
11. Donation or loss of blood (amount depending on age and weight, 10-20% or more of volume, see Appendix 3) within 8 weeks prior to first dosing, or longer if required by local regulation.
12. Familial and social conditions rendering regular medical assessment not possible
13. History of drug or alcohol abuse within the 12 months prior to dosing.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
|
|
Health Condition(s) or Problem(s) studied
|
Active systemic manifestations of Systemic Juvenile Idiopathic Arthritis (SJIA)
MedDRA version: 9.1
Level: LLT
Classification code 10059176
Term: Juvenile idiopathic arthritis
|
|
Intervention(s)
|
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Product Name: Canakinumab
Product Code: ACZ885
Pharmaceutical Form: Powder for solution for injection
INN or Proposed INN: Canakinumab
Current Sponsor code: ACZ885
Other descriptive name: Recombinant human monoclonal antibody to human IL-1Beta of the IgG1/K class
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
|
|
Primary Outcome(s)
|
Main Objective: • To assess the long-term safety, tolerability, and immunogenicity of canakinumab
• To assess efficacy at an exploratory level by investigating disease control defined by maintenance of at least an adapted ACR pediatric 30 during the extension part
|
|
Secondary Objective:
|
Primary end point(s): - Long-term safety, tolerability, and immunogenicity of canakinumab
- Disease control by maintenance of at least an adapted ACR pediatric 30 during the extension study
|
|
Secondary ID(s)
|
|
2008-008008-42-FR
|
|
CACZ885G2301E1
|
|
Source(s) of Monetary Support
|
|
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|