A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1

• Register: EUCTR
• Last refreshed on: 10 September 2018
• Main ID: EUCTR2014-002872-95-FR
• Date of registration: 18/06/2015
• Prospective Registration: No
• Primary sponsor: Novartis Pharma S.A.S
• Public title: A French extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis who participated in the international study ACZ885G2301E1
• Scientific title: A French open-label extension study of canakinumab in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who participated in the international phase III study CACZ885G2301E1 - CACZ885GFR01
• Date of first enrolment: 15/09/2014
• Target sample size: 15
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-002872-95
• 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: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

France

Contacts

• Name: Information&communication médicales
• Affiliation: Novartis Pharma S.A.S

• Name: Information&communication médicales
• Affiliation: Novartis Pharma S.A.S

Key inclusion & exclusion criteria

Inclusion criteria:
Patients eligible for inclusion in this protocol have to fulfill all of the following criteria:
1. Patients who have completed the international ACZ885G2301E1 study without any significant safety issue and who have not enrolled into the international phase IIIb/IV study ACZ885G2306.
2. Parent’s or legal guardian’s written informed consent and child’s assent, if appropriate, or patient’s written informed consent for patients =18 years of age must be obtained before any study related activity or assessment is performed.

Other criteria may apply
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 3
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1.History of recurring infections, or underlying conditions which may predispose them to infections. Treatment with Ilaris should not be continued in patients with severe infections requiring medical intervention.
2.Hypersensitivity to the active substance or to any of the excipients.
3.Concomitant use of second line agents such as disease-modifying and/or immunosuppressive drugs will not be allowed with the exception of:
•Methotrexate, and folic/folinic acid supplementation (according to standard medical practice)
•Non-steroidal anti-inflammatory drug (NSAID)
•Systemic corticosteroid treatment
4.concomitant use of another biologic agent or any investigational drug.
5.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 hCG laboratory test or an urinary pregnancy test.
6.Female patients who are of child-bearing potential, defined as all females physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. ?
Other criteria may apply


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Systemic Juvenile Idiopathic Arthritis (SJIA) with active systemic manifestations
MedDRA version: 18.0 Level: PT Classification code 10059176 Term: Juvenile idiopathic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

Trade Name: ILARIS
Product Name: canakinumab
Product Code: ACZ885
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: CANAKINUMAB
CAS Number: 914613-48-2
Current Sponsor code: ACZ885
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-

Primary Outcome(s)

Primary end point(s):

Main Objective: The objective of this protocol is to add an extension period to provide continuous therapy and to collect safety data (collection of adverse events serious (SAE) or not (AE)) of French patients who completed the international CACZ885G2301E1 study in France.

Secondary Objective:

Source(s) of Monetary Support

Novartis Pharma S.A.S