Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.

• Register: EUCTR
• Last refreshed on: 8 August 2022
• Main ID: EUCTR2013-005212-98-ES
• Date of registration: 09/06/2014
• Prospective Registration: Yes
• Primary sponsor: Roche Farma S.A. en nombre de F. Hoffmann-La Roche Ltd
• Public title: Long term study to evaluate the safety and benefit of subcutaneous RoActemra/Actemra in the treatment of Juvenile Idiopathic Arthritis patients.
• Scientific title: LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF SUBCUTANEOUS TOCILIZUMAB IN PATIENTS WITH POLYARTICULAR-COURSE AND SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS
• Date of first enrolment: 16/06/2014
• Target sample size: 96
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005212-98
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; 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: 2
• Phase: Human pharmacology (Phase I): yes Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Peru, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Trial Inform Support -Marta Maislan
• Affiliation: F. Hoffmann-La Roche Ltd.

• Name: Trial Inform Support -Marta Maislan
• Affiliation: F. Hoffmann-La Roche Ltd.

Key inclusion & exclusion criteria

Inclusion criteria:
- Completion of either of the JIGSAW studies, study WA28117 (for patients with pcJIA) or study WA28118 (for patients with sJIA)

- Adequate disease control with the use of SC RoActemra/Actemra, as assessed by the investigator

- Written informed consent for study participation obtained from the patient (for patients >/= 18 years old) or the patients parents or guardian, with assent as appropriate by the patient, depending on the level of the patients understanding

- For patients of reproductive potential: use of effective contraception as defined by the study protocol
Are the trial subjects under 18? yes
Number of subjects for this age range: 96
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion criteria:
- Therapy with biologic agents (except RoActemra/Actemra) in the period between completion of the JIGSAW study and screening for the current study

- Concurrent treatment with DMARDs (including MTX), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator

- Use of live or attenuated vaccines and immunosuppressants, such as cyclosporine and cyclophosphamide, is prohibited

- Pregnancy or breast-feeding

- Any significant concurrent medical or surgical conditions or findings that would jeopardize the patients safety or ability to complete the study, including but not limited to disease of the nervous, renal, hepatic, cardiac, pulmonary, gastric, or endocrine system or any infection

- History of alcohol, drug, or chemical abuse within 6 months prior to screening

- History of atypical tuberculosis (TB) or active TB requiring treatment within 2 years prior to screening




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

Health Condition(s) or Problem(s) studied

Polyarticular-course juvenile idiopathic arthritis (pcJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 17.0 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: RoActemra
Product Name: tocilizumab SC
Product Code: Ro 487-7533/F10-04
Pharmaceutical Form: Solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB SC
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: Up to 3 years

Secondary Objective: Exploratory objectives:
To assess long-term pharmacodynamics of SC TCZ in patients with pcJIA and sJIA
To assess long-term pharmacokinetics of SC TCZ in patients with pcJIA and sJIA

Main Objective: To evaluate the long-term safety of SC administration of TCZ in patients with pcJIA and sJIA
To describe the long-term efficacy of SC TCZ in patients with pcJIA and sJIA

Primary end point(s): Incidence of adverse events
Incidence of serious adverse events
Incidence of adverse events of special interest
Incidence of clinical laboratory abnormalities
Change in Juvenile Arthritis Disease Activity Score (JADAS-71)
Change in Childhood Health Assessment Questionnaire (CHAQ) score
Inactive disease/clinical remission

Secondary Outcome(s)

Secondary end point(s): The exploratory PK outcome measures will be trough TCZ plasma concentrations measured at specified time-points, and those for PD include Soluble IL-6R (sIL-6R) levels, CRP, ESR , and incidence of anti-TCZ antibodies.

Timepoint(s) of evaluation of this end point: Up to 3 years

Secondary ID(s)

2013-005212-98-DE

WA29231

Source(s) of Monetary Support

F. Hoffmann-La Roche Ltd.

Ethics review

Status: Approved
Approval date: 05/06/2014
Contact:

Results

• Results available: Yes
• Date Posted: 11/06/2022
• Date Completed: 24/11/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2013-005212-98/results