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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: 7 February 2022
Main ID:  EUCTR2013-005212-98-DE
Date of registration: 19/05/2014
Prospective Registration: Yes
Primary sponsor: F. Hoffmann-La Roche Ltd
Public title: Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
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: 30/06/2014
Target sample size: 104
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  
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
Russian Federation Spain United Kingdom United States
Contacts
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
Affiliation:  F. Hoffmann-La Roche Ltd.
Name: Trial Information Support Line-TISL   
Address:  Grenzacherstrasse 124 4070 Basel Switzerland
Telephone:
Email: global.rochegenentechtrials@roche.com
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 TCZ , as assessed by the investigator

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

- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 6 months after the last dose of TCZ

- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm during the treatment period and for at least 6 months after the last dose of TCZ
Are the trial subjects under 18? yes
Number of subjects for this age range: 104
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:
- Prior discontinuation of intravenous (IV) TCZ because of inadequate clinical response or safety events (including hypersensitivity)

- Therapy with biologic agents (except TCZ) in the period between completion of the JIGSAW study and screening for the current study

- Concurrent treatment with disease-modifying anti-rheumatic drugs (including methotrexate ), nonsteroidal anti-inflammatory drugs, 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 (pJIA); Systemic juvenile idiopathic arthritis (sJIA)
MedDRA version: 20.0 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
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 180-

Primary Outcome(s)
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
- Juvenile Arthritis Disease Activity Score (JADAS-71)
- Childhood Health Assessment Questionnaire (CHAQ) score
- Inactive disease/clinical remission
Main Objective: To evaluate the long-term safety of subcutaneous (SC) administration of tocilizumab (TCZ) in patients with pJIA and sJIA for up to 5 years
To describe the long-term efficacy of SC TCZ in patients with pJIA and sJIA for up to 3 years

Secondary Objective: Not applicable

Timepoint(s) of evaluation of this end point: 1-4. Up to 5 years
5-7. Up to 3 years

Secondary Outcome(s)
Secondary end point(s): Not applicable
Timepoint(s) of evaluation of this end point: Not applicable
Secondary ID(s)
WA29231
Source(s) of Monetary Support
F. Hoffmann-La Roche Ltd.
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 30/06/2014
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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