Main
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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:
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EUCTR |
Last refreshed on:
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7 February 2022 |
Main ID: |
EUCTR2013-005212-98-DE |
Date of registration:
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19/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Long Term Study to Evaluate the Safety and Benefit of Subcutaneous Tocilizumab in Patients With Polyarticular-Course and Systemic Juvenile Idiopathic Arthritis
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Scientific title:
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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:
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30/06/2014 |
Target sample size:
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104 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-005212-98 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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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
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Phase:
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Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Brazil
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Canada
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France
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Germany
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Italy
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Mexico
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Russian Federation
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd. |
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Name:
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Trial Information Support Line-TISL
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Address:
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Grenzacherstrasse 124
4070
Basel
Switzerland |
Telephone:
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Email:
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global.rochegenentechtrials@roche.com |
Affiliation:
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F. Hoffmann-La Roche Ltd. |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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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
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Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
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Intervention(s)
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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-
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Primary Outcome(s)
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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
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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
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Secondary Objective: Not applicable
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Timepoint(s) of evaluation of this end point: 1-4. Up to 5 years 5-7. Up to 3 years
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Secondary Outcome(s)
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Secondary end point(s): Not applicable
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Timepoint(s) of evaluation of this end point: Not applicable
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd.
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Ethics review
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Status: Approved
Approval date: 30/06/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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