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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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17 July 2017 |
Main ID: |
EUCTR2012-003490-26-ES |
Date of registration:
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26/06/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A study of a new sub-cutaneous formulation of Actemra/RoActemra in children with systemic juvenile idiopathic arthritis
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Scientific title:
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A PHASE Ib, OPEN-LABEL, MULTICENTER STUDY TO INVESTIGATE THE PHARMACOKINETICS, PHARMACODYNAMICS, AND SAFETY OF TOCILIZUMAB FOLLOWING SUBCUTANEOUS ADMINISTRATION TO PATIENTS WITH SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS |
Date of first enrolment:
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26/06/2013 |
Target sample size:
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48 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-003490-26 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: no
Randomised:
Open:
Single blind:
Double blind:
Parallel group:
Cross over:
Other:
If controlled, specify comparator, Other Medicinial Product:
Placebo:
Other:
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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: - Children 1-17 years of age - Diagnosis systemic juvenile idiopathic arthritis - Inadequate clinical response (in the opinion of the treating physician) to NSAIDs and corticosteroids - Concurrent treatment with DMARDs (including methotrexate [MTX]), NSAIDs, and oral corticosteroids is permitted at the discretion of the investigator. - Discontinuation of biologic agents (other than tocilizumab if the patient is receiving IV TCZ) for 4 days to 20 weeks prior to baseline depending on biologic agent Are the trial subjects under 18? yes Number of subjects for this age range: 48 F.1.2 Adults (18-64 years) no 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: - Prior discontinuation of IV TCZ because of inadequate clinical response or safety events - Patients with poorly controlled disease (in the opinion of the treating physician) despite current treatment with IV TCZ - sJIA that is well controlled by any treatment agent other than TCZ (JADAS-71?3.8 with no fever) - Patients who are wheelchair-bound or bedridden - Any other auto-immune, rheumatic disease, or overlapping syndrome other than sJIA
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Systemic Juvenile Idiopathic Arthritis (sJIA) MedDRA version: 16.0
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 in pre-filled syringe INN or Proposed INN: tocilizumab CAS Number: 375823-41-9 Current Sponsor code: RO4877533 Other descriptive name: recombinant antihumanized anti-human monoclonal antibody directed against the IL-6R Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 180-
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Primary Outcome(s)
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Secondary Objective: Secondary objectives: - To evaluate the pharmacodynamics of SC TCZ in patients with sJIA - To evaluate the safety of SC TCZ in patients with sJIA
Exploratory Objective To describe the efficacy of SC TCZ in patients with sJIA
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Primary end point(s): Serum TCZ concentration and population PK model-predicted PK exposures (AUC, Cmax and Cmin) for the QW and Q10D dosing regimens at steady state
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Main Objective: Primary Objective - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA
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Timepoint(s) of evaluation of this end point: Fixed timepoints during the first 14 weeks of the study
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Secondary Outcome(s)
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Secondary end point(s): Secondary endpoints: - Serum IL-6 and soluble IL-6R (sIL-6R) levels, C-reactive protein (CRP), and erythrocyte sedimentation rate (ESR) - The incidence and severity of adverse events (including local injection-site reactions) and serious adverse events - The incidence and severity of adverse events of special interest - The incidence and severity of clinical laboratory abnormalities - The incidence of anti-TCZ antibodies
Exploratory endpoints: - Juvenile Arthritis Disease Activity Score (JADAS)-71 - Inactive disease and clinical remission - Childhood Health Assessment Questionnaire (CHAQ)
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Timepoint(s) of evaluation of this end point: Secondary endpoints: - Pharmacodynamic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - Adverse events, adverse events of special interest and clinical laboratory abnormalities will be recorded for the entire duration of the study [Weeks 0-52] - The presence of anti-TCZ antibodies will be evaluated at baseline and at regular intervals with event-driven testing in cases of anaphylaxis, serious hypersensitivity events, or any hypersensitivity event (including non-serious events) leading to treatment withdrawal (at the time of the event and at least 6 weeks after the event)
Exploratory endpoints: - All endpoints will be measured for the duration of the study [Weeks 0-52]
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Secondary ID(s)
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WA28118
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2012-003490-26-DE
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Source(s) of Monetary Support
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F. Hoffmann-La Roche Ltd
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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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