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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2 October 2017 |
Main ID: |
EUCTR2012-003490-26-DE |
Date of registration:
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05/06/2013 |
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
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Date of first enrolment:
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08/08/2013 |
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: - Ages 1 (12 for patients in Russia) year up to and including 17 years at screening - Diagnosis of systemic juvenile idiopathic arthritis - Inadequate clinical response (in the opinion of the treating physician) to non-steroidal anti-inflammatory drugs (NSAIDs) and corticosteroids - Concurrent treatment with disease-modifying anti-rheumatic drugs (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 -20 weeks prior to baseline depending on biologic agent - Female patients of childbearing potential and male patients with a female partner of childbearing potential must agree with the required contraceptive methods as defined per protocol. 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 (Juvenile Arthritis Disease Activity Score (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 - Prior stem cell transplant at any time
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: 18.0
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 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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Timepoint(s) of evaluation of this end point: - Pharmacokinetic endpoints will be evaluated at fixed timepoints during the first 14 weeks of the study [Weeks 0-14] - 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 8 weeks after the event)
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Primary end point(s): - Serum TCZ concentration and population PK model-predicted PK exposures area under the concentration-time curve (AUC) , maximum plasma concentration (Cmax ) and Cmin) for the initial QW and Q10D dosing regimens at steady state, and the Q2W dosing regimen at steady state in the <30 kg patients - 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
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Secondary Objective: Not applicable
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Main Objective: Primary Objective - To characterize the pharmacokinetics of subcutaneous tocilizumab (SC TCZ) in patients with sJIA - To evaluate the pharmacodynamics of SC TCZ in patients with sJIA - To evaluate the safety of SC TCZ in patients with sJIA
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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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Secondary ID(s)
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WA28118
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NCT01904292
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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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