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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. |
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Register:
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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2007-003358-27-DE |
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Date of registration:
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21/11/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study
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Scientific title:
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Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study |
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Date of first enrolment:
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02/05/2008 |
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Target sample size:
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003358-27 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Open-label follow-up treatment phase of further 12 weeks
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
IN1: Parents / legal guardian and patient are willing to participate in the study and signed voluntarily the Informed Consent form.
IN4: Patient is at least 12 years old and has not reached his 18th birthday.
IN5: The weight of the patient is > 30 kg.
IN7: Patient has a diagnosis of juvenile ankylosing spondylitis, i.e.
A bilateral active sacroiliitis confirmed by magnetic resonance imaging is present
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B unilateral active sacroiliitis confirmed by magnetic resonance imaging is present, and patient has active peripheral joint disease restricted to the lower extremities
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pain or history of pain at the dorsolumbar junction of the lumbar spine.
IN8: Patient has active disease, i.e.
1. spinal inflammation score of at least 3
AND at least 2 of the following domains:
2. back pain score of at least 3
3. patient global assessment of disease activity of at least 3
4. physical function score of at least 3.
IN9:The disease has been refractory to at least two different non-steroidal antiphlogistic drugs given at appropriate dosage and for appropriate period of time.
Are the trial subjects under 18? yes
Number of subjects for this age range:
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:
EX1: Patient has been diagnosed to have systemic onset of JRA / JIA or has active systemic features including fever or rash.
EX2: Patient has active uveitis within a period of 4 weeks prior to the first administration of study medication.
EX7: Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time.
EX10: Patient had a significant illness during a period of 4 weeks prior to the first administration of study medication other than JAS-related.
EX27: Any contraindication listed in the German 'Fachinformation' of the drug Humira®.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Juvenile ankylosing spondylitis
MedDRA version: 10
Level: LLT
Classification code 10002556
Term:
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Intervention(s)
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Trade Name: Humira®
Pharmaceutical Form: Solution for injection
INN or Proposed INN: adalimumab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use
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Primary Outcome(s)
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Secondary Objective: Secondary objectives of the trial are
• to show improvement of each of the 4 categories contributing to the ASAS40 criterion
1. Spinal inflammation
2. Back pain (total and nocturnal)
3. Patient's global assessment
4. Physical function
• to show superiority of adalimumab with respect to the ACR Ped 30 response criterion as compared to placebo
• to show improvement of each of the 6 categories contributing to the ACR Ped Score
1. Physician's global assessment of subject's disease activity
2. Parent's global assessment of subject's overall well-being
3. Number of active joints
4. Number of joints with limitation of motion
5. Measure of physical function (in this study the Childhood Health Assessment Questionnaire CHAQ will be used)
6. Laboratory measure of inflammation (in this study the CRP will be used).
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Primary end point(s): Response rates according to the ASAS40 criteria at Week 12. A responder is defined as a patient who achieved improvement in at least 3 of 4 domains contributing to the ASAS, with no worsening in the remaining domain:
1. Spinal inflammation
2. Back pain
3. Patient's global assessment
4. Physical function.
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Main Objective: The study is designed to evaluate the safety and efficacy of treatment of juvenile ankylosing spondylitis (JAS) with adalimumab. The primary objectives are
• to demonstrate the superiority of adalimumab with respect to the ASAS Working Group response criterion ASAS40 as compared to placebo
• to contrast the safety profile of adalimumab with placebo in subjects with JAS.
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Secondary ID(s)
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HUM06-037
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Source(s) of Monetary Support
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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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