World Health Organization site
Skip Navigation Links

Main
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: 19 March 2012
Main ID:  EUCTR2007-003358-27-DE
Date of registration: 21/11/2007
Prospective Registration: Yes
Primary sponsor: Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin
Public title: Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study
Scientific title: Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study
Date of first enrolment: 02/05/2008
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-003358-27
Study type:  Interventional clinical trial of medicinal product
Study design:  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  
Phase: 
Countries of recruitment
Germany
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
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
OR
B unilateral active sacroiliitis confirmed by magnetic resonance imaging is present, and patient has active peripheral joint disease restricted to the lower extremities
AND
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
Health Condition(s) or Problem(s) studied
Juvenile ankylosing spondylitis
MedDRA version: 10 Level: LLT Classification code 10002556 Term:
Intervention(s)

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

Primary Outcome(s)
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.
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.
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).
Secondary Outcome(s)
Secondary ID(s)
HUM06-037
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history