Phase III, multi-center, randomized, double blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab - Humira Study

• Conditions: Juvenile ankylosing spondylitis; MedDRA version: 10Level: LLTClassification code 10002556Term: <Manually entered code. Term in E.1.1>

• Registration Number: EUCTR2007-003358-27-DE
• Lead Sponsor: Center of Pediatrics and Neonatology, Asklepios Clinic Sankt Augustin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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®.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified