DRKS00000071
Active, not recruiting
Phase 3
Phase III, multi-center, randomized, double-blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab
Asklepios Klinik Sankt Augustin0 sites32 target enrollmentFebruary 6, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- juvenile ankylosing spondylitis
- Sponsor
- Asklepios Klinik Sankt Augustin
- Enrollment
- 32
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •IN1Parents / legal guardian are willing to participate in the study and signed voluntarily the Informed Consent form.
- •\-IN2Parents / legal guardian are willing to actively supervise storage and administration of study drug and to ensure that the time of each dose is accurately recorded in the subject's diary.
- •\-IN3Patient and parents / legal guardian agree to comply with study requirements and are able to be at the clinic for all required study visits.
- •\-IN4Patient is at least 12 years old and has not reached his 18th birthday.
- •\-IN5The weight of the patient is \> 30 kg.
- •\-IN6IN FEMALE PATIENT IN WHOM MENARCHE HAS OCCURRED
- •\>Negative serum pregnancy test prior to administration of study medication.
- •\>Willingness to use an adequate method of contraception
- •Adequate contraception can include abstinence if the investigator deems appropriate.
- •\-IN7Patient has a diagnosis of juvenile ankylosing spondylitis, i.e.
Exclusion Criteria
- •\-EX1Patient has been diagnosed to have systemic onset of JRA / JIA or has active systemic features including fever or rash.
- •\-EX2Patient has active uveitis within a period of 4 weeks prior to the first administration of study medication.
- •\-EX3Pregnant or breast feeding female.
- •\-EX4Female not willing to use appropriate contraception or sexual abstinence.
- •\-EX5Chronic or active infectious disease, especially patient is positive for the hepatitis B surface antigen.
- •\-EX6Preceding severe infectious disease during a period of 3 months prior to the first administration of study medication.
- •\-EX7Preceding diagnosis of tuberculosis or any opportunistic infection including herpes zoster at any time.
- •\-EX8Any preceding diagnosis of malignancy.
- •\-EX9Patient has a history of any chronic disease other than JAS, JRA / JIA, especially chronic renal disease, liver disease, hematological, gastrointestinal, pulmonary, cardiological or neurological disease, which in the opinion of the investigator may influence the efficacy or safety of the study medication or which in the opinion of the investigator leads to an unacceptable risk for the patient if he participates in the study.
- •\-EX10Patient had a significant illness during a period of 4 weeks prior to the first administration of study medication other than JAS\-related.
Outcomes
Primary Outcomes
Not specified
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