Phase III, multi-center, randomized, double-blind, placebo-controlled study for treatment of juvenile ankylosing spondylitis with Adalimumab
- Conditions
- juvenile ankylosing spondylitisM08.1Juvenile ankylosing spondylitis
- Registration Number
- DRKS00000071
- Lead Sponsor
- Asklepios Klinik Sankt Augustin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting stopped after recruiting started
- Sex
- All
- Target Recruitment
- 32
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.
Abilateral active sacroiliitis confirmed by magnetic resonance imaging is present
OR
Bunilateral active sacroiliitis confirmed by magnetic resonance imaging is present, and patient has active peripheral joint disease restricted to the lower extremities (hip, knee, ankle)
AND at least 1 clinical criterion is fulfilled:
1.limitation of lumbar spine motion in all three planes
2.pain or history of pain at the dorsolumbar junction of the lumbar spine
3.limitation of chest expansion to 2.5 cm or less at the level of the fourth intercostal space.
-IN8Patient 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.
-IN9The disease has been refractory to at least two different non-steroidal antiphlogistic drugs given at appropriate dosage and for appropriate period of time.
-IN10Patient has not been treated with either etanercept or infliximab or adalimumab or anakinra at any time for any period.
-IN11Patient is able and willing to self-administer sc injections or has a suitable person at his disposal to administer sc injections.
-IN12Patient must be evaluated for active or latent TB infection according to the instructions of the protocol. If applicable: Guidelines regarding the treatment of latent TB must be followed prior to the administration of study medication.
-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.
-EX11Patient is abusing alcohol or drugs.
-EX12Patient has been treated with antimalarials, gold salts, sulphasalazine, azathioprine, penicillamine, leflunomide, cyclosporine A, intravenous immunoglobulin, or methotrexate within 4 weeks prior to the first administration of study medication, or plans to begin the intake of these drugs.
-EX13Patient has been exposed to etanercept or infliximab or adalimumab or anakinra before receiving the first dose of study medication.
-EX14Patient has begun the intake or changed the dose regimen of oral corticosteroids within 4 weeks before Screening, doses of up to 0.2 mg/kg or 10 mg prednisone or equivalent per day, whichever is less, are allowed.
-EX15Patient plans to change dosing of oral corticosteroids within the study period.
-EX16Patient has received i.v., i.m., i.a. or soft tissue injections of corticosteroids within 4 weeks before first administration of study medication.
-EX17Patient has previously been admitted to this study.
-EX18Patient has been treated with any other investigational agent within 30 days or 5 half-lifes of the agent, whichever is longer, prior to the screening evaluation.
-EX19Patient has been treated with any investigational biologic agent within 6 months prior to the screening evaluation.
-EX20Demonstration of clinically significant deviations in any of the following laboratory parameters:
>platelet count < 100.000/mm3
>total white cell count < 4000 cells/mm3
>neutrophils < 1000 cells/mm3
>hematocrit < or = 24%
>AST or ALT or serum bilirubin > 2x the upper limit of normal
>glomerular filtration rate GFR < 90 mL/min / 1.73 m2 BSA
[GFR (mL/min / 1.73 m2 BSA) = 0.55 x height (cm) / plasma creatinine (mg/dL)]
-EX21Patient has a history of an expanding CNS neoplasm, active CNS infection, demyelinating disease, degenerative neurological disease or any progressive CNS disease.
-EX22Patient has a poorly controlled diabetes.
-EX23Any concurrent medical condition which would, in the investigator's opinion, compromise the patient's ability to tolerate the study drug or would make the patient unable to comply with the
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -to demonstrate the superiority of adalimumab with respect to the ASAS Working Group response criterion ASAS40 as compared to placebo<br>-to contrast the safety profile of adalimumab with placebo in subjects with juvenile ankylosing spondylitis.
- Secondary Outcome Measures
Name Time Method - to show improvement of each of the 4 categories contributing to the ASAS40 criterion (spinal inflammation, back pain, patient's global assessment, physical function)<br>- to show superiority of adalimumab with respect to the ACR Ped 30 response criterion as compared to placebo<br>- to show improvement of each of the 6 categories contributing to the ACR Ped Score (physician's global assessment, parents' global assessment of subject's overall well-being, number of active joints, number of joints with limitation of motion, physical function, CRP).