Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)

• Register: EUCTR
• Last refreshed on: 7 January 2013
• Main ID: EUCTR2009-013091-40-DE
• Date of registration: 11/12/2009
• Prospective Registration: Yes
• Primary sponsor: Abbott GmbH & Co. KG
• Public title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)
• Scientific title: Compassionate Use Study of Adalimumab in Children 2 to < 4 Years Old or Age 4 and Above Weighing Less Than 15 kg with Active Juvenile Idiopathic Arthritis (JIA)
• Date of first enrolment: 17/05/2010
• Target sample size: 30
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-013091-40
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:

Countries of recruitment

Czech Republic, France, Germany, Sweden

Key inclusion & exclusion criteria

Inclusion criteria:
1. A parent or guardian has voluntarily signed and dated an informed consent form,
approved by an Institutional Review Board (IRB)/Independent Ethics Committee
(IEC), after the nature of the study has been explained and the subject's parent or
legal guardian has had the opportunity to ask questions. The informed consent
must be signed before any study-specific procedures are performed or before any
medication is discontinued for the purpose of this study. The parent must also be willing to comply with all requirements of this study protocol.
2. Subject has a disease diagnosis of moderately to severely active polyarticular or
polyarticular course JIA (defined as arthritis affecting = 5 joints at the time of
treatment initiation). This corresponds to the International League of Associations
for Rheumatology (ILAR: Appendix C) categories of polyarticular rheumatoid
factor positive (RF+), polyarticular Rheumatoid factor negative (RF-) disease and extended oligoarthritis disease.
3. Subject must be aged 2 to < 4 years old with moderately to severely active
polyarticular JIA or polyarticular course JIA or age 4 or greater weighing < 15 kg
with moderately to severely active polyarticular JIA or polyarticular course JIA,
per ILAR criteria.
4. Subject is judged to be in generally good health as determined by the Investigator
based upon the results of medical history, laboratory profile, and physical
examination performed at Screening and confirmed at Baseline. This includes, but
is not limited to, a normal cardiopulmonary and normal neurological exam result.
5. Parent or legal guardian must be able and willing to administer subcutaneous (SC)
injections or have a qualified person available to administer SC injections.
6. Parent or legal guardian must be 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.
7. Subject must have negative PPD test (or equivalent) at Screening. If subject has a
positive (greater than or equal to 5mm in duration) PPD test result, a chest X-ray (PA and lateral view) must be performed. Ifsubject has a positive test (or equivalent), has had a post ulcerative reaction to PPD placement, and/or a chest x-ray consistent with TB exposure, subject may not be enrolled into the study.
8. For subjects in the EU, subject must have previously failed, had an insufficient response, or have been intolerant to at least one Disease-Modifying Anti-Rheumatic drug (DMARD).

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:
1. Subject has had prior exposure to Tysabri® (natalizumab) or Raptiva® (efalizumab) or any other biologic therapy, such as Orencia® (abatacept). Any previous use of anti-TNF agents, including Enbrel® (etanercept), Remicade® (infliximab), Cimzia® (certolizumab pegol), Simponi® (golimumab), and adalimumab is also prohibited.
2. Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to Baseline Visit or oral anti-infectives within 14 days prior to the Baseline Visit.
3. Subject has undergone joint surgery within the preceding two months of the Screening Visit (at joints to be assessed within the study).
4. Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
5. Subject has a history of an allergic reaction or significant sensitivity to constituents of the study drug, adalimumab.
6. Subject has been treated with any investigational drug of chemical or biologic nature (e.g., Kineret® (anakinra) and Rituxan (rituximab) within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline visit. Should these biologics become approved, they would continue to be excluded.
7. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, recent cerebrovascular accidents, seizure disorder, and any other condition which, in the opinion of the Investigator, would put the subject at risk by participation in the study.
8. Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia, a clotting disorder), renal, liver disease (e.g., fibrosis, cirrhosis, hepatitis), or active gastroenteric ulcer.
9. Subject is considered by the Investigator, for any reason, to be an unsuitable candidate for the study.
10. Subject has evidence of active TB infection.
11. Subject has history of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident or thrombotic event and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
12. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia).
13. History of demyelinating disease (including myletis) or neurologic symptoms suggestive of CNS demyelinating disease.
14. History of invasive fungal infection (e.g., listeriosis, histoplasmosis), active viral
disorders, human immunodeficiency virus (HIV) infection.
15. Positive Hepatitis B test result.
16. Chronic recurring infections or active TB.
17. Screening laboratory and other analyses show any of the following abnormal results:
? ECG – with clinically significant abnormalities;
? Aspartate transaminases (AST) or alanine transaminase (ALT) > 1.75 × the upper limit of the reference range;
? Total bilirubin = 3 mg/dL;
? Serum creatinine > 1.6 mg/dL (convert to mmol/L).
18. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully
treated non-metastatic cutaneous squamous cell or basal cell carcinoma.
E.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Juvenile Idiopathic Arthritis (JIA)
MedDRA version: 12.0 Level: LLT Classification code 10059176 Term: Juvenile idiopathic arthritis

Intervention(s)

Trade Name: Humira
Product Name: Adalimumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Main Objective: The primary objective of this study is to evaluate the safety of adalimumab in subjects 2 to < 4 years of age and subjects age 4 and above that weigh < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA.

Primary end point(s): The primary study endpoint, measured over the course of the study is the incidence rate of serious adverse events (SAEs) and adverse events (AEs) in polyarticular JIA Subjects 2 to < 4 years old and Subjects 4 years and above weighing less than 15 kg.

Secondary Objective: The secondary objectives of this study are to collect PK data and to evaluate the efficacy of adalimumab in Subjects 2 to < 4 years of age and subjects age 4 and above that weigh < 15 kg with moderately to severely active polyarticular JIA or polyarticular course JIA.

Secondary ID(s)

M10-444

2009-013091-40-FR