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: 30 April 2019
• Main ID: EUCTR2009-013091-40-FR
• Date of registration: 10/12/2009
• 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: 22/02/2010
• 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:
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Czech Republic, Denmark, France, Germany, Slovakia, 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.
2. Subject has a disease diagnosis of moderate to severe 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+), and polyarticular Rheumatoid factor negative (RF-) 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 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 must have
documented completion of course of anti-TB therapy.

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 any other biologic
therapy, such as Orencia® (abatacept). Any previous use of anti-TNF agents,
including Etanercept (Enbrel®), Infliximab (Remicade®), certolizumab pegol,
golimumab, and adalimumab is also prohibited.
2. Subject has undergone joint surgery within the preceding two months of the
Screening Visit (at joints to be assessed within the study).
3. Subject has a previous diagnosis of a condition that could cause arthritis other than polyarticular JIA.
4. Subject has a history of an allergic reaction or significant sensitivity to constituents
of the study drug, adalimumab.
5. Subject has been treated with any investigational biologic agents (e.g., Kineret®
(anakinra) and Rituxan (rituximab). Should these biologics become approved,
they would continue to be excluded.
6. 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.
7. 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.
8. Subject is known to have any acquired immune deficiency (i.e., HIV infection) or
untreated congenital immunodeficiency. Abbott Study-Designated Physician
approval required for specific congenital immunodeficiency cases.
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. History of CNS demyelinating disease or neurologic symptoms suggestive of CNS
demyelinating disease.
13. History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection,
human immunodeficiency virus (HIV) infection, immunodeficiency syndrome,
chronic recurring infections or active TB.


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

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 22/07/2015
• Date Completed: 21/03/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2009-013091-40/results