E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Juvenile Idiopathic Arthritis (JIA) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059176 |
E.1.2 | Term | Juvenile idiopathic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacokinetic samples will be obtained from a sub-section of subjects after informed consent for this sub-study has been obtained. Refer section 5.3.2.1 of the protocol for further details. |
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E.3 | Principal 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.
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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In section 13 of the protocol the end of the trial is defined as the date of the last subject's last scheduled visit or the actual date of follow-up contact, whichever is longer.
The purpose of the follow-up period is to collect additional safety information. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |