A study of Baricitinib in children with Juvenile Idiopathic Arthritis (JIA)

Phase 1

• Conditions: Juvenile Idiopathic Arthritis; MedDRA version: 23.1Level: PTClassification code 10059176Term: Juvenile idiopathic arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-004471-31-GB
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-13
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

- Have either completed participation in or terminated early from Study JAHV or Study JAHU and have not completed Post Treatment Follow up in those studies.
- Both the child or adolescent and a parent or legal guardian are able to understand and fully participate in the activities of the clinical study and sign their assent (if applicable) and consent, respectively, according to local guidelines.
- Male or nonpregnant, nonbreastfeeding female patients. Patients of childbearing potential who are abstinent or in a same-sex relationship must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with the opposite sex. Otherwise, patients and their partners of childbearing potential must agree to use 2 effective methods of contraception.
Are the trial subjects under 18? yes
Number of subjects for this age range: 410
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

- Had investigational product permanently discontinued in the originating study
- Had temporary investigational product interruption at the final study visit of the originating study and, in the opinion of the investigator, this poses an unacceptable risk for the patient’s participation in the current study
Medical Conditions
- Have a known hypersensitivity to baricitinib or any component of this investigational product
- Active anterior uveitis or receiving concurrent treatment for anterior uveitis
- Have significant uncontrolled cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that developed during the originator study that, in the opinion of the investigator, could constitute an unacceptable risk to the patient if investigational product continues
- Have any other condition that, in the opinion of the investigator, renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol
- Intends to donate blood during the course of the study
- Intend to receive a live vaccine (except booster immunization with attenuated vaccine for measles, mumps, and rubella [MMR] or varicella-zoster virus [VZV]) during the course of the study, or up to 28 days after the last dose of study drug. Booster vaccination for MMR or VZV may be considered if it is essential based on the local guideline and/or in the opinion of the investigator.
- Currently enrolled in any other clinical study (except the originating study at screening for the current study) involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified