Randomised controlled trial of the clinical effectiveness, SafetY and Cost effectiveness of Adalimumab in combination with MethOtRExate for the treatment of juvenile idiopathic arthritis associated uveitis

niversity Hospitals Bristol NHS Foundation Trust (UK)0 sites90 target enrollmentSeptember 2, 2011

ConditionsOphthalmology Eye Diseases Iridocyclitis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Ophthalmology
Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)
Enrollment: 90
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24405833 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28445659 2018 cost-effectiveness results in: https://www.ncbi.nlm.nih.gov/pubmed/30336181 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31033434 (added 30/04/2019)

Registry

who.int

Start Date

September 2, 2011

End Date

October 1, 2015

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity Hospitals Bristol NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

•Inclusion criteria as of 20/12/2016:
•1\. Children and young people aged \= 2 and \<18 years fulfilling ILAR diagnostic criteria for JIA (all subgroups that have uveitis)
•2\. At the time of trial screening the participant must have active anterior uveitis, defined as a sustained grade of cellular infiltrate in anterior chamber of SUN criteria grade \>1\+ or more during the preceding 12 weeks therapy despite MTX and corticosteroid (both systemic and topical) therapy”. The latest date of SUN grade score must be the date of the screening visit
•3\. They must have failed MTX (minimum dose of 10\-20mg/m2, with a maximum dose of 25mg/participant). The participant must have been on MTX for at least 12 weeks\* and have been on a stable dose for 4 weeks prior to screening visit.
•4\. No Disease modifying immunosuppressive drugs, other than MTX, in the 4 weeks prior to screening
•5\. Written informed consent of participant or parent/legal guardian, and assent where appropriate
•6\. Participant and parent/legal guardian willing and able to comply with protocol requirements
•7\. For participants of reproductive potential (males and females), use of a reliable means of contraception throughout their trial participation. Post pubertal females must have a negative serum pregnancy test within 10 days before the first dose of trial drug.
•8\. Able to be randomised and commence trial treatment within 2 weeks of the screening visit
•\* Omission of a maximum of 2 weeks methotrexate treatment within the 12 weeks is acceptable and will not render the patient ineligible unless they have been missed in the 4 weeks prior to the screening visit.

Exclusion Criteria

•Exclusion criteria as of 20/12/2016:
•1\. Uveitis without a diagnosis of JIA
•2\. Currently on adalimumab or has previously received adalimumab.
•3\. Have been on other biologic agent within previous 5 half\-lives of agent (For other biologic agents and their was out periods
•4\. More than 6 topical steroid eye drops per eye, per day prior to screening (this dose must have been stable for at least 4 weeks prior to screening visit)
•5\. For patients on Prednisone or Prednisone equivalent, change of dose within 30 days prior to screening
•6\. For patients on Prednisone or Prednisone equivalent with a dose \>0\.2mg/kg per day
•7\. Intra\-articular joint injections within four weeks prior to screening
•8\. Any ongoing chronic or active infection (including infective uveitis) or any major episode of infection requiring hospitalisation or treatment with intravenous antibiotics within 30 days or oral antibiotics within 14 days prior to the screening evaluation
•9\. History of active tuberculosis of less than 6 months treatment or untreated latent TB