Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab

NCT04200833 | Completed Results FDA Drug

• 1 other identifier: 31-301ex18/19
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To asses the use of golimumab, a fully humanized anti-TNF Alpha monoclonal antibody, in juvenile idiopathic Arthritis-associated uveitis refractory to adalimumab.

Conditions

JIA Associated Uveitis

Keywords

Biological; Uveitis; adalimumab; golimumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants Reported as Complete Responders to Golimumab

  Response was classified as complete, partial, or none ("non-response", NR) at each timepoint separately." Complete response (CR) constituted achieving inactive uveitis, defined as 0+ cells in the AC (grade 0). Partial response (PR) was diagnosed in patients with improved uveitis, defined as a decrease in the level of inflammation, without achieving AC grade 0 status. Primary-NR was diagnosed in patients without change in SUN score and an entry grade of 3 or higher or in patients with worsening activity, defined as either a two-grade increase in inflammation or an increase in inflammation to grade 4. Relapse of uveitis was defined as active inflammation after at least 3 months of inactivity,

  last follow up, up to 5 years

Secondary Outcomes (3)

• Best Corrected Visual Acuity (BCVA)

  up to 5 years

• Number of Patients With Ocular Discomfort

  up to 5 years

• Steroid Sparing Potential

  Baseline, 12 Months Follow-Up

Study Arms (1)

group 1

All JIA patients that were switched from adalimumab to golimumab because of Treatment failure of their JIA associated uveitis at the Medical University of Graz Austria from 2010 to 2019

Drug: Golimumab

Interventions

Golimumab DRUG

subcutaneous injection

group 1

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

JIA patients at a tertiary referal Center in Graz /Austria. University setting.

You may qualify if:

• JIA associated Uveitis
• Treatment failure with adalimumab

You may not qualify if:

• Uveitis due to other causes
• Adalimumab Initiation because of non ocular reasons

Sponsors & Collaborators

• Medical University of Graz: lead

MeSH Terms

Conditions

Uveitis

Interventions

golimumab

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Results Point of Contact

• Title: PD MD Andrea Skrabl-Baumgartner
• Organization: Medical University of Graz

andrea.skrabl-baumgartner@medunigraz.at

+43 316 385

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: December 16, 2019
• Study Start: March 1, 2010
• Primary Completion: July 1, 2021
• Study Completion: August 1, 2021
• Last Updated: May 5, 2022
• Results First Posted: May 5, 2022

Record last verified: 2022-04