Trial Outcomes & Findings for Golimumab in Juvenile Idiopathic Arthritis-associated Uveitis Failing Adalimumab (NCT NCT04200833)

NCT ID: NCT04200833

Last Updated: 2022-05-05

Results Overview

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,

• Recruitment status: COMPLETED
• Target enrollment: 10 participants
• Primary outcome timeframe: last follow up, up to 5 years
• Results posted on: 2022-05-05

Participant Flow

Participant milestones

Measure	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 Golimumab: subcutaneous injection
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Group 1 n=10 Participants 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 Golimumab: subcutaneous injection
Age, Categorical <=18 years	9 Participants n=10 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=10 Participants
Age, Categorical >=65 years	0 Participants n=10 Participants
Age, Continuous	14.0 years STANDARD_DEVIATION 6.4 • n=10 Participants
Sex: Female, Male Female	10 Participants n=10 Participants
Sex: Female, Male Male	0 Participants n=10 Participants
Region of Enrollment Austria	10 participants n=10 Participants

PRIMARY outcome

Timeframe: last follow up, up to 5 years

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,

Outcome measures

Measure	Group 1 n=10 Participants 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 Golimumab: subcutaneous injection
Number of Participants Reported as Complete Responders to Golimumab	8 Participants

SECONDARY outcome

Timeframe: up to 5 years

best corrected visual acuity

Outcome measures

Measure	Group 1 n=10 Participants 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 Golimumab: subcutaneous injection
Best Corrected Visual Acuity (BCVA)	0.27 LogMAR Standard Deviation 0.33

SECONDARY outcome

Timeframe: up to 5 years

eye soreness, photophobia

Outcome measures

Measure	Group 1 n=10 Participants 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 Golimumab: subcutaneous injection
Number of Patients With Ocular Discomfort	0 Participants

SECONDARY outcome

Timeframe: Baseline, 12 Months Follow-Up

Reduction in systemic steroid dose at the 12 month follow-up compared to baseline

Outcome measures

Measure	Group 1 n=10 Participants 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 Golimumab: subcutaneous injection
Steroid Sparing Potential	0.19 mg/kg per day Interval 0.0 to 0.52

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

PD MD Andrea Skrabl-Baumgartner

Medical University of Graz

Phone: +43 316 385

Email: andrea.skrabl-baumgartner@medunigraz.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place