Trial Outcomes & Findings for Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis (NCT NCT02769702)

Results Overview

standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

2 participants

Primary outcome timeframe

Baseline and 12 weeks

Results posted on

2018-10-01

Participant milestones
Measure	Acthar 80 IU Acthar 80 IU SC twice week
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Open Label Study of Acthar SQ Gel Injection in Patients With Active Anterior Uveitis

Baseline characteristics by cohort
Measure	Acthar 80 IU n=2 Participants Acthar 80 IU SC twice week
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

Timeframe: Baseline and 12 weeks

standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more cellularity.

Outcome measures
Measure	Acthar 80 IU n=2 Participants Acthar 80 IU SC twice week
Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination Baseline	0.5 units on a scale Standard Deviation 0.70
Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination 12 Weeks	1.25 units on a scale Standard Deviation 1.06

Timeframe: Baseline and 12 weeks

standard assessment of uveitis activity. Scores were assessed using a Likert scale using 0 to 4, higher score reflects more protein.

Outcome measures
Measure	Acthar 80 IU n=2 Participants Acthar 80 IU SC twice week
Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation 12 Weeks	1.0 units on a scale Standard Deviation 1.41
Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation Baseline	NA units on a scale Standard Deviation NA Score could not be determined for 1 of the 2 participants.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Washington University School of Medicine

Phone: 314-454-7255