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

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin).

Uveitis is an acute or chronic inflammatory condition of unknown etiology.

Although uveitis often responds adequately to topical corticosteroids, there are many patients for which this treatment is either inadequate or not tolerated.

A patient with inadequate response to treatment would manifest uveitis activity by slit lamp examination determination of anterior chamber cellularity.

It had 1 arm (groups): Intervention (experimental).

The registry classes the interventions as drug.

More on the Plan

Patients eligible for the study will be identified by the investigators and given a copy of the consent form to read.

Patients interested in enrolling will be screened and if eligible will be enrolled in the study.

The screening visit and the baseline visit may occur on the same day.

Patients will keep an injection log which will be inspected at each visit (4, 8, and 12 weeks).

Who Took Part

2 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Active anterior uveitis requiring oral and/or topical corticosteroid therapy.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: uncontrolled diabetes; uncontrolled glaucoma; HIV infection or other infection for which corticosteroid therapy contraindicated.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2016-06 with completion listed for 2017-01-06.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change From Baseline in Eye With Uveitis of Anterior Chamber Cellularity Graded From 0-4 on a Likert Scale Determined by Slit Lamp Examination (time frame: Baseline and 12 weeks).

It also tracked 1 secondary outcome, for example Change in Baseline in Eye With Uveitis of Anterior Chamber Protein Graded 0-4 on a Likert Scale Determined by Slit Lamp Evaluation.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 2 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the ACTH (Corticotropin) compound page, all human trials.