Clinical Impact of Acthar in the Psoriatic Arthritis Patient (CLIPS)

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin) for psoriasis and psoriatic arthritis.

It had 1 arm (groups): Treatment arm (other).

Treatment arm for 12 weeks followed by observation period of 12 weeks, and a bone density at week 52.

The registry classes the interventions as drug.

More on the Plan

Secondary Outcome Measures: Secondary Imaging Endpoints 1\.

Who Took Part

The registry lists 10 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: Signed written informed consent before any study-related procedure is undertaken that is not part of the standard subject management. Subjects are willing to comply with the structure of the study, such as visits, treatment plan, laboratory and imaging studies. Tender/painful joints on motion (out of 68 joints assessed); and;. Previous use of DMARDS:. Intrauterine hormone-releasing system,.

The full record lists 17 inclusion and 26 exclusion criteria; among the exclusions: other forms of psoriasis than plaque psoriasis; any person in direct relation to the study site such as employees or family members; breast feeding females, pregnant females or women in childbearing age not using adequate contraception.

How the Study Was Run

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

Nothing was hidden in this open-label ACTH (Corticotropin) study: the psoriasis and psoriatic arthritis participants and staff both knew the treatment.

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

It started in 2018-07-20 with completion listed for 2021-08-25.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary Clinical Endpoint (time frame: 12 weeks). Primary Imaging Endpoints (time frame: baseline to week 24).

It also tracked 1 secondary outcome, for example Secondary Imaging Endpoints.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 10 people with psoriasis and psoriatic arthritis.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Psoriasis and psoriatic arthritis research.