Protocol for H.P. Acthar Gel in Moderately to Severely Active Psoriatic Arthritis

What Was Tested

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

Psoriatic arthritis is a heterogeneous chronic inflammatory disorder involving joints, tendon sheaths, entheses, and the axial skeleton as well as skin and nails.

This is an open-label trial with H.P.

It had 1 arm (groups): H.P. Acthar Gel SQ injection (experimental).

The registry classes the interventions as drug.

More on the Plan

The subjects in this study will be adult men and women ages 18-75 years of age at the time of screening with chronic, moderately-to-severely active PsA and meeting ACR criteria.

Who Took Part

Enrollment: 10 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years at the time of screening. Written informed consent and any locally required authorization (e.g. HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months. Subject must have \> 6 tender and \>6 swollen joint count at screening. Subject must have \> 30 minutes of morning joint stiffness.

The full record lists 14 inclusion and 11 exclusion criteria; among the exclusions: subject has a planned surgical intervention between baseline and the week 24 evaluation; subject has a diagnosis of scleroderma, osteoporosis, fungal infections or ocular herpes simplex; history of any type of malignancy \<5 years before enrollment into the study (apart from basal cell carcinoma).

How the Study Was Run

It was run as a non-randomized, 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 2013-07 with completion listed for 2014-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: ACR20 (American College of Rheumatology 20) (time frame: Week 12).

It also tracked 1 secondary outcome, for example Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized 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.

Its status is unknown; 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.