Efficacy, Radiographic and Laboratory Changes in Refractory Rheumatoid Arthritis Patients Treated With H.P. Acthar Gel

What Was Tested

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

This study will examine the clinical response, cytokine expression and joint imaging after addition of Acthar Gel.

The hypothesis is that H.P.

It had two arms (groups): Group A (active comparator) and Group B (active comparator).

The registry classes the interventions as drug.

More on the Plan

Rheumatoid arthritis (RA) is a systemic inflammatory disease which causes premature mortality, disability and compromised quality of life in the industrialized and developing world.

Despite available treatment options for RA, some patients still have disease that is refractory to treatment and cannot achieve remission.

Acthar gel (adrenocorticotropic hormone gel) received FDA approval for treatment of a variety of diseases, including RA in 1952.

Acthar gel has been attributed to its ability to induce production of endogenous steroids and to bind melanocortin receptors on lymphocytes and other cells to modulate immunologic responses.

Who Took Part

30 planned participants were the target.

It was open to people of any sex aged from 21 years with no upper age limit.

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

Examples of who could join: Fluent in reading and writing in English language. ≥ 21 years of age at the time of participation.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: previous use of acth preparations for treatment of nephrotic syndrome (including but not limited to h.p. acthar gel and synacthen®); previous history of sensitivity to acth preparations (including but not limited to h.p. acthar gel and synacthen®); previous history of sensitivity to porcine protein products.

How the Study Was Run

The set-up was randomized, crossover and open-label.

The rheumatoid arthritis participants were allocated by chance, so the ACTH (Corticotropin) group and the comparison group should start out alike.

Each person switched between ACTH (Corticotropin) and the comparison at some point, usually with a gap in between.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

It started in 2017-03-03 with completion listed for 2018-02.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): ACR 20 response ACR 20 response (time frame: Baseline to week 12).

It also tracked 9 secondary outcomes, for example ACR 50 response, ACR 70 response, EULAR moderate response, EULAR good response, Resolution of Powered Doppler Signal of MSKUS studies and Resolution of signs of active inflammation in MRI.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 30 people with rheumatoid 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, Rheumatoid arthritis research.