Acthar Gel (repository corticotropin injection) for persistently active SLE: study design and baseline characteristics from a multicentre, randomised, double-blind, placebo-controlled trial

What Was Tested

This clinical study looks at ACTH (Corticotropin).

SLE is a chronic inflammatory autoimmune disease characterised by the excessive production of autoantibodies, immune complexes and proinflammatory cytokines.

Repository corticotropin injection (RCI) is a naturally sourced complex mixture of adrenocorticotropic hormone analogues and other pituitary peptides.

RCI is approved by the US Food and Drug Administration for use during an exacerbation or as maintenance therapy in select cases of SLE.

Who Took Part

PubMed indexes the participants as adults, both men and women.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and multicenter study.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received ACTH (Corticotropin).

The comparison arm used a placebo, so changes seen with ACTH (Corticotropin) could be set against what happens without it.

More than one site took part, so the participants came from several places.

The safety and tolerability profile of RCI will also be evaluated through adverse event profiles, physical examination, clinical laboratory tests and serum cortisol levels.

What Was Measured

The subject headings attached to it are Adrenocorticotropic Hormone, Anti-Inflammatory Agents, Autoantibodies, Autoimmune Diseases, Biomarkers, Disease Progression and Hormones.

The authors tagged it with the keywords SLE, corticosteroids and inflammation.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of ACTH (Corticotropin).

The abstract goes on to report its results in about 4 sentences; this page does not restate them, so read the paper for the findings and their limits.

The publication is from 2020 (Lupus science & medicine), a journal based in England.

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