Acthar for the Treatment of Systemic Lupus Erythematosus (SLE) in Patients With a History of Persistently Active Disease

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin) for lupus (sle).

This Phase 4 study is being performed to examine the effects of Acthar for the indicated use of treatment of SLE.

This study will enroll patients with steroid-dependent, persistently active SLE with arthritic and/or cutaneous involvement.

It had four arms (groups): Period 2: Placebo/Acthar (experimental), Period 2: Acthar/Acthar (experimental), Period 1: Placebo (placebo comparator) and Period 1: Acthar (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 38 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: Male or female ≥ 18 years of age at screening who are able to provide informed consent. Diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled ≥ 4 criteria). Documented history of autoantibodies to at least one of the following: anti-dsDNA, anti-Smith, or anti-cardiolipin. Documented history of positive antinuclear antibody (ANA).

The full record lists 7 inclusion and 13 exclusion criteria; among the exclusions: patients with a recent history (≤ 2 months prior to screening) of starting prednisone (or equivalent) use; type 1 or type 2 diabetes mellitus (history of gestational diabetes mellitus is not an exclusion), or patients currently taking hypoglycemic medication; history of using certain medications prior to screening:.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind 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.

The ACTH (Corticotropin) group and the comparison group ran side by side rather than switching.

Neither the lupus (sle) participants nor the staff measuring them knew who was on ACTH (Corticotropin), so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2013-01 with completion listed for 2015-10.

It ran at 22 sites in United States (22).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Participants Who Meet the Definition of a Responder Within 4 Weeks (time frame: within 4 weeks).

It also tracked 20 secondary outcomes, for example Number of Participants Who Meet the Definition of a Responder Within 8 Weeks, Score on the SELENA-SLEDAI Within 8 Weeks, BILAG Total Score Within 8 Weeks, Physician's Global Assessment (PGA) of Disease Severity at Baseline, Physician's Global Assessment (PGA) of Disease Severity at Week 4 and Physician's Global Assessment (PGA) of Disease Severity at Week 8.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 38 people with lupus (sle).

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

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the ACTH (Corticotropin) compound page, Lupus (SLE) research.