Acthar SLE (Systemic Lupus Erythematosus)

What Was Tested

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

It had two arms (groups): one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Acthar is currently labeled for use during an exacerbation or for maintenance therapy in selected SLE cases, however data from prospective trials on hematologic manifestations of SLE are not available.

Due to the potential effect of lowering or eliminating autoantibodies, the absence of bone marrow suppression, and a steroid sparing effect, Acthar may represent a novel therapeutic option in recalcitrant cases of hematologic SLE.

Who 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: Able to provide informed consent. Diagnosis of SLE according to the American College of Rheumatology revised criteria (fulfilled ≥ 4 criteria). Ability to comply with study procedures, which include SC injections of study medication, adhering to concomitant medication restrictions, and attending scheduled office visits.

The full record lists 6 inclusion and 21 exclusion criteria; among the exclusions: patients with a recent history (\< 2 week prior to screening) of starting prednisone or equivalent; type 1 or type 2 diabetes mellitus (history of gestational diabetes is not an exclusion), or patients currently taking hypoglycemic medication; patients with a history of concomitant medication use as follows:.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

Groups ran in parallel: each of the lupus (sle) participants stayed in one arm throughout.

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

It started in 2016-10 with completion listed for 2019-05-22.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) Score (time frame: Baseline to Week 24). British Isles Lupus Assessment Group (BILAG) disease activity index Score (time frame: Baseline to Week 24). Physician's Global Assessment Score (time frame: Baseline to Week 24).

It also tracked 3 secondary outcomes, for example Medical Outcomes Survey Short Form-36, FACIT Fatigue Scale and Patient's Global Assessment.

What This Means in Plain Language

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

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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