Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

What Was Tested

This registered phase 4 trial tested ACTH (Corticotropin) for lupus (sle).

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE).

The doctor will assign eligible patients to one of two groups (like flipping a coin).

Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it.

It had two arms (groups): Acthar Gel (experimental) and Placebo Gel (placebo comparator).

Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks.

Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks.

The registry classes the interventions as drug.

More on the Plan

This trial was initiated (started recruiting) in October 2016, but first patient was not enrolled (randomized) until December, 2016.

Who Took Part

Enrollment: 172 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: Have a diagnosis of SLE according to 4 of the American College of Rheumatology revised criteria. Have active SLE. Have a documented history or screening result of. Positive antinuclear antibody (ANA), OR. Elevated anti-dsDNA or extractable nuclear antigen (ENA) antibodies.

The full record lists 9 inclusion and 3 exclusion criteria; among the exclusions: has a history of sensitivity to adrenocorticotropic hormone (acth) preparations or porcine products; has active lupus nephritis; has active central nervous system (cns) manifestations of sle.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

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.

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

Those kept unaware of assignments: participant and investigator.

It started in 2016-12-16 with completion listed for 2019-07-31.

It ran at 39 sites in United States (16), Mexico (15), Peru (4), Argentina (3) and Chile (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Physician's Global Assessment (PGA) (time frame: Baseline, Week 16, Week 24). British Isles Lupus Assessment Group 2004 (BILAG 2004) (time frame: Baseline, Week 16, Week 24). Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) (time frame: Week 16, Week 24).

It also tracked 4 secondary outcomes, for example Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16, Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score and Mean Number of Swollen or Tender Joints on the 28-Joint Count.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 172 people with lupus (sle).

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.