ACTHar in the Treatment of Lupus Nephritis

What Was Tested

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

Systemic Lupus Erythematosus (SLE) is a disease in which the immune system attacks the healthy cells and tissues, causing inflammation that can damage organs in the body.

It had two arms (groups): CellCept daily & ACTHar gel biw (active comparator) and CellCept daily & ACTHar gel qod (active comparator).

The registry classes the interventions as drug.

More on the Plan

Systemic Lupus Erythematosus (SLE) is an autoimmune disease of unknown etiology that mainly affects females of childbearing age.

The disease is characterized by immune activation and the development of autoantibodies.

Lupus Nephritis (LN) is a major cause of morbidity and mortality in patients with SLE.

Mycophenolate Mofetil (MMF), accompanied by Prednisone, is considered the current standard of care for LN.

Who Took Part

The registry lists 8 actual participants took part.

It was open to people of any sex aged from 16 years with no upper age limit.

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

Examples of who could join: Diagnosis of Systemic Lupus Erythematosus (SLE) by American College of Rheumatology (ACR)/SLICC criteria. Age ≥ 16 years. Active lupus nephritis defined by:. Ability to provide informed consent.

The full record lists 4 inclusion and 18 exclusion criteria; among the exclusions: neutropenia (\< 1,000/mm3); thrombocytopenia (platelets \< 50,000/mm3); positive purified protein derivative (ppd) test confirmed by positive quantiferon tb gold.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Everyone knew when ACTH (Corticotropin) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2014-10 with completion listed for 2024-01-03.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Number of Patients With a Complete Response (CR) (time frame: 6 Months).

It also tracked 4 secondary outcomes, for example Number of Responders, Number of Patients With Extra-renal Flares, Number of Patients With Steroid -Like Side Effects and Number of Patients With Side Effects.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 8 people with lupus (sle).

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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