Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

What Was Tested

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

It had 1 arm (groups): H.P. Acthar Gel SQ injection (experimental).

The registry classes the interventions as drug.

More on the Plan

This is a Phase 4 Open-label Study to Evaluate the Treatment of Lupus Flares with H.P.

The primary objective is to evaluate whether the addition of H.P.

The secondary objective is to evaluate any changes to the subjects BILAG scores and markers of inflammation, e.g.

The Exploratory objective will determine the feasibility of a long-term double-blind study using H.P.

Who Took Part

The registry lists 10 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Age 18-75 years at the time of screening. Written informed consent and any locally required authorization (eg. HIPAA) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations. Fulfills at least 4 of the 11 American College of Rheumatology (ACR) classification criteria for SLE, including a history of ANA positivity. Diagnosis of pediatric or adult SLE with chronic disease activity requiring ongoing treatment or observation for \> 8 weeks prior to screening. Currently receiving at least one of the following:.

The full record lists 10 inclusion and 11 exclusion criteria; among the exclusions: employees of the clinical study site or any other individuals involved with the conduct of the study or immediate family members of such individuals; A known history of allergy or reaction to any component of the investigational product; any live or attenuated vaccine within 4 weeks (28 days) prior to signing the informed consent form (administration of killed vaccines is acceptable).

How the Study Was Run

Design: single-group and open-label.

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.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2012-10 with completion listed for 2013-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: SLEDAI-2K score (time frame: 14 days).

It also tracked 1 secondary outcome, for example BILAG-2004.

What This Means in Plain Language

Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 10 people with lupus (sle).

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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