Addition of H.P. Acthar Gel to Treatment Regimen of Patients With Rheumatoid Arthritis

What Was Tested

This registered not phased trial tested ACTH (Corticotropin) for rheumatoid arthritis.

This will be a 20 week, prospective, multicenter, open-label study conducted at 3-4 university/medical centers and private practice settings in the US.

The registry classes the interventions as drug.

Who Took Part

The registry lists 10 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: ≥ 18 years of age at the time of participation. Have a confirmed diagnosis of RA based on the 2010 ACR/EULAR criteria. Tuberculosis has not occurred within the recent past, as proven by a conventional x-ray, negative tuberculosis shin test (PPD), or quantiferon gold.

The full record lists 5 inclusion and 19 exclusion criteria; among the exclusions: presence of any condition which could confound interpretation of the data, such as inflammatory arthritis (eg. psoriatic arthritis, gout or pseudogout); presence of systemic fungal infections, recent surgery (within prior 3 months), or active ulcer disease (within the past 5 years); current symptoms of severe, progressive, or uncontrolled renal, hepatic ,hematologic, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease.

How the Study Was Run

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

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

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

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

It started in 2014-02 with completion listed for 2015-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of ACTH (Corticotropin) in 10 people with rheumatoid arthritis.

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

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the ACTH (Corticotropin) compound page, Rheumatoid arthritis research.