ACTH Gel Therapy in Rheumatoid Arthritis

What Was Tested

In this not phased trial, researchers set out to test ACTH (Corticotropin) for rheumatoid arthritis.

ACTH gel has been a Food and Drug Administration-approved treatment for Rheumatoid Arthritis since 1952, and in 2010 the FDA retained RA as a disease approved for ACTH gel use.

It had 1 arm (groups): ACTHAR Gel (other).

The registry classes the interventions as drug.

More on the Plan

This study is for people who are currently taking a biologic therapy for Rheumatoid Arthritis and who are still experiencing symptoms.

Subjects are given the ACTH gel to take twice each week for 12 weeks as a supplement to current therapies.

Subjects are required to visit the clinic for a baseline visit, at 2 weeks, 4 weeks, 8 weeks and 12 weeks.

The researchers will obtain a blood sample for research purposes.

Who Took Part

The registry lists 18 actual participants took part.

It was open to people of any sex aged from 18 years up to 100 years.

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

Examples of who could join: 18 year of age and older. RA diagnosis by American College of Rheumatology criteria. Active disease (CDAI \> 10). Have received at least are biologic agent for at least 6 months. No current active infections requiring antibiotics.

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: less than 18 years of age; unable or unwilling to give informed consent; have an active infection requiring the use of antibiotics.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the ACTH (Corticotropin) study did not mask who received what.

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

It started in 2014-11 with completion listed for 2022-06-30.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Changes in Clinical Disease Activity Index (CDAI) Between Week 0 and Week 12 (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Change in the Disease Activity Score (DAS28-CRP) Between Week 0 and Week 12, Changes in Acute Phase Reactants (CRP) Between Week 0 and Week 12, Change in Acute Phase Reactants (ESR) Between Week 0 and Week 12 and Patient Reported Changes in Fatigue Between Week 0 and Week 12.

What This Means in Plain Language

Put simply, this is a not phased trial of ACTH (Corticotropin) in 18 people with rheumatoid arthritis.

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

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, Rheumatoid arthritis research.