Use of Acthar in Rheumatoid Arthritis (RA) Related Flares

What Was Tested

The trial (phase 4) is built around ACTH (Corticotropin) for rheumatoid arthritis.

This is a Rheumatoid Arthritis (RA) study.

It had two arms (groups): one (active comparator) and one (active comparator).

The registry classes the interventions as drug.

More on the Plan

Both arms will be taking the drug for 4 weeks.

Each participant will be coming back for visits at 2 weeks, 1 month and 3 months after the initial baseline visit.

During these visits the following information will be collected: MSUS of joints, DAS28, and Health Assessment Questionnaire-Disability Index (HAQ-DI).

Participants will also be asked to fill out a questionnaire about their health status.

Who Took Part

The registry lists 40 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: Patient must meet 1987 ACR criteria. Age \> 18 years of age. Baseline DAS28/Erythrocyte Sedimentation Rate (ESR) \>=3.2. Stable concomitant Disease Modifying Anti-Rheumatic Drugs (DMARDs). Power Doppler score of \>=10.

The full record lists 6 inclusion and 3 exclusion criteria; among the exclusions: prior treatment with acthar in the past 2mos; meet one of the above ra flare requirements.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

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

Groups ran in parallel: each of the rheumatoid arthritis participants stayed in one arm throughout.

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

It started in 2017-07-20 with completion listed for 2025-05-06.

It ran at 1 site in United States.

Its stated primary purpose is diagnostic.

What Was Measured

The main thing measured (primary outcome): DAS28 (time frame: Baseline to 4 Weeks). Power Doppler Ultrasound Score (time frame: Baseline to 4 Weeks).

It also tracked 2 secondary outcomes, for example Ultrasound Grey Scale Synovial Hypertrophy Score and HAQ-DI.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 40 people with rheumatoid arthritis.

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.