Safety and Effectiveness of Acthar Gel in Participants With Rheumatoid Arthritis

What Was Tested

In this phase 4 trial, researchers set out to test ACTH (Corticotropin) for rheumatoid arthritis.

This is a 2-part study to examine the effect of Acthar Gel in adult participants with rheumatoid arthritis (RA) with persistently active disease even after receiving two other treatments intended to modify the disease.

Part 1 is an Open Label Period in which all eligible participants receive Acthar Gel for 12 weeks.

After these 12 weeks of treatment with Acthar Gel, participants will be evaluated for treatment response using the DAS28-ESR.

It had three arms (groups): Part 1: All Enrolled Participants (experimental), Part 2: Acthar Gel (experimental) and Part 2: Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 259 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: Male or nonpregnant, nonlactating female subjects. Meets criteria for definite rheumatoid arthritis as defined by 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification at screening. Has active disease defined as a score of \>3.2 on DAS28-ESR prior to study drug administration despite dual-DMARD treatment.

The full record lists 5 inclusion and 6 exclusion criteria; among the exclusions: has current rheumatoid disease or inflammatory joint disease other than ra; has any history of use of adrenocorticotropic hormone (acth) for the treatment of ra; has taken b-cell mediated therapies in the 6 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and double-blind.

Because people in this ACTH (Corticotropin) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the rheumatoid arthritis participants and researchers unaware of who received ACTH (Corticotropin).

Those kept unaware of assignments: participant and investigator.

It started in 2016-11-07 with completion listed for 2018-10-17.

It ran at 59 sites in United States (30), Mexico (18), Peru (6), Argentina (4) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Part 1: Number of Participants With Low Disease Activity (LDA) by Visit (time frame: Baseline to Week 12). Part 2: Number of Participants Who Maintained Low Disease Activity by Visit (time frame: Week 12 to Week 24).

It also tracked 12 secondary outcomes, for example Part 1: Swollen Joint Count by Visit, Part 2: Swollen Joint Count by Visit During Part 2, Part 1: Tender Joint Count by Visit, Part 2: Tender Joint Count by Visit, Part 1: Patient-Reported General Health by Visit and Part 2: Patient-Reported General Health by Visit.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 259 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.