ACTHAR for Acute Treatment of Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate

What Was Tested

The trial (phase 2) is built around ACTH (Corticotropin) for rheumatoid arthritis.

It had two arms (groups): Four week ACTHAR treatment (experimental) and Twelve week ACTHAR treatment (experimental).

The registry classes the interventions as drug.

More on the Plan

The standard treatment for rheumatoid arthritis is using disease-modifying anti-rheumatic drugs such as methotrexate to control joint pain and swelling.

Often times rheumatoid arthritis patients experience inadequate response to methotrexate with acute or persistent joint pain and swelling.

In these patients, alternative or additional immunosuppressive therapy is needed to induce disease remission.

Who Took Part

Enrollment: 15 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Male or female at least 18 years of age at the time of screening. Subject is diagnosed with RA no less than 6 months prior to the screening. Subject meets the 2010 ACR/EULAR Classification Criteria for RA (Arthritis Rheum 2010:62;2569-2581) with a score of ≥6. Subject is seropositive for RF and/or anti-CCP antibodies as part of the diagnostic criteria for RA. Subject has moderately to severely active RA during screening, as defined by a DAS28-ESR \> 3.2.

The full record lists 7 inclusion and 26 exclusion criteria; among the exclusions: treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of screening; treatment with any biological agents within 4 weeks (or 5 half-lives of the agent, whichever is longer) of screening; immunization with a live/attenuated vaccine within 4 weeks prior to baseline.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

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.

In this single-blind ACTH (Corticotropin) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2014-06-23 with completion listed for 2016-09-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Adverse Events.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of ACTH (Corticotropin) in 15 people with rheumatoid arthritis.

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

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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