The Effect of Corticotrophin (ACTH) in Combination With Methotrexate in Newly Diagnosed Rheumatoid Arthritis Patients

What Was Tested

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

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

The registry classes the interventions as drug.

More on the Plan

Acthar Gel Respository Injection, Corticotrophin( ACTH) administered to newly diagnosed patients with rheumatoid arthritis in conjunction with methotrexate, folllowed by a 24 week follow-up period.

There will be a total of twenty (20) patients and two (2) treatment groups with 10 patients in each treatment group.

Who Took Part

Enrollment: 20 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 be at least 18 years old at the screening visit. Patient must be able to understand the information provided to them and to give written Informed Consent. A Baseline Magnetic Resonance Imaging ( MRI) must show the presence of osteitis or erosions in the hand or wrist. Patients must be able and willing to comply with the requirements of the study protocol. Patients must have a C-reactive Protein (CRP) or erythrocyte sedimentation rate (ESR) \> upper limits of normal.

The full record lists 8 inclusion and 13 exclusion criteria; among the exclusions: patients who have a diagnosis of any other inflammatory arthritis (e.g., psoriatic arthritis or ankylosing spondylitis); patients with exposure to any disease modifying antirheumatic drug (dmard), biologic, non-biologic or experimental medication for the treatment of rheumatoid arthritis (ra); patients with history of an infected joint prosthesis at any time with that prosthesis still in situ.

How the Study Was Run

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

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.

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

It started in 2013-09 with completion listed for 2016-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change From Baseline in Clinical Disease Activity Index (CDAI) Score (time frame: Baseline, Month 3 and Month 6).

It also tracked 3 secondary outcomes, for example Comparison of Clinical Disease Activity Index (CDAI) Scores to Positive Magnetic Resonance Imaging (MRI) Findings.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of ACTH (Corticotropin) in 20 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.