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Repository Corticotropin Injection To Treat Rheumatoid Arthritis Patients Who Have Failed Three Biologic Therapies.
Plain-language guide to NCT01966718: phase 4 interventional trial of ACTH (Corticotropin), rheumatoid arthritis, 8 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01966718
- Phase
- phase 4
- Status
- completed
- Start
- 2013-10
- Completion (planned or actual)
- 2015-10
- Participants
- 8 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Rheumatoid Arthritis
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test ACTH (Corticotropin) for rheumatoid arthritis.
It had 1 arm (groups): Repository corticotropin injection (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 8 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: On at least third biologic with a different mechanism of action for at least 12 weeks. Active disease as defined by at least 6 tender and 6 swollen joints. Erythrocyte sedimentation rate (ESR) at least 28 mm/hr or C-reactive protein (CRP) at least 1.2 times the upper limit of normal.
The full record lists 5 inclusion and 4 exclusion criteria; among the exclusions: history of intolerance or allergy to glucocorticoids; unstable diabetes; active infection.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label ACTH (Corticotropin) study: the rheumatoid arthritis participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2013-10 with completion listed for 2015-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Change From Baseline in the Ritchey-Camp Articular Index (time frame: From baseline to week 16). Change From Baseline in the 20-item Health Assessment Questionnaire Score (time frame: From baseline to week 16).
It also tracked 2 secondary outcomes, for example Change From Baseline in the Erythrocyte Sedimentation Rate (ESR) and Change From Baseline in the C-Reactive Protein (CRP) Level.
What This Means in Plain Language
Put simply, this is a phase 4 trial of ACTH (Corticotropin) in 8 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.
Our Notes on the Compound
ACTH (Corticotropin): The 39-amino-acid pituitary hormone that drives cortisol production; given as repository corticotropin (Acthar Gel).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.