drugset / Trial / NCT01049451
Pulse ACTH vs. MP for MS
RandomizedParallel-groupSingle-blindTreatment
Summary
We hypothesize that corticotropin or adrenocorticotrophic hormone (ACTH), administered as Acthar Gel® (MANUFACTURER NAME) is effective in the control of clinical disease activity as a pulse therapy for relapsing-remitting MS when added to standard treatment with beta-interferon. We wish to determine whether ACTH, when administered as clustered monthly intramuscular injections (monthly pulse therapy) as add-on to beta-interferons, may be a safe and effective alternative to monthly pulse therapy with MP. In addition, we hypothesize that pulse therapy with ACTH alters immune function to favor a regulatory, rather than a pro-inflammatory T cell environment.
Timeline
- Start
- 2009-11
- Primary completion
- 2013-06
- Completion
- 2013-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ACTH | Unknown | 80 iu | Intramuscular |
| Comparator | Methylprednisolone | Other / unclassified | 1 g | Intravenous |