Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).
| Group | Value (Participants) |
|---|---|
| Acthar Gel | 7 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this research study is to evaluate the effectiveness of the study drug, ACTH Gel in people diagnosed with dermatomyositis a disease that causes muscle weakness and is associated with a rash (DM) or polymyositis (PM) a disease that causes muscle weakness without a rash. The study doctors want to evaluate whether ACTH Gel will improve the symptoms of this disease. This drug is approved by the Food and Drug Administration (FDA) for dermatomyositis (DM) and polymyositis (PM). ACTH gel has been an FDA-approved treatment for myositis since 1952, and in 2010 the FDA retained PM and DM as diseases approved for ACTH gel use.
Experimental
Acthar Gel
Acthar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. We will enroll 10 active and refractory PM/DM patients over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months. Outcome measures were not evaluated on subjects who did not reach the 8 week time point in the trial.
Outcomes the sponsor listed as primary.
Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI).
Time frame · Primary end point: IMACS preliminary definition of improvement (DOI)
3 of any of the 6 core set measures (CSM) improved by ≥ 20%, with no more than 2 CSM worsening by ≥25% (worsening measure cannot include the MMT). The DOI should be met at least once on any of the 6 follow up visits and maintained until week 24. Subjects not meeting DOI during the trial are treatment failures.
Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients.
Time frame · Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline
Mean change in glucocorticoid dose (equivalent prednisone dose) at 24 weeks compared to baseline.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (Participants) |
|---|---|
| Acthar Gel | 7 |
| Group | Value (mg) | Spread |
|---|---|---|
| Acthar Gel | 2.3 | 3.2 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Acthar GelActhar Gel (Adrenocorticotropic Hormone Gel)in refractory PM and DM patients using an open label design for 6 months. 10 active and refractory PM/DM patients were evaluated over a 15 month period, followed by 6 months of additional follow-up for each subject. Study subjects will self-administer subcutaneously H.P. Acthar Gel 80 units (1 ml) twice a week for a period of six months. | – | 3 / 10 | 7 / 10 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies that cite this trial.
1 study on this page
Indexing hint: Randomized controlled trial · 2011
Simsarian et al. 2011Drug design, development and therapycited by 27
PMID 21792296PMC3140290DOI 10.2147/dddt.s19331PUB-21792296
Indexing hint: Randomized controlled trial · 1996
Baram et al. 1996Pediatricscited by 229
PMID 8604274PMC3100715DOI 10.1542/peds.97.3.375PUB-08604274
4 studies on this page
Indexing hint: Clinical trial · 2024
Fernandez et al. 2024Rheumatology (Oxford, England)cited by 2
PMID 37941470DOI 10.1093/rheumatology/kead595PUB-37941470
Indexing hint: Clinical trial · 2018
Aggarwal et al. 2018Annals of the rheumatic diseasescited by 35
PMID 29237618DOI 10.1136/annrheumdis-2017-212047PUB-29237618
Indexing hint: Case report · 2012
Levine et al. 2012Drug design, development and therapycited by 48
PMID 22787386PMC3392138DOI 10.2147/dddt.s33110PUB-22787386
Indexing hint: Case report · 2011
Bomback et al. 2011Drug design, development and therapycited by 62
PMID 21448451PMC3063118DOI 10.2147/dddt.s17521PUB-21448451
Who could join, as posted.
PepBank is a research reference. Talk to a doctor before you use any peptide.
In PepBank now:147 peptides, 6 blends and 13 other compounds97,577 study results from 17,383 studies8,473 clinical trialsUpdated