Trial · NCT01906372
Acthar in Treatment of Refractory Dermatomyositis and Polymyositis
NCT01906372, Phase 2, Completed, Rohit Aggarwal, MD; results first posted 2017-08-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Acthar in Treatment of Refractory Dermatomyositis and Polymyositis. Trials, record NCT01906372. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01906372
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Acthar in Treatment of Refractory Dermatomyositis and Polymyositis
- NCT number
- NCT01906372
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Rohit Aggarwal, MD
- Conditions
- Dermatomyositis, Polymyositis
- Interventions
- Adrenocorticotropic Hormone Gel
- First posted
- 2013-07-24
- Last updated
- 2017-09-01
- Results first posted
- 2017-08-02
- Limitations and caveats
- Small pilot open label single arm trial. Larger double blinded placebo controlled randomized trials are required.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI). | 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. |
| Secondary | Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients. | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI). | Primary end point: IMACS preliminary definition of improvement (DOI) | Total of 10 PM/DM patients completed the study.One additional patient dropped out of the study at 6 weeks due to worsening of conduction abnormalities (heart block unrelated to the study drug).The patient had not completed minimum 8 weeks of study drug required for outcome assessment as per study protocol, and was not included in primary analysis. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients. | Steroid sparing effect and safety and tolerability at 24 weeks compared to baseline | mg | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Specific Aim 1: Number of Subjects Meeting IMACS Preliminary Definition of Improvement (DOI). | Acthar Gel | 7 | Participants | ||
| Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients. | Acthar Gel | Follow Up 24 weeks | 2.3 | Standard Deviation 3.2 | mg |
| Steroid-sparing Effect of H.P. Acthar Gel in Refractory Adult PM and DM Patients. | Acthar Gel | Baseline | 18.5 | Standard Deviation 15.7 | mg |
Source ClinicalTrials.gov
Participant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acthar Gel | 12 | |
| Overall Study | Visit 7: Treatment Phase Completed | Acthar Gel | 10 | |
| Overall Study | Visit 10: Follow up Phase Completed | Acthar Gel | 8 | |
| Overall Study | COMPLETED | Acthar Gel | 10 | |
| Overall Study | NOT COMPLETED | Acthar Gel | 2 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Sinus Tachycardia | Cardiac disorders | Acthar Gel | 1 | 10 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Acthar Gel | 1 | 10 | 1 |
| other | General disorders and administration site conditions | General disorders | Acthar Gel | 4 | 10 | 4 |
| other | Sinusitis | Infections and infestations | Acthar Gel | 1 | 10 | 1 |
| other | Upper Respiratory Infections | Infections and infestations | Acthar Gel | 1 | 10 | 1 |
| other | Cholesterol high | Metabolism and nutrition disorders | Acthar Gel | 1 | 10 | 1 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Acthar Gel | 3 | 10 | 3 |
| other | Anxiety | Psychiatric disorders | Acthar Gel | 1 | 10 | 1 |
| other | Agitation | Psychiatric disorders | Acthar Gel | 1 | 10 | 1 |
| other | Insomnia | Psychiatric disorders | Acthar Gel | 2 | 10 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acthar Gel | ||
| Total, other adverse events | Acthar Gel | 7 | 10 |
| Total, serious adverse events | Acthar Gel | 3 | 10 |
Source ClinicalTrials.gov
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01906372
GET https://conductscience.org/api/trials/v1/NCT01906372/registered