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NCT01769937: ACTH
A Single-site, Investigator Initiated Open-Label Trial of H.P. Acthar Gel (Repository Corticotropin Injection)an Adrenocorticotropic Hormone (ACTH) Analogue in Subjects With Moderately to Severely Active Systemic Lupus Erythematosus (SLE)
Phase 4 trial testing H.P. Acthar Gel in Lupus Erythematosus Systemic Exacerbation in 10 participants. Completed in 1 April 2013.
1 April 2013
Quick facts
| Lead sponsor | Fiechtner, Justus J., M.D., P.C. |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 1 October 2012 |
| Primary completion | 1 April 2013 |
| Estimated completion | 1 April 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- H.P. Acthar Gel (REPOSITORY CORTICOTROPIN) — full drug profile →
Conditions studied
- Lupus Erythematosus Systemic Exacerbation — all drugs for Lupus Erythematosus Systemic Exacerbation →
Sponsor
Fiechtner, Justus J., M.D., P.C. — full company profile →
Who can join
Adults 18 to 75, any sex, with Lupus Erythematosus Systemic Exacerbation. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
SLEDAI-2K score
Time frame: 14 days
The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
Sponsor's own description
Systemic lupus erythematosus is a serious and potentially life-threatening condition with significant unmet medical need. The aim of this Investigator Initiated, single center, open-label study is to evaluate the efficacy and safety of a daily subcutaneously (SQ) injection of H.P. Acthar Gel for 10 days with an optional 5 day rescue period for non-responders after day 10 dose. The primary objective of this study is to evaluate whether the addition of H.P. Acthar Gel to standard treatment of lupus will ameliorate the intensity of flares as measured by changes in SLEDAI score, Patient and Physician global assessments.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01769937
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of H.P. Acthar Gel
Trials testing the same drug.
- NCT02245841 — Efficacy and Safety of H.P. Acthar Gel for the Treatment of Refractory Cutaneous Manifestations of Dermatomyositis · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01769937 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Fiechtner, Justus J., M.D., P.C.
- Last refreshed: 22 July 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01769937.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing