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Open-label Trial of Acthar Gel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus

NCT01769937 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2013-07-23

No results posted yet for this study

Summary

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.

Conditions

  • Lupus Erythematosus Systemic Exacerbation

Interventions

DRUG

H.P. Acthar Gel

Open-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing

Sponsors & Collaborators

  • Fiechtner, Justus J., M.D., P.C.

    lead INDIV

Principal Investigators

  • Justus J Fiechtner, MD, MPH · Justus J. Fiechtner, MD, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01769937 on ClinicalTrials.gov