Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 4

Acthar Gel for Active Systemic Lupus Erythematosus (SLE)

NCT02953821 · View on ClinicalTrials.gov ↗

Study Summary

This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which looks like Acthar Gel, but has no medicine in it. The doctor or his staff will take measurements and ask questions to: * see how well the gel is working * see how safe it is for patients with SLE

Interventions

  • DRUG Placebo Gel
  • DRUG Acthar Gel

Study Locations (20)

Florida

  • Center for Rheumatology Immunology and Arthritis — Fort Lauderdale
  • San Marcus Research Clinic — Miami
  • Advanced Pharma CR — Miami
  • Millennium Research — Ormond Beach

Other

  • Aprillus Asistencia e Investigación — Buenos Aires
  • Consultorios Médicos Dr. Catalán Pellet — Buenos Aires
  • Centro Medico Privado de Reumatología — San Miguel de Tucumán
  • Biomedica Research Group — Santiago

California

  • C.V. Mehta MD Medical Corporation — Hemet
  • Inland Rheumatology Clinical Trials — Upland

Tennessee

  • West Tennessee Physicians' Alliance — Jackson
  • Office of Ramesh C. Gupta, MD — Memphis

Texas

  • Accurate Clinical Research — Houston
  • Sun Research Institute — San Antonio

Nevada

  • Office of George Timothy Kelly MD — Las Vegas

New York

  • NewYork-Presbyterian Columbia University Medical Center — New York

North Carolina

  • DJL Clinical Research — Charlotte

Trial Details

FieldValue
Enrollment Target 172 participants
Start Date 2016-12-16
Est. Completion 2019-10-25
Phase Phase 4

Sponsor

Mallinckrodt

11 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02953821

The ClinicalTrials.gov registry entry for NCT02953821 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 172 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 11 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lupus Erythematosus, Systemic appearing as the primary indexed condition, and to 2 interventions — of which Placebo Gel is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02953821 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, Other, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02953821 about?

NCT02953821 is a clinical study titled "Acthar Gel for Active Systemic Lupus Erythematosus (SLE)". This trial is to study Acthar Gel in participants with active systemic lupus erythematosus (SLE). The doctor will assign eligible patients to one of two groups (like flipping a coin). Participants will receive the treatment assigned to their group for 24 weeks: * Acthar Gel * Placebo Gel, which l...

What is the current status of trial NCT02953821?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 172 participants. The study started on 2016-12-16. Estimated completion is 2019-10-25.

What conditions does trial NCT02953821 study?

This clinical trial studies the following conditions: Lupus Erythematosus, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02953821?

The interventions under investigation include: Placebo Gel (DRUG), Acthar Gel (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02953821?

This trial is sponsored by Mallinckrodt, which has 11 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02953821 being conducted?

This trial has 20 study locations across California, Florida, Nevada, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial