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

COMPLETED Phase 3

Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)

NCT02728752 · View on ClinicalTrials.gov ↗

Study Summary

Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

Conditions Studied

Interventions

  • OTHER Placebo
  • DRUG Octagam 10%

Study Locations (20)

Florida

  • Octapharma Research Site — Orlando
  • NeuroMedical Research Center — Panama City
  • Octapharma Research Site — Plantation
  • University of South Florida — Tampa

California

  • Octapharma Research Site — Huntington Beach
  • Octapharma Research Site — Los Angeles
  • University of California -Irvine — Orange

Texas

  • Austin Neuromuscular Center — Austin
  • Octapharma Research Site — Houston
  • Arthritis & Osteoporosis Clinic — Waco

Other

  • Revmatologický ústav — Prague
  • Charité-Universitätsmedizin Berlin, Klinik für Dermatologie, Venerologie und Allergologie — Berlin

Kansas

  • Octapharma Research Site — Kansas City

Michigan

  • Octapharma Research Site — Ann Arbor

Minnesota

  • Octapharma Research Site — Rochester

New York

  • Octapharma Research Site — Great Neck

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2017-02-27
Est. Completion 2019-11-05
Phase Phase 3

Sponsor

Octapharma

73 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02728752

The ClinicalTrials.gov registry entry for NCT02728752 describes a study currently listed as completed. It is categorized as Phase 3, 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 95 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Octapharma, which has 73 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 Dermatomyositis appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT02728752 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, California, Texas. 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 NCT02728752 about?

NCT02728752 is a clinical study titled "Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis (Idiopathic Inflammatory Myopathy)". Prospective, Double-blind, Randomized, Placebo-Controlled Phase III Study Evaluating Efficacy and Safety of Octagam 10% in Patients With Dermatomyositis ("ProDERM study")

What is the current status of trial NCT02728752?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 95 participants. The study started on 2017-02-27. Estimated completion is 2019-11-05.

What conditions does trial NCT02728752 study?

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

What interventions are being tested in trial NCT02728752?

The interventions under investigation include: Placebo (OTHER), Octagam 10% (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02728752?

This trial is sponsored by Octapharma, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02728752 being conducted?

This trial has 20 study locations across California, Florida, Kansas, Michigan, Minnesota. 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