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

COMPLETED Phase 3

Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease

NCT03357471 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to evaluate the post-use structural integrity of used devices and cassettes via visual examination.

Interventions

  • DRUG e-Device

Study Locations (20)

Texas

  • Ra0098 111 — Austin
  • Ra0098 123 — Austin
  • Ra0098 102 — Austin
  • Ra0098 128 — Corpus Christi
  • Ra0098 106 — Nassau Bay

Arizona

  • Ra0098 116 — Mesa
  • Ra0098 107 — Mesa
  • Ra0098 135 — Phoenix
  • Ra0098 119 — Tucson

Florida

  • Ra0098 131 — Clermont
  • Ra0098 132 — Coral Springs

Missouri

  • Ra0098 105 — St Louis
  • Ra0098 104 — St Louis

California

  • Ra0098 101 — Covina

Georgia

  • Ra0098 127 — Gainesville

Iowa

  • Ra0098 122 — Clive

New Jersey

  • Ra0098 103 — Dover

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2017-11-03
Est. Completion 2018-07-02
Phase Phase 3

Sponsor

UCB Biopharma S.P.R.L.

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03357471

The ClinicalTrials.gov registry entry for NCT03357471 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 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is UCB Biopharma S.P.R.L., which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Active Psoriatic Arthritis appearing as the primary indexed condition, and to 1 intervention — of which e-Device 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: NCT03357471 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Texas, Arizona, Florida. 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 NCT03357471 about?

NCT03357471 is a clinical study titled "Study to Test the Safe and Effective Use of an e-Device for the Self-injection of Certolizumab Pegol Solution by Subjects With Moderate to Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis, Active Psoriatic Arthritis, or Moderately to Severely Active Crohn's Disease". The purpose of the study is to evaluate the ability of subjects who are already prescribed Certolizumab Pergol therapy and have been self injecting with prefilled syringes for at least the previous three months, to safely and effectively self-inject Certolizumab Pegol (CZP) using the e-Device and to...

What is the current status of trial NCT03357471?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 70 participants. The study started on 2017-11-03. Estimated completion is 2018-07-02.

What conditions does trial NCT03357471 study?

This clinical trial studies the following conditions: Active Psoriatic Arthritis, Moderately to Severely Active Crohn's Disease, Moderate and Severe Active Rheumatoid Arthritis, Active Ankylosing Spondylitis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03357471?

The interventions under investigation include: e-Device (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03357471?

This trial is sponsored by UCB Biopharma S.P.R.L., which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03357471 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Iowa. 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