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NCT01392326 · ClinicalTrials.gov registry record · Phase 3

Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)

A Phase 3 study of Psoriatic Arthritis, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
606
Enrollment target
20
Study locations

NCT01392326 is a Phase 3 study of Psoriatic Arthritis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 606 participants, below the 840-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (28% lower). The trial reports 20 study locations across 17 states.

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The verdict

NCT01392326, a Phase 3 study of Psoriatic Arthritis, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
606 participants
Enrollment target
20
Study locations

Study Summary

This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Conditions Studied

Interventions

  • DRUG Placebo Comparator
  • DRUG Secukinumab (75 mg)
  • DRUG Secukinumab (150 mg)

Study Locations (20)

Arizona

  • Novartis Investigative Site - Mesa
  • Novartis Investigative Site - Paradise Valley

South Carolina

  • Novartis Investigative Site - Columbia
  • Novartis Investigative Site - North Charleston

Texas

  • Novartis Investigative Site - Benbrook
  • Novartis Investigative Site - Dallas

Alabama

  • Novartis Investigative Site - Anniston

California

  • Novartis Investigative Site - Upland

Florida

  • Novartis Investigative Site - Tamarac

Georgia

  • Novartis Investigative Site - Newnan

Massachusetts

  • Novartis Investigative Site - Boston

Trial Details

FieldValue
Enrollment Target 606 participants
Start Date 2011-09
Est. Completion 2014-10
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01392326

The ClinicalTrials.gov registry entry for NCT01392326 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 606 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 840-participant average among 48 other Psoriatic Arthritis trials with a reported enrollment target (28% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Psoriatic Arthritis appearing as the primary indexed condition, and to 3 interventions - of which Placebo Comparator is the first listed.

NCT01392326 reports 20 study locations spanning 17 distinct geographic areas - top geographies include Arizona, South Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT01392326 about?

NCT01392326 is a clinical study titled "Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)". This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

What is the current status of trial NCT01392326?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 606 participants. The study started on 2011-09. Estimated completion is 2014-10.

What conditions does trial NCT01392326 study?

This clinical trial studies the following conditions: Psoriatic Arthritis.

What interventions are being tested in trial NCT01392326?

The interventions under investigation include: Placebo Comparator (DRUG), Secukinumab (75 mg) (DRUG), Secukinumab (150 mg) (DRUG).

Who is sponsoring clinical trial NCT01392326?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01392326 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.