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COMPLETED 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)

NCT01392326 · View on ClinicalTrials.gov ↗

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

792 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01392326

The ClinicalTrials.gov registry entry for NCT01392326 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 606 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 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 Psoriatic Arthritis appearing as the primary indexed condition, and to 3 interventions — of which Placebo Comparator 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: NCT01392326 reports 20 study locations spanning 17 distinct geographic areas — top geographies include Arizona, South Carolina, 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01392326?

The interventions under investigation include: Placebo Comparator (DRUG), Secukinumab (75 mg) (DRUG), Secukinumab (150 mg) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01392326?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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