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COMPLETED Phase 3

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

NCT01356602 · View on ClinicalTrials.gov ↗

Study Summary

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Triamcinolone Acetonide
  • DRUG Canakinumab pre-filled syringe
  • DRUG Canakinumab lyophilized powder

Study Locations (20)

California

  • Novartis Investigative Site — Buena Park
  • Novartis Investigative Site — Fair Oaks
  • Novartis Investigative Site — Norwalk
  • Novartis Investigative Site — Orangevale
  • Novartis Investigative Site — Pasadena
  • Novartis Investigative Site — Westlake Village

Florida

  • Novartis Investigative Site — Clearwater
  • Novartis Investigative Site — Jupiter
  • Novartis Investigative Site — Largo
  • Novartis Investigative Site — South Miami

Alabama

  • Novartis Investigative Site — Anniston
  • Novartis Investigative Site — Gulf Shores
  • Novartis Investigative Site — Mobile

Arizona

  • Novartis Investigative Site — Chandler
  • Novartis Investigative Site — Phoenix
  • Novartis Investigative Site — Scottsdale

Georgia

  • Novartis Investigative Site — Augusta
  • Novartis Investigative Site — Decatur

Idaho

  • Novartis Investigative Site — Meridian

Kansas

  • Novartis Investigative Site — Overland Park

Trial Details

FieldValue
Enrollment Target 397 participants
Start Date 2011-05
Est. Completion 2012-09
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 NCT01356602

The ClinicalTrials.gov registry entry for NCT01356602 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 397 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 Acute Gouty Arthritis appearing as the primary indexed condition, and to 4 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: NCT01356602 reports 20 study locations spanning 7 distinct geographic areas — top geographies include California, Florida, Alabama. 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 NCT01356602 about?

NCT01356602 is a clinical study titled "Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients". This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

What is the current status of trial NCT01356602?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2011-05. Estimated completion is 2012-09.

What conditions does trial NCT01356602 study?

This clinical trial studies the following conditions: Acute Gouty 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 NCT01356602?

The interventions under investigation include: Placebo (DRUG), Triamcinolone Acetonide (DRUG), Canakinumab pre-filled syringe (DRUG), Canakinumab lyophilized powder (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01356602?

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 NCT01356602 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