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NCT01431638 · ClinicalTrials.gov registry record · Phase 3

Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

A Phase 3 study, sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 3
Development phase
397
Enrollment target

NCT01431638 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 397 participants.

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The verdict

NCT01431638, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 3
Development phase
397 participants
Enrollment target

Study Summary

This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Interventions

  • DRUG Canakinumab 150mg in prefilled syringe

Trial Details

FieldValue
Enrollment Target 397 participants
Start Date 2011-08-25
Est. Completion 2013-05-09
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

1,375 total trials

What the Registry Record Tells You About NCT01431638

The ClinicalTrials.gov registry entry for NCT01431638 describes a study currently listed as completed, categorized as Phase 3. 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 1,375 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Canakinumab 150mg in prefilled syringe is the first listed.

NCT01431638 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01431638 about?

NCT01431638 is a clinical study titled "Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients". This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

What is the current status of trial NCT01431638?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2011-08-25. Estimated completion is 2013-05-09.

What interventions are being tested in trial NCT01431638?

The interventions under investigation include: Canakinumab 150mg in prefilled syringe (DRUG).

Who is sponsoring clinical trial NCT01431638?

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

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

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.