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COMPLETED Phase 3

Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents

NCT01377012 · View on ClinicalTrials.gov ↗

Study Summary

The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Secukinumab (AIN457)

Study Locations (20)

Florida

  • Novartis Investigative Site — Hialeah
  • Novartis Investigative Site — Largo
  • Novartis Investigative Site — Miami
  • Novartis Investigative Site — Orlando
  • Novartis Investigative Site — Palm Harbor
  • Novartis Investigative Site — South Miami
  • Novartis Investigative Site — Tamarac
  • Novartis Investigative Site — Tampa
  • Novartis Investigative Site — Tampa

California

  • Novartis Investigative Site — Santa Monica
  • Novartis Investigative Site — Stanford
  • Novartis Investigative Site — Torrance
  • Novartis Investigative Site — Upland

Arizona

  • Novartis Investigative Site — Mesa
  • Novartis Investigative Site — Paradise Valley
  • Novartis Investigative Site — Peoria

Arkansas

  • Novartis Investigative Site — Little Rock

Georgia

  • Novartis Investigative Site — Canton

Kentucky

  • Novartis Investigative Site — Bowling Green

Maryland

  • Novartis Investigative Site — Wheaton

Trial Details

FieldValue
Enrollment Target 637 participants
Start Date 2011-08-30
Est. Completion 2015-09-09
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 NCT01377012

The ClinicalTrials.gov registry entry for NCT01377012 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 637 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 Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 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: NCT01377012 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Arizona. 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 NCT01377012 about?

NCT01377012 is a clinical study titled "Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Anti-TNFα Agents". The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study ...

What is the current status of trial NCT01377012?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 637 participants. The study started on 2011-08-30. Estimated completion is 2015-09-09.

What conditions does trial NCT01377012 study?

This clinical trial studies the following conditions: Rheumatoid 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 NCT01377012?

The interventions under investigation include: Placebo (BIOLOGICAL), Secukinumab (AIN457) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01377012?

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 NCT01377012 being conducted?

This trial has 20 study locations across Arizona, Arkansas, 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