Efficacy at 24 Weeks and Safety, Tolerability and Long Term Efficacy of Secukinumab (AIN457) in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Anti-Tumor Necrosis Factor α (Anti-TNFα) Agents (CAIN457F2309 and CAIN457F2309E1)
Public ClinicalTrials.gov record NCT01350804. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Double-blind, Placebo- and Active-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 1 Year in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2309) and A Four Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2309E1)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 or abatacept (active comparator). The core study was completed. However, the extension study was prematurely terminated after the primary endpoint analysis of the core study at week 24 had demonstrated numerically higher efficacy for the active comparator abatacept compared to secukinumab.
Study identification
- NCT ID
- NCT01350804
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 551 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 2011 (Type not available)
- Primary completion
- Feb 2015 (Actual)
- Completion
- Feb 2015 (Actual)
- Last update posted
- May 23, 2016
2011 – 2015
United States locations
- U.S. sites
- 44
- U.S. states
- 19
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Anniston | Alabama | 36207-5710 | — |
| Novartis Investigative Site | Vestavia Hills | Alabama | 35216 | — |
| Novartis Investigative Site | Freemont | California | 94538 | — |
| Novartis Investigative Site | Pomona | California | 91767 | — |
| Novartis Investigative Site | Upland | California | 91786 | — |
| Novartis Investigative Site | Van Nuys | California | 91405 | — |
| Novartis Investigative Site | Bridgeport | Connecticut | 06606 | — |
| Novartis Investigative Site | Aventura | Florida | 33180 | — |
| Novartis Investigative Site | Boca Raton | Florida | 33486 | — |
| Novartis Investigative Site | Hialeah | Florida | 33012 | — |
| Novartis Investigative Site | Miami | Florida | 33126 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | Palm Harbor | Florida | 34684 | — |
| Novartis Investigative Site | Pembroke Pines | Florida | 33026 | — |
| Novartis Investigative Site | Pensacola | Florida | 32514 | — |
| Novartis Investigative Site | Plantation | Florida | 33324 | — |
| Novartis Investigative Site | Sarasota | Florida | 34239 | — |
| Novartis Investigative Site | Tampa | Florida | 33603 | — |
| Novartis Investigative Site | Coeur d'Alene | Idaho | 83814 | — |
| Novartis Investigative Site | Morton Grove | Illinois | 60053 | — |
| Novartis Investigative Site | Springfield | Illinois | 62704 | — |
| Novartis Investigative Site | Wichita | Kansas | 67214 | — |
| Novartis Investigative Site | Bowling Green | Kentucky | 42101 | — |
| Novartis Investigative Site | Lexington | Kentucky | 40615 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02111 | — |
| Novartis Investigative Site | Lansing | Michigan | 48910 | — |
| Novartis Investigative Site | Eagan | Minnesota | 55121 | — |
| Novartis Investigative Site | Kansas City | Missouri | 66160-7330 | — |
| Novartis Investigative Site | Richmond Heights | Missouri | 63117 | — |
| Novartis Investigative Site | Omaha | Nebraska | 68114 | — |
| Novartis Investigative Site | Cincinnati | Ohio | 45219 | — |
| Novartis Investigative Site | Zanesville | Ohio | 43701 | — |
| Novartis Investigative Site | Oklahoma City | Oklahoma | 73103 | — |
| Novartis Investigative Site | Jackson | Tennessee | 38305 | — |
| Novartis Investigative Site | Kingsport | Tennessee | 37660 | — |
| Novartis Investigative Site | Austin | Texas | 78731 | — |
| Novartis Investigative Site | Carrollton | Texas | 75010 | — |
| Novartis Investigative Site | Dallas | Texas | 75204 | — |
| Novartis Investigative Site | Dallas | Texas | 75216 | — |
| Novartis Investigative Site | Houston | Texas | 77034 | — |
| Novartis Investigative Site | Sugar Land | Texas | 77479 | — |
| Novartis Investigative Site | Waco | Texas | 76710 | — |
| Novartis Investigative Site | Spokane | Washington | 99204 | — |
| Novartis Investigative Site | Clarksburg | West Virginia | 26301 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 73 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01350804, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 23, 2016 · Synced Oct 31, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01350804 live on ClinicalTrials.gov.