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
Public ClinicalTrials.gov record NCT01377012. 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-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)
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. 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.
Study identification
- NCT ID
- NCT01377012
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 637 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
- Aug 30, 2011 (Actual)
- Primary completion
- Sep 9, 2015 (Actual)
- Completion
- Sep 9, 2015 (Actual)
- Last update posted
- Mar 29, 2017
2011 – 2015
United States locations
- U.S. sites
- 39
- U.S. states
- 18
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Mesa | Arizona | 85202 | — |
| Novartis Investigative Site | Paradise Valley | Arizona | 85253 | — |
| Novartis Investigative Site | Peoria | Arizona | 85381 | — |
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | — |
| Novartis Investigative Site | Santa Monica | California | 90404 | — |
| Novartis Investigative Site | Stanford | California | 94305 | — |
| Novartis Investigative Site | Torrance | California | 90502 | — |
| Novartis Investigative Site | Upland | California | 91786 | — |
| Novartis Investigative Site | Hialeah | Florida | 33016 | — |
| Novartis Investigative Site | Largo | Florida | 33773 | — |
| Novartis Investigative Site | Miami | Florida | 33169 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | Palm Harbor | Florida | 34684 | — |
| Novartis Investigative Site | South Miami | Florida | 33143 | — |
| Novartis Investigative Site | Tamarac | Florida | 33321 | — |
| Novartis Investigative Site | Tampa | Florida | 33612 | — |
| Novartis Investigative Site | Tampa | Florida | 33614-7118 | — |
| Novartis Investigative Site | Canton | Georgia | 30114 | — |
| Novartis Investigative Site | Bowling Green | Kentucky | 42101 | — |
| Novartis Investigative Site | Wheaton | Maryland | 20902 | — |
| Novartis Investigative Site | Eagan | Minnesota | 55121 | — |
| Novartis Investigative Site | Kansas City | Missouri | 66160-7330 | — |
| Novartis Investigative Site | Las Vegas | Nevada | 89119 | — |
| Novartis Investigative Site | Asheville | North Carolina | 28801 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28210 | — |
| Novartis Investigative Site | Durham | North Carolina | 27704 | — |
| Novartis Investigative Site | Gallipolis | Ohio | 45631 | — |
| Novartis Investigative Site | Portland | Oregon | 97239 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15237 | — |
| Novartis Investigative Site | Columbia | South Carolina | 29204 | — |
| Novartis Investigative Site | Greenville | South Carolina | 29601 | — |
| Novartis Investigative Site | Jackson | Tennessee | 38305 | — |
| Novartis Investigative Site | Johnson City | Tennessee | 37604 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37205 | — |
| Novartis Investigative Site | Dallas | Texas | 75390 | — |
| Novartis Investigative Site | Houston | Texas | 77034 | — |
| Novartis Investigative Site | Houston | Texas | 77074 | — |
| Novartis Investigative Site | Mesquite | Texas | 75150 | — |
| Novartis Investigative Site | Salt Lake City | Utah | 84132 | — |
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 103 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01377012, 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 Mar 29, 2017 · Synced Oct 21, 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 NCT01377012 live on ClinicalTrials.gov.