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
NCT ID: NCT01377012
Last Updated: 2017-03-29
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
637 participants
INTERVENTIONAL
2011-08-30
2015-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
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)
NCT01350804
Secukinumab Efficacy and Safety Study in Patients With Rheumatoid Arthritis and Inadequate Response to Anti-TNFα Agents.
NCT01770379
A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients
NCT01426789
Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate
NCT01359943
Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)
NCT00928512
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
AIN457 10mg/kg-75mg
Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
Secukinumab (AIN457)
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
AIN457 10mg/kg-150mg
Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
Secukinumab (AIN457)
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
Placebo
Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (\>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
Placebo
Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Secukinumab (AIN457)
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
Placebo
Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Presence of RA classified by American College of Rheumatology (ACR) 2010 revised criteria for at least 3 months before screening
* At Baseline: Disease activity criteria defined by ≥ 6 tender joints out of 68 and ≥6 swollen joints out of 66 with at least 1 of the following at screening:
* Anti-Cyclic Citrullinated Peptide (CCP) antibodies positive OR
Rheumatoid Factor positive and with at least 1 of the following at screening:
* High sensitivity C-reactive protein (hsCRP) ≥ 10 mg/L OR Erythrocyte sedimentation rate (ESR) ≥ 28 mm/1st hr
* Patients must have been taking at least one anti-TNF-α agent given at an approved dose for at least 3 months before randomization and have experienced an inadequate response to treatment or have been intolerant to at least one administration of an anti-TNF-α agent
* Patients must be taking MTX for at least 3 months before randomization and have to be on a stable dose at least 4 weeks before randomization (7.5 to 25 mg/week For Japan only: 6 to 25 mg/week)
Exclusion Criteria
* Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
* Previous treatment with any cell-depleting therapies including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Novartis Investigative Site
Mesa, Arizona, United States
Novartis Investigative Site
Paradise Valley, Arizona, United States
Novartis Investigative Site
Peoria, Arizona, United States
Novartis Investigative Site
Little Rock, Arkansas, United States
Novartis Investigative Site
Santa Monica, California, United States
Novartis Investigative Site
Stanford, California, United States
Novartis Investigative Site
Torrance, California, United States
Novartis Investigative Site
Upland, California, United States
Novartis Investigative Site
Hialeah, Florida, United States
Novartis Investigative Site
Largo, Florida, United States
Novartis Investigative Site
Miami, Florida, United States
Novartis Investigative Site
Orlando, Florida, United States
Novartis Investigative Site
Palm Harbor, Florida, United States
Novartis Investigative Site
South Miami, Florida, United States
Novartis Investigative Site
Tamarac, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Tampa, Florida, United States
Novartis Investigative Site
Canton, Georgia, United States
Novartis Investigative Site
Bowling Green, Kentucky, United States
Novartis Investigative Site
Wheaton, Maryland, United States
Novartis Investigative Site
Eagan, Minnesota, United States
Novartis Investigative Site
Kansas City, Missouri, United States
Novartis Investigative Site
Las Vegas, Nevada, United States
Novartis Investigative Site
Asheville, North Carolina, United States
Novartis Investigative Site
Charlotte, North Carolina, United States
Novartis Investigative Site
Durham, North Carolina, United States
Novartis Investigative Site
Gallipolis, Ohio, United States
Novartis Investigative Site
Portland, Oregon, United States
Novartis Investigative Site
Pittsburgh, Pennsylvania, United States
Novartis Investigative Site
Columbia, South Carolina, United States
Novartis Investigative Site
Greenville, South Carolina, United States
Novartis Investigative Site
Jackson, Tennessee, United States
Novartis Investigative Site
Johnson City, Tennessee, United States
Novartis Investigative Site
Nashville, Tennessee, United States
Novartis Investigative Site
Dallas, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Houston, Texas, United States
Novartis Investigative Site
Mesquite, Texas, United States
Novartis Investigative Site
Salt Lake City, Utah, United States
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Buenos Aires, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires, Argentina
Novartis Investigative Site
Lanús, Buenos Aires, Argentina
Novartis Investigative Site
Caba, Buenos Aires F.D., Argentina
Novartis Investigative Site
Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, Argentina
Novartis Investigative Site
Córdoba, Córdoba Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
Rosario, Santa Fe Province, Argentina
Novartis Investigative Site
San Miguel de Tucumán, Tucumán Province, Argentina
Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Genk, , Belgium
Novartis Investigative Site
Ghent, , Belgium
Novartis Investigative Site
Winnipeg, Manitoba, Canada
Novartis Investigative Site
St. Catharines, Ontario, Canada
Novartis Investigative Site
Sainte-Foy, Quebec, Canada
Novartis Investigative Site
Bucaramanga, Colombia, Colombia
Novartis Investigative Site
Bogotá, , Colombia
Novartis Investigative Site
Medellín, , Colombia
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, Guatemala
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Budapest, , Hungary
Novartis Investigative Site
Eger, , Hungary
Novartis Investigative Site
Gyula, , Hungary
Novartis Investigative Site
Székesfehérvár, , Hungary
Novartis Investigative Site
Szolnok, , Hungary
Novartis Investigative Site
Veszprém, , Hungary
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Bangalore, Karnataka, India
Novartis Investigative Site
Amravati, Maharashtra, India
Novartis Investigative Site
Mumbai, Maharashtra, India
Novartis Investigative Site
Pune, Maharashtra, India
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India
Novartis Investigative Site
Ajmer, Rajasthan, India
Novartis Investigative Site
Jaipur, Rajasthan, India
Novartis Investigative Site
Secunderabad, Telangana, India
Novartis Investigative Site
Catania, CT, Italy
Novartis Investigative Site
Florence, FI, Italy
Novartis Investigative Site
Pieve di Coriano, MN, Italy
Novartis Investigative Site
Siena, SI, Italy
Novartis Investigative Site
Verona, VR, Italy
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Nagoya, Aichi-ken, Japan
Novartis Investigative Site
Chiba, Chiba, Japan
Novartis Investigative Site
Yotsukaidō, Chiba, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, Japan
Novartis Investigative Site
Iizuka, Fukuoka, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, Japan
Novartis Investigative Site
Takasaki, Gunma, Japan
Novartis Investigative Site
Hiroshima, Hiroshima, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Sapporo, Hokkaido, Japan
Novartis Investigative Site
Kamakura, Kanagawa, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, Japan
Novartis Investigative Site
Sagamihara, Kanagawa, Japan
Novartis Investigative Site
Yokohama, Kanagawa, Japan
Novartis Investigative Site
Kumamoto, Kumamoto, Japan
Novartis Investigative Site
Taihaku-ku, Miyagi, Japan
Novartis Investigative Site
Nagano, Nagano, Japan
Novartis Investigative Site
Nagasaki, Nagasaki, Japan
Novartis Investigative Site
Sasebo, Nagasaki, Japan
Novartis Investigative Site
Kurashiki, Okayama-ken, Japan
Novartis Investigative Site
Okayama, Okayama-ken, Japan
Novartis Investigative Site
Tsukubo-gun, Okayama-ken, Japan
Novartis Investigative Site
Hannan, Osaka, Japan
Novartis Investigative Site
Kawachi-Nagano, Osaka, Japan
Novartis Investigative Site
Osaka, Osaka, Japan
Novartis Investigative Site
Kawagoe, Saitama, Japan
Novartis Investigative Site
Tokorozawa, Saitama, Japan
Novartis Investigative Site
Fuji, Shizuoka, Japan
Novartis Investigative Site
Hamamatsu, Shizuoka, Japan
Novartis Investigative Site
Fuchū, Tokyo, Japan
Novartis Investigative Site
Itabashi-ku, Tokyo, Japan
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Shinjuku-ku, Tokyo, Japan
Novartis Investigative Site
Takaoka, Toyama, Japan
Novartis Investigative Site
Toyama, Toyama, Japan
Novartis Investigative Site
Shimonoseki, Yamaguchi, Japan
Novartis Investigative Site
Mexicali, Estado de Baja California, Mexico
Novartis Investigative Site
Mexicali, Estado de Baja California, Mexico
Novartis Investigative Site
Guadalajara, Jalisco, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Mexico City, Mexico City, Mexico
Novartis Investigative Site
Culiacán, Sinaloa, Mexico
Novartis Investigative Site
Panama City, Provincia de Panamá, Panama
Novartis Investigative Site
Panama City, Provincia de Panamá, Panama
Novartis Investigative Site
Ponce, , Puerto Rico
Novartis Investigative Site
San Juan, , Puerto Rico
Novartis Investigative Site
Bangkok, Bangkok, Thailand
Novartis Investigative Site
Bangkok, THA, Thailand
Novartis Investigative Site
Khon Kaen, THA, Thailand
Novartis Investigative Site
Bangkok, , Thailand
Novartis Investigative Site
Chiang Mai, , Thailand
Novartis Investigative Site
Songkhla, , Thailand
Novartis Investigative Site
Ankara, Turkey, Turkey (Türkiye)
Novartis Investigative Site
Leytonstone, London, United Kingdom
Novartis Investigative Site
Cannock, Staffordshire, United Kingdom
Novartis Investigative Site
Salisbury, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Huang Y, Fan Y, Liu Y, Xie W, Zhang Z. Efficacy and safety of secukinumab in active rheumatoid arthritis with an inadequate response to tumor necrosis factor inhibitors: a meta-analysis of phase III randomized controlled trials. Clin Rheumatol. 2019 Oct;38(10):2765-2776. doi: 10.1007/s10067-019-04595-1. Epub 2019 May 14.
Tahir H, Deodhar A, Genovese M, Takeuchi T, Aelion J, Van den Bosch F, Haemmerle S, Richards HB. Secukinumab in Active Rheumatoid Arthritis after Anti-TNFalpha Therapy: A Randomized, Double-Blind Placebo-Controlled Phase 3 Study. Rheumatol Ther. 2017 Dec;4(2):475-488. doi: 10.1007/s40744-017-0086-y. Epub 2017 Nov 14.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-000275-13
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CAIN457F2302/E1
Identifier Type: -
Identifier Source: org_study_id
NCT01901900
Identifier Type: -
Identifier Source: nct_alias
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.