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)

Completed · Phase 3 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT01350804

Run by

Novartis Pharmaceuticals

People needed

551

Starts

2011-09-01

Expected to finish

2015-02-01

Last updated by the study team

2016-05-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or non-pregnant, non-lactating female patients
• Presence of RA classified by 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 (Anti-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 millimeter (mm)/1st hour
• 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 or any other DMARD (but not more than 1 DMARD) 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 MTX or other DMARD at maximum tolerated dose)

You may not qualify if…

• Chest x-ray with evidence of ongoing infectious or malignant process, obtained within 3 months prior to screening and evaluated by a qualified physician
• RA patients functional status class IV according to the ACR 1991 revised criteria
• Patients who have ever received biologic immunomodulating agents except for those targeting TNFα
• Previous treatment with any cell-depleting therapies
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Vestavia Hills, Alabama, United States
• Novartis Investigative Site — Freemont, California, United States
• Novartis Investigative Site — Pomona, California, United States
• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Van Nuys, California, United States
• Novartis Investigative Site — Bridgeport, Connecticut, United States
• Novartis Investigative Site — Aventura, Florida, United States
• Novartis Investigative Site — Boca Raton, Florida, United States
• Novartis Investigative Site — Hialeah, 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 — Pembroke Pines, Florida, United States
• Novartis Investigative Site — Pensacola, Florida, United States
• Novartis Investigative Site — Plantation, Florida, United States
• Novartis Investigative Site — Sarasota, Florida, United States
• Novartis Investigative Site — Tampa, Florida, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Morton Grove, Illinois, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Wichita, Kansas, United States
• Novartis Investigative Site — Bowling Green, Kentucky, United States
• Novartis Investigative Site — Lexington, Kentucky, United States
• Novartis Investigative Site — Boston, Massachusetts, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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