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

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. 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.

Key facts

Study ID

NCT01377012

Run by

Novartis Pharmaceuticals

People needed

637

Starts

2011-08-30

Expected to finish

2015-09-09

Last updated by the study team

2017-03-29

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 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)

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 including but not limited to anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19)
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• 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 — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.