Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking Methotrexate

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

The study compared the efficacy and assessed the safety of secukinumab given as 3 intravenous (i.v.) loading doses or weekly sub-cutaneous (s.c.) loading doses, compared to placebo, followed by monthly s.c. injections in patients with active Rheumatoid Arthritis (RA) despite treatment with Methotrexate.

Key facts

Study ID

NCT01359943

Run by

Novartis Pharmaceuticals

People needed

221

Starts

2011-10-01

Expected to finish

2013-12-01

Last updated by the study team

2015-03-02

Who can join

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

You may qualify if…

• presence of RA classified by ACR 2010 revised criteria for at least 3 months before screening
• must have been taking MTX for at least 3 months before randomization and must currently be on a stable dose of MTX for at least 4 weeks before randomization.
• At Baseline: Disease activity criteria defined by >6 tender joints out of 68 and >6 swollen joints out of 66 and with at least 1 of the following at screening: Anti-CCP antibodies positive OR Rheumatoid Factor positive and with at least 1 of the following at screening: hsCRP ≥ 10 mg/L OR ESR ≥ 28

You may not qualify if…

• RA patients functional status class IV according to the ACR 1991 revised criteria
• Previous exposure to secukinumab or any other biologic drug directly targeting IL-17 or IL-17 receptor
• Previous exposure ever to an anti-TNF-a agent or any other immunomodulatory biologic agent (experimental or approved)
• Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
• Any therapy by intra-articular injections (e.g. corticosteroid, hyaluronan) required for treatment of arthritis within 4 weeks before randomization
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Vestavia Hills, Alabama, United States
• Novartis Investigative Site — Peoria, Arizona, United States
• Novartis Investigative Site — Upland, California, United States
• Novartis Investigative Site — Bowling Green, Kentucky, United States
• Novartis Investigative Site — Tupelo, Mississippi, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Nashville, Tennessee, United States
• Novartis Investigative Site — Pleven, Bulgaria, Bulgaria
• Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
• Novartis Investigative Site — Plovdiv, Bulgaria, Bulgaria
• Novartis Investigative Site — Sevlievo, Bulgaria, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria, Bulgaria
• Novartis Investigative Site — Sofia, Bulgaria, Bulgaria
• Novartis Investigative Site — St. John's, Newfoundland and Labrador, Canada
• Novartis Investigative Site — Sainte-Foy, Quebec, Canada
• Novartis Investigative Site — Szeged, Hungary, Hungary
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Debrecen, Hungary
• Novartis Investigative Site — Valeggio sul Mincio, (vr), Italy
• Novartis Investigative Site — Arenzano, GE, Italy
• Novartis Investigative Site — Genova, GE, Italy
• Novartis Investigative Site — Roma, RM, Italy
• Novartis Investigative Site — Siena, SI, Italy

Full record on ClinicalTrials.gov

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