A Biomarker Study of Secukinumab in Rheumatoid Arthritis (RA) Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study aims to confirm if patients with a specific biomarker might have a better response to secukinumab treatment. To meet this purpose, exploratory biomarker studies will be done. The goals of these exploratory studies are to (1) find biomarkers that will identify persons with rheumatoid arthritis who will have the best possible response to secukinumab and (2) to identify persons who will have fewer side effects in order to maximize their benefit from secukinumab.

Key facts

Study ID

NCT01426789

Run by

Novartis Pharmaceuticals

People needed

100

Starts

2011-08-01

Expected to finish

2014-02-01

Last updated by the study team

2015-08-10

Who can join

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

You may qualify if…

• Diagnosis of rheumatoid arthritis
• Patients must be either DMARD naive or have failed at least one DMARD agent (e.g. MTX, leflunamide or sulfasalazine)
• Patients are allowed up to 3 DMARDs at study entry (e.g. MTX, sulfasalazine or hydroxychloroquine) as long as their dose was stable for 4 weeks prior to initiating study treatment
• Disease activity at screening defined by ≥6 out of 28 tender joints and ≥6 out of 28 swollen joints and hsCRP >10mg/L

You may not qualify if…

• Patients with severe rheumatoid arthritis (functional status class IV according to the ACR 1991 revised criteria)
• Previous exposure to secukinumab or any other biologic, including TNF inhibitors.
• Use of high potency opioid analgesics
• Pregnant or nursing (lactating) women
• Use of any investigational drug other than RA therapy and/or devices at the time of randomization or within 30 days or 5 half-lives of randomization, whichever is longer.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Kortrijk, Belgium
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Frankfurt am Main, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Herne, Germany
• Novartis Investigative Site — Leipzig, Germany
• Novartis Investigative Site — Magdeburg, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Smolensk, Russia, Russia
• Novartis Investigative Site — Moscow, Russia
• Novartis Investigative Site — Nizhny Novgorod, Russia
• Novartis Investigative Site — Petrozavodsk, Russia
• Novartis Investigative Site — Saint Petersburg, Russia
• Novartis Investigative Site — Tver', Russia
• Novartis Investigative Site — Yaroslavl, Russia
• Novartis Investigative Site — Yaroslavl, Russia
• Novartis Investigative Site — Manchester, Manchester, United Kingdom
• Novartis Investigative Site — Belfast, United Kingdom
• Novartis Investigative Site — Phoenix, Arizona, United States
• Novartis Investigative Site — Tuscon, Arizona, United States
• Novartis Investigative Site — Anahiem, California, United States
• Novartis Investigative Site — Clearwater, Florida, United States
• Novartis Investigative Site — Coral Gables, Florida, United States

Full record on ClinicalTrials.gov

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