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

Novartis

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: Secukinumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01426789

CAIN457F2208

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Secukinumab

Experimental group

Description:

10 mg/kg intravenous (I.V.)

Treatment:

Drug: Secukinumab

Placebo

Placebo Comparator group

Description:

Placebo I.V.

Treatment:

Drug: Placebo