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

Inclusion criteria:

- 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

Exclusion criteria:

- 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.