Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Status:	Completed
Conditions:	Arthritis, Rheumatoid Arthritis
Therapuetic Areas:	Rheumatology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2009
End Date:	March 2011

A 16-week Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Dose-finding Study to Evaluate the Efficacy, Safety and Tolerability of Subcutaneous Secukinumab (AIN457) Followed by an Extension Phase up to a Total of 60 Weeks in Patients With Active Rheumatoid Arthritis Despite Stable Treatment With Methotrexate

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in
patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48
with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457
treatment in combination with MTX in RA.

Inclusion Criteria:

- Presence of RA classified by ACR 1987 revised criteria. Patients with active RA
should have been on MTX for at least 3 months and must currently be treated with a
stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks

- At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints
and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10
mg/L OR ESR > or = 28 mm/1st hr

Exclusion Criteria:

- RA patients functional status class IV classified according to the ACR 1991 revised
criteria

- Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or
morphine)

- Any therapy by intra-articular injections (e.g. corticosteroid) required for
treatment of acute RA flare within 4 weeks before randomization

Other protocol-defined inclusion/exclusion criteria may apply

We found this trial at

sites

Novartis Investigative Site

Peoria, Arizona 85381

from

Peoria, AZ