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



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/2/2013
Start Date:August 2011
Contact:Novartis Pharmaceuticals
Phone:862-778-8300

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A Randomized, Double-blind, Placebo-controlled Study of Efficacy, Safety and Tolerability of Secukinumab at 12 Weeks Administered With an i.v. or s.c. Loading Regimen Compared to Placebo in Patients With Active Rheumatoid Arthritis Despite Treatment With Methotrexate


The study will compare the efficacy and assess 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.


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.
We found this trial at
7
sites
Knoxville, Tennessee 37934
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Birmingham, Alabama 35294
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Los Angeles, California 90095
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Louisville, Kentucky 40202
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Omaha, Nebraska 68144
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Phoenix, Arizona 85012
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Tupelo, Mississippi 38801
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Tupelo, MS
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