View Clinical Trial (Medical Research Study)

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

---

Conditions:		Rheumatoid Arthritis
Purpose:		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.
Study Summary:
Criteria:		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.
NCT ID:		NCT01359943
Primary Contact:		Study Director Novartis Pharmceuticals Novartis Pharmaceuticals Novartis Pharmaceuticals Phone: 862-778-8300
Backup Contact:		N/A
Location Contact:		Vestavia, Alabama 35216 United States Novartis Pharmaceuticals Phone: 862-778-8300 Site Status: Not yet recruiting

---

---