Efficacy, Safety and Tolerability of Secukinumab in Patients With Rheumatoid Arthritis Taking 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.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- Efficacy as measured by the proportion of patients who achieve ACR20. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Efficacy as measured by the proportion of patients who achieve ACR 50 and ACR 70. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in Disease Activity Score (DAS) 28 response (using hsCRP or ESR) and EULAR response. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in ACR components, including markers of inflammation (hsCRP and ESR) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change in HAQ-DI score. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
- Safety and tolerability will be assessed by the absolute and relative frequency of patients with adverse events, clinically notable laboratory values, clinically notable vital signs abnormalities, injection site reactions and immunogenicity. [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
|Experimental: secukinumab 10 mg/kg i.v. and placebo s.c.||
secukinumab 10 mg/kg i.v. and placebo s.c.
|Experimental: secukinumab 150 mg s.c. and placebo i.v.||
150 mg s.c. and placebo i.v.
|Placebo Comparator: placebo i.v. and s.c||
placebo i.v. and s.c
|Contact: Novartis Pharmaceuticals||862-778-8300|
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|Study Director:||Novartis Pharmceuticals||Novartis Pharmaceuticals|