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

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The study compared the efficacy and assessed 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Methotrexate

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.