A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)
A Randomized, Double-blind, Placebo-controlled Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Safety, Tolerability and Long Term Efficacy up to 2 Years in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Anti-TNFα Agents (CAIN457F2302) and a Three Year Extension Study to Evaluate the Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Rheumatoid Arthritis (CAIN457F2302E1)
The core and extension studies assessed the safety and efficacy of secukinumab when added to a background therapy in patients with active rheumatoid arthritis who are intolerant to or have had an inadequate response to anti-TNF-α agents. Patients received either secukinumab, placebo. The core study was completed. However, the extension study was terminated early (unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
CAIN457F2302 (Core Study): Completed Sep 9 2015
CAIN457F2302E1 (Extension study): terminated early May 26 2015, ((unrelated to safety) due to the results of study AIN457F2309, which indicated the efficacy of AIN457 was not comparable to the currently available RA treatment, abatacept, thus leading to closing of the AIN457 RA program.
Inclusion criteria:
Rheumatoid Factor positive and with at least 1 of the following at screening:
Exclusion criteria:
Buenos Aires, Buenos Aires C1114AAP, Argentina
Buenos Aires, Buenos Aires C1417EYG, Argentina
Caba, Buenos Aires C1181ACH, Argentina
Caba, Buenos Aires F.D. C1419AHN, Argentina
Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As C1428AZF, Argentina
Hyderabad, Andhra Pradesh 500004, India
Taihaku-ku, Miyagi 982-0032, Japan
Tsukubo-gun, Okayama-ken 701-0304, Japan
Itabashi-ku, Tokyo 174-0071, Japan
Setagaya-ku, Tokyo 156-0052, Japan
Shinjuku-ku, Tokyo 160-0054, Japan
Shinjuku-ku, Tokyo 160-8582, Japan