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.
AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Lanús, Buenos Aires, Argentina
Caba, Buenos Aires F.D., Argentina
Ciudad Autonoma de Bs As, Ciudad Autonoma de Bs As, Argentina
Córdoba, Córdoba Province, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
San Miguel de Tucumán, Tucumán Province, Argentina