A Study Assessing the Efficacy and Safety of Sarilumab Added to MTX in Japanese Patients With Moderately to Severely Active Rheumatoid Arthritis (SARIL-RA-KAKEHASI)

PHASE3CompletedINTERVENTIONAL
Enrollment

243

Participants

Timeline

Start Date

November 30, 2014

Primary Completion Date

October 31, 2016

Study Completion Date

October 31, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Sarilumab SAR153191 (REGN88)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

OTHER

Placebo (for sarilumab)

Pharmaceutical form: solution for injection Route of administration: subcutaneous

DRUG

Methotrexate

Dispensed according to local practice.

DRUG

Folic acid

Dispensed according to local practice.

Trial Locations (96)

Unknown

Investigational Site Number 392010, Asahi-Shi

Investigational Site Number 392001, Asahikawa-Shi

Investigational Site Number 392035, Asahikawa-Shi

Investigational Site Number 392070, Beppu-Shi

Investigational Site Number 392036, Chiba

Investigational Site Number 392083, Chūōku

Investigational Site Number 392047, Fuchu-Shi

Investigational Site Number 392004, Fukui-shi

Investigational Site Number 392007, Fukuoka

Investigational Site Number 392038, Fukuoka

Investigational Site Number 392039, Fukuoka

Investigational Site Number 392078, Fukushima

Investigational Site Number 392054, Funabashi-Shi

Investigational Site Number 392015, Hachioji-Shi

Investigational Site Number 392085, Hannan-Shi

Investigational Site Number 392091, Hiroshima

Investigational Site Number 392098, Hiroshima

Investigational Site Number 392009, Hitachi-Naka

Investigational Site Number 392011, Hitachi-Naka

Investigational Site Number 392030, Ichinomiya-Shi

Investigational Site Number 392002, Iizuka-Shi

Investigational Site Number 392019, Kagoshima

Investigational Site Number 392066, Kamakura-Shi

Investigational Site Number 392086, Kamogawa-Shi

Investigational Site Number 392050, Kato-Shi

Investigational Site Number 392037, Kawachi-Nagano-Shi

Investigational Site Number 392093, Kawagoe-Shi

Investigational Site Number 392099, Kawasaki-Shi

Investigational Site Number 392016, Kirishima-Shi

Investigational Site Number 392013, Kitakyushu-Shi

Investigational Site Number 392024, Kitakyushu-Shi

Investigational Site Number 392045, Kitakyushu-Shi

Investigational Site Number 392063, Kiyose-Shi

Investigational Site Number 392051, Kobe

Investigational Site Number 392097, Kochi

Investigational Site Number 392040, Koushi-Shi

Investigational Site Number 392069, Kumamoto

Investigational Site Number 392089, Kurashiki-Shi

Investigational Site Number 392065, Kushiro

Investigational Site Number 392026, Matsuyama

Investigational Site Number 392081, Matsuyama

Investigational Site Number 392094, Matsuyama

Investigational Site Number 392042, Meguro-Ku

Investigational Site Number 392082, Meguro-Ku

Investigational Site Number 392012, Mito

Investigational Site Number 392034, Miyagi-Gun

Investigational Site Number 392053, Morioka

Investigational Site Number 392032, Nagano

Investigational Site Number 392064, Nagasaki

Investigational Site Number 392043, Nagoya

Investigational Site Number 392056, Nagoya

Investigational Site Number 392076, Nagoya

Investigational Site Number 392080, Nagoya

Investigational Site Number 392031, Nakano

Investigational Site Number 392046, Narashino-Shi

Investigational Site Number 392067, Narashino-Shi

Investigational Site Number 392044, Nishinomiya-Shi

Investigational Site Number 392062, Okayama

Investigational Site Number 392008, Omura-Shi

Investigational Site Number 392057, Osaka

Investigational Site Number 392060, Osaka

Investigational Site Number 392061, Osaka

Investigational Site Number 392096, Osaka

Investigational Site Number 392027, Osaki-Shi

Investigational Site Number 392059, Ōita

Investigational Site Number 392049, Sagamihara-Shi

Investigational Site Number 392072, Saitama-Shi

Investigational Site Number 392075, Sakaishi

Investigational Site Number 392014, Sapporo

Investigational Site Number 392068, Sapporo

Investigational Site Number 392073, Sapporo

Investigational Site Number 392006, Sasebo-Shi

Investigational Site Number 392021, Sendai

Investigational Site Number 392022, Sendai

Investigational Site Number 392033, Sendai

Investigational Site Number 392071, Sendai

Investigational Site Number 392100, Sendai

Investigational Site Number 392029, Shizuoka

Investigational Site Number 392025, Sumida-Ku

Investigational Site Number 392092, Sumida-Ku

Investigational Site Number 392023, Takaoka-Shi

Investigational Site Number 392095, Takarazuka-Shi

Investigational Site Number 392020, Takasaki-Shi

Investigational Site Number 392088, Takatsuki-Shi

Investigational Site Number 392018, Tokorozawa-Shi

Investigational Site Number 392003, Tomakomai-Shi

Investigational Site Number 392005, Tomakomai-Shi

Investigational Site Number 392077, Tonami-Shi

Investigational Site Number 392052, Toshima-Ku

Investigational Site Number 392058, Toyama

Investigational Site Number 392055, Toyonaka-Shi

Investigational Site Number 392074, Urasoe-Shi

Investigational Site Number 392079, Urayasu-Shi

Investigational Site Number 392048, Yokohama

Investigational Site Number 392090, Yokohama

Investigational Site Number 392101, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY