A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA)

PHASE3CompletedINTERVENTIONAL
Enrollment

91

Participants

Timeline

Start Date

February 28, 2015

Primary Completion Date

November 30, 2016

Study Completion Date

November 30, 2016

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Sarilumab

Pharmaceutical form:solution

DRUG

Sulfasalazine

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Leflunomide

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Bucillamine

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

Tacrolimus

Pharmaceutical form: Capsule Route of administration: Oral

DRUG

Mizoribine

Pharmaceutical form: Tablet Route of administration: Oral

Trial Locations (40)

Unknown

Investigational Site Number 392010, Asahi-Shi

Investigational Site Number 392001, Asahikawa-Shi

Investigational Site Number 392070, Beppu-Shi

Investigational Site Number 392036, Chiba

Investigational Site Number 392083, Chūōku

Investigational Site Number 392004, Fukui-shi

Investigational Site Number 392039, Fukuoka

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 392050, Kato-Shi

Investigational Site Number 392037, Kawachi-Nagano-Shi

Investigational Site Number 392099, Kawasaki-Shi

Investigational Site Number 392013, Kitakyushu-Shi

Investigational Site Number 392097, Kochi

Investigational Site Number 392065, Kushiro

Investigational Site Number 392026, Matsuyama

Investigational Site Number 392034, Miyagi-Gun

Investigational Site Number 392076, Nagoya

Investigational Site Number 392080, Nagoya

Investigational Site Number 392046, Narashino-Shi

Investigational Site Number 392062, Okayama

Investigational Site Number 392027, Osaki-Shi

Investigational Site Number 392059, Ōita

Investigational Site Number 392049, Sagamihara-Shi

Investigational Site Number 392014, Sapporo

Investigational Site Number 392041, 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 392029, Shizuoka

Investigational Site Number 392023, Takaoka-Shi

Investigational Site Number 392003, Tomakomai-Shi

Investigational Site Number 392074, Urasoe-Shi

Investigational Site Number 392079, Urayasu-Shi

Investigational Site Number 392048, Yokohama

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Regeneron Pharmaceuticals

INDUSTRY

lead

Sanofi

INDUSTRY