An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy

PHASE3CompletedINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

August 2, 2017

Primary Completion Date

August 8, 2022

Study Completion Date

August 8, 2022

Conditions
Rheumatoid Arthritis
Interventions
DRUG

Tocilizumab

Participants will receive tocilizumab 162 mg given as 0.9 milliliter (mL) of a 180 mg/mL solution in a prefilled syringe, administered by SC injection Q2W.

DRUG

MTX

Participants will receive MTX stable doses at 10 to 25 mg orally.

DRUG

Placebo Matched to MTX

Placebo matched to MTX.

DRUG

Placebo Matched to Tocilizumab

Placebo matched to tocilizumab.

Trial Locations (20)

100029

China-Japan Friendship Hospital, Beijing

100034

Peking University First Hospital, Beijing

100044

Peking University People's Hospital, Beijing

100730

Beijing Union Hospital, Beijing

110004

Shengjing Hospital of China Medical University, Shenyang

130021

the First Hospital of Jilin University, Changchun

150001

The 1st Affiliated Hospital of Harbin Medical University, Harbin

210008

Jiangsu Province Hospital, Nanjing

230022

The First Affiliated Hospital of Anhui Medical University, Hefei

233004

Affiliated Hospital of Bengbu Medical College, Bengbu

250012

Qilu Hospital of Shandong University, Jinan

300052

Tianjin Medical University General Hospital, Tianjin

314001

The First Hospital of Jiaxing, Jiaxing

337000

Pingxiang People Hospital, Pingxiang

510080

Guangdong General Hospital, Guangzhou

610041

West China Hospital, Sichuan University, Chengdu

650032

The First Affilliated Hospital of Kunming Medical College, Kunming

014010

The First Affiliated Hospital of Baotou Medical College, Baotou

010050

Affiliated Hospital of Inner Mongolia Medical College, Hohhot

Unknown

The Second Hospital of Shanxi Medical University, Taiyuan

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT03155347 - An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) Therapy | Biotech Hunter | Biotech Hunter