Who is sponsoring NCT03155347?

NCT03155347 is sponsored by Hoffmann-La Roche.

What condition does NCT03155347 study?

NCT03155347 studies Rheumatoid Arthritis.

What drugs are being tested in NCT03155347?

Interventions: Tocilizumab, MTX, Placebo Matched to MTX, Placebo Matched to Tocilizumab.

What is the status of NCT03155347?

NCT03155347 is currently COMPLETED.

Last reviewed 2023-11-28 · How we verify

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

NCT03155347 PHASE3 COMPLETED

This is a randomized, double-blind, multi-center, parallel-group study to evaluate the efficacy and safety of subcutaneous (SC) tocilizumab (162 milligrams \[mg\] every 2 weeks \[Q2W\]) given as monotherapy and in combination with MTX versus MTX given as monotherapy, in participants with moderate to severe active rheumatoid arthritis (RA) who have inadequate response to current DMARD therapy. The study comprises a 24-week double-blind treatment phase, followed by a 24-week extension phase.

Details

Lead sponsor	Hoffmann-La Roche
Phase	PHASE3
Status	COMPLETED
Enrolment	340
Start date	Wed Aug 02 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Mon Aug 08 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Rheumatoid Arthritis

Interventions

Tocilizumab
MTX
Placebo Matched to MTX
Placebo Matched to Tocilizumab

Countries

China