Tocilizumab
DrugParticipants 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.
Other names: RO4877533
NCT Number: NCT03155347
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.
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Notify Me18 year–70 year
All sexes
Interventional
Phase 3
The First Affiliated Hospital of Baotou Medical College, Baotou, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: RO4877533
Participants will receive MTX stable doses at 10 to 25 mg orally.
Placebo matched to MTX.
Placebo matched to tocilizumab.
Time frame: Week 24
Time frame: Week 24
Time frame: Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: Baseline, Week 24
Time frame: 56 weeks
Time frame: Baseline, Week 12, Week 24, Week 48, at the time of withdrawal up to approximately 48 weeks
Time frame: Baseline, predose (Hour 0) on Weeks 2, 4, 8, 12, 16, 24, 48
Time frame: Baseline, predose (Hour 0) on Weeks 2, 4, 8, 12, 16, 24, 48
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) on Day 0, 14, 84, and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) and 6-hours postdose on Day 0, Day 84; predose (Hour 0) on Day 14 and 98; on Day 1, 2, 3, 5, 7, 10, 85, 86, 87, 89, 91, and 94
Time frame: predose (Hour 0) on Day 14, 84
Time frame: predose (Hour 0) on Day 0, 14, 28, 56, 84, 98, 112, 140, 168, and 336
Time frame: Week 24
Time frame: Week 24
Hoffmann-La Roche
Industry
A Randomized, Multi-Center, Double Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of Subcutaneous (SC) Tocilizumab (TCZ) in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Patients With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current DMARD Therapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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