drugset
drugset / Trial / NCT01587989

A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

NCT01587989 ↗

Phase 3 Completed 77 enrolled Hoffmann-La Roche
RandomizedParallel-groupDouble-blindTreatment

Summary

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Timeline

Start
2012-02
Primary completion
2014-02
Completion
2014-02

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Group A: TCZ + MTX vs Group B: TCZ + Placebo; p = 0.015; ANCOVA NCT01587989 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methotrexate Small molecule 15 mg Oral
Comparator Methotrexate Small molecule 25 mg Oral
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous

Indications

rheumatoid arthritis