Completed PHASE3 INTERVENTIONAL 2-arm NCT00109408

A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Sponsor: Hoffmann-La Roche

Conditions Rheumatoid Arthritis

Interventions Methotrexate tocilizumab [RoActemra/Actemra]

Updated 7 times since 2017 Last updated: Nov 1, 2016 Started: Jul 31, 2005 Primary completion: Dec 31, 2007 Completion: Dec 31, 2007

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Rheumatoid Arthritis, this trial is completed. The trial is conducted by Hoffmann-La Roche and has accumulated 7 data snapshots since 2005. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jul 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Hoffmann-La Roche

Data source: Hoffmann-La Roche

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Albany, United States , Alcorcón, Spain , Almada, Portugal , Amarillo, United States , Ashkelon, Israel , Austin, United States , Barcelona, Spain , Baton Rouge, United States , Beersheba, Israel and 123 more locations