Clinical trial
A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate…
NCT01007435 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT01007435 |
|---|---|
| Title | A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis |
| Official title | A Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission and Prevention of Structural Joint Damage During Treatment With Tocilizumab (TCZ), as a Monotherapy and in Combination With Methotrexate (MTX), Versus Methotrexate in Patients With Early, Moderate to… |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Rheumatoid Arthritis |
| Intervention type | Drug |
| Interventions | Tocilizumab, Placebo to tocilizumab, Methotrexate, Placebo to methotrexate |
| Enrollment | 1,162 |
| Start date | Oct 31, 2009 |
| Primary completion | May 31, 2012 |
| Completion | Jan 28, 2014 |
| First posted | Nov 4, 2009 |
| Last update posted | Jul 26, 2017 |
| Countries | Argentina, Australia, Austria, Brazil, Canada, China, Colombia, Denmark, Finland, France, Germany, Greece and 24 more |
At a glance
- 100–999 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: