# A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis

> **NCT01007435** · PHASE3 · COMPLETED · sponsor: **Hoffmann-La Roche** · enrollment: 1162 (actual)

## Conditions studied

- Rheumatoid Arthritis

## Interventions

- **DRUG:** Tocilizumab
- **DRUG:** Placebo to tocilizumab
- **DRUG:** Methotrexate
- **DRUG:** Placebo to methotrexate

## Key facts

- **NCT ID:** NCT01007435
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2009-10-31
- **Primary completion:** 2012-05-31
- **Final completion:** 2014-01-28
- **Target enrollment:** 1162 (ACTUAL)
- **Last updated:** 2017-07-26


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01007435

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01007435, "A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis". Retrieved via AI Analytics 2026-06-01 from https://api.ai-analytics.org/clinical/NCT01007435. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*