# A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy

> **NCT00468546** · PHASE3 · COMPLETED · sponsor: **Hoffmann-La Roche** · enrollment: 520 (actual)

## Conditions studied

- Rheumatoid Arthritis

## Interventions

- **DRUG:** MabThera/Rituxan
- **DRUG:** Methotrexate
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT00468546
- **Lead sponsor:** Hoffmann-La Roche
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2003-05
- **Primary completion:** 2005-01
- **Final completion:** 2012-07
- **Target enrollment:** 520 (ACTUAL)
- **Last updated:** 2016-10-25

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00468546

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00468546, "A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT00468546. Licensed CC0.

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