An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response or Intolerance to One Anti-Tumor Necrosis Factor (Anti-TNF) Agent

NCT01641952 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 505

Last updated 2016-08-17

Study results available
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Summary

This observational, prospective, multicenter study will evaluate the efficacy and safety of MabThera/Rituxan in participants with active rheumatoid arthritis and an inadequate response or intolerance to one anti-TNF therapy. Participants who receive MabThera/Rituxan according to the current standard and in line with the summary of product characteristics at a dose of 1000 milligram (mg) intravenously on Days 1 and 15 will be followed for 20 weeks.

Conditions

Interventions

DRUG

Rituximab

Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Romania

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01641952 on ClinicalTrials.gov