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An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

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Roche

Status

Completed

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Industry

Identifiers

NCT01557348
MA22401

Details and patient eligibility

About

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

Enrollment

1,239 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
  • Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion criteria

  • Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment

Trial design

1,239 participants in 2 patient groups

Rituximab
Description:
Eligible participants will receive rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
Alternative TNFi
Description:
Eligible participants will receive alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.

Trial contacts and locations

215

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Data sourced from clinicaltrials.gov

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