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A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)

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Roche

Status and phase

Completed
Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: rituximab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01272908
ML20381

Details and patient eligibility

About

This study will evaluate the safety and effectiveness of MabThera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-TNF therapy. All patients will receive MabThera 1000 mg as an intravenous infusion on days 1 and 15. After the initial study phase of 24 weeks, eligible patients may receive one re-treatment with MabThera. The anticipated time on study treatment is 48 weeks.

Enrollment

120 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients, 18-80 years of age
  • Moderate to severe active rheumatoid arthritis
  • Inadequate response to a single previous or current treatment with an anti-TNF agent
  • Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks

Exclusion criteria

  • Previous treatment with MabThera
  • Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
  • Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
  • Active infection, or history of serious or chronic infection

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Single arm
Experimental group
Treatment:
Drug: rituximab

Trial contacts and locations

41

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Data sourced from clinicaltrials.gov

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