A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

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Roche

Status

Completed

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Industry

Identifiers

NCT01770834
ML25533

Details and patient eligibility

About

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Enrollment

100 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients, >/= 21 years of age
  • Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
  • Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
  • Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion criteria

  • Pregnant or lactating women
  • Contra-indication to RoActemra/Actemra treatment according to the local labelling
  • Previous treatment with tocilizumab
  • Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
  • Women of childbearing potential not using effective methods of contraception as defined by protocol

Trial design

100 participants in 1 patient group

Cohort

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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