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Clinical Trials/NCT01375478
NCT01375478CompletedNot Applicable

Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION Study)

Hoffmann-La Roche0 sites197 target enrollmentStarted: April 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
197
Primary Endpoint
Percentage of patients who remained under continued RoActemra/Actemra treatment

Study Overview

Brief Summary

This open-label, retrospective, observational study will evaluate the compliance to RoActemra/Actemra (tocilizumab) therapy in patients with moderate to severe rheumatoid arthritis. Six months data will be collected from patients records.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Adult patients, over 18 years of age
  • Moderate to severe rheumatoid arthritis
  • RoActemra/Actemra treatment must have been initiated 6 months prior to signing the informed consent form

Exclusion Criteria

  • Patients with rheumatic autoimmune disease other than rheumatoid arthritis
  • Patients who are not willing to sign the informed consent form
  • Patients who participate in interventional trials during the period of this observational study

Outcomes

Primary Outcomes

Percentage of patients who remained under continued RoActemra/Actemra treatment

Time Frame: 6 months

Secondary Outcomes

  • Frequency of dose modification(6 months)
  • Reasons for withdrawal(6 months)
  • Reasons for dose modification(6 months)
  • Safety: Incidence of adverse events(6 months)
  • Frequency of withdrawal(6 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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