A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab Actemra

Hoffmann-La Roche0 sites50 target enrollmentFebruary 2012

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Not Applicable
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 50
Primary Endpoint: Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in participants with moderate to severe rheumatoid arthritis. Data will be collected from each eligible participant initiated on RoActemra/Actemra treatment by their treating physician according to local label for 6 months from start of treatment.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

March 2014

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult participants, \>/= 18 years of age
•Moderate to severe rheumatoid arthritis
•Participants initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including participants who started treatment with RoActemra/Actemra in the 8 weeks prior to the enrolment visit

Exclusion Criteria

•RoActemra/Actemra treatment more than 8 weeks prior to the enrolment visit
•Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
•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
•History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Arms & Interventions

Tocilizumab

Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.

Intervention: Tocilizumab

Outcomes

Primary Outcomes

Percentage of Participants on Tocilizumab Treatment at 6 Months After Treatment Initiation

Time Frame: 6 months after treatment initiation

Secondary Outcomes

Percentage of Participants With Systemic Manifestations of RA at Baseline(Baseline)
Percentage of Participants Who Discontinued From Tocilizumab for Safety Versus Efficacy(Approximately 3 years)
Percentage of Participants on Tocilizumab as Monotherapy or Combination Therapy(Baseline, Month 6)
Number of Participants Who Stopped Disease-Modifying Antirheumatic Drugs (DMARDs) Prior to Start of Tocilizumab(Baseline)
Percentage of Participants Who Previously Received DMARDs(Baseline)
Reason for DMARDs Withdrawal at Baseline(Baseline)
Number of Participants Who Stopped Biologic Agents Prior to Start of Tocilizumab(Baseline)
Percentage of Participants Who Previously Received Biologic Agents(Baseline)
Reason for Biologic Agent Withdrawal at Baseline(Baseline)
Reasons for Dose Modifications(approximately 3 years)
Change From Baseline in Tender Joint Count (TJC) at Month 3 and Month 6(Baseline, Month 3, Month 6)
Change From Baseline in Swollen Joint Count (SJC) at Month 3 and Month 6(Baseline, Month 3, Month 6)
Disease Activity Score-28 (DAS 28) Response Classification at Month 3 and Moth 6(Month 3, Month 6)
Clinical Disease Activity Index (CDAI) Response Classification at Month 3 and Month 6(Month 3, Month 6)
Simplified Disease Activity (SDAI) Response Classification(Month 3, Month 6)
European League Against Rheumatism (EULAR) Response(Month 3, Month 6)
Percentage of Participants With American College of Rheumatology (ACR) Response at Month 3 and Month 6(Month 3, Month 6)
Change From Baseline in Physician Global Assessment of Disease Activity at Month 3 and Month 6(Baseline, Month 3, Month 6)
Change From Baseline in Patient's Global Assessment of Disease Activity at Month 3 and Month 6(Baseline, Month 3, Month 6)
Percentage of Participants With Clinical Remission in Health Assessment Questionnaire Disability Index (HAQ-DI)(Baseline, Month 3, Month 6)
Change From Baseline in Patient's Global Assessment of Fatigue at Month 3 and Month 6(Baseline, Month 3, Month 6)
Change From Baseline in Patient's Global Assessment of Pain at Month 3 and Month 6(Baseline, Month 3, Month 6)
Change From Baseline in Patient's Severity of Morning Stiffness at Month 3 and Month 6(Baseline, Month 3, Month 6)
Percentage of Participants With an Adverse Event (AE)(approximately 3 years)