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

Hoffmann-La Roche0 sites184 target enrollmentMay 2012

ConditionsRheumatoid Arthritis

InterventionsTocilizumab

DrugsTocilizumab

Overview

Phase: Not Applicable
Intervention: Tocilizumab
Conditions: Rheumatoid Arthritis
Sponsor: Hoffmann-La Roche
Enrollment: 184
Primary Endpoint: Percentage of Participants on TCZ Treatment at 6 Months After Treatment Initiation
Status: Completed
Last Updated: 10 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 in patients with rheumatoid arthritis who have had an inadequate response (or were intolerant to) treatment with non-biological DMARDs or with one biological agent. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for 6 months from start of treatment.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

March 2014

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Moderate to severe rheumatoid arthritis
•Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
•Patients initiating treatment with RoActemra/Actemra on their physician's decision (in accordance with the local label), including patients 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
•Enrolled in an ongoing clinical trial and/or 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

Cohort

Intervention: Tocilizumab

Outcomes

Primary Outcomes

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

Time Frame: 6 months

Percentage of Participants on TCZ Treatment at 5-6 Months After Treatment Initiation

Time Frame: 5-6 months

Secondary Outcomes

Percentage of Participants With Systemic Manifestations of RA at Baseline(Baseline)
Percentage of Participants Who Received DMARDs Prior to Start of Study and Concomitantly With TCZ During the Study(Prior to study start (8 weeks) and Baseline up to 6 months)
Percentage of Participants With Reason for DMARD Withdrawal(Up to 6 months)
Percentage of Participants Who Received Biological RA Treatment Prior to Start of Study(Prior to study start (8 weeks))
Percentage of Participants With Type of Previous Biologic RA Treatments(Up to 6 months)
Duration of Previous Biologic RA Treatments(Up to 6 months)
Percentage of Participants With Reasons for Termination of Previous Biologic RA Treatments(Up to 6 months)
Percentage of Participants With Dose Modifications(6 months)
Percentage of Participants With Reasons for Dose Modification(6 months)
Mean Dose at 6 Months(6 months)
Mean Number of Dose Modifications at 6 Months(6 months)
Mean Dosing Interval of Treatment at 6 Months(6 months)
Percentage of Participants Who Discontinued From TCZ for Safety Versus Efficacy(6 months)
Time to Restoration of Initial Dosing Regimen(6 months)
Percentage of Participants Who Adhered to the Dosing Regimen Recommended by Physician(6 months)
Percentage of Participants on TCZ Monotherapy(Up to 6 months)
Change From Baseline in Tender Joint Count (TJC) (68 Joints) at Month 6(Baseline, 6 months)
Change From Baseline in Swollen Joint Count (SJC) (66 Joints) at Month 6(Baseline, 6 months)
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS28) at Month 6(Baseline, 6 months)
Percentage of Participants With European League Against Rheumatism (EULAR) Response at Month 6(6 months)
Change From Baseline in Simplified Disease Activity Index (SDAI) Score at Month 6(Baseline, 6 months)
Change From Baseline in Clinical Disease Activity Index (CDAI) Score at Month 6(Baseline, 6 months)
Percentage of Participants Who Achieved 20% Improvement in ACR (ACR20) Response at Month 6(6 months)
Percentage of Participants Who Achieved 50% Improvement in ACR (ACR50) Response at Month 6(6 months)
Percentage of Participants Who Achieved 70% Improvement in ACR (ACR70) Response at Month 6(6 months)
Change From Baseline in CRP at Month 6(Baseline, 6 months)
Change From Baseline in ESR at Month 6(Baseline, 6 months)
Change From Baseline in PhGH at Month 6(Baseline, 6 months)
Change From Baseline in PGH of Disease Activity at Month 6(Baseline, 6 months)
Change From Baseline in HAQ-DI at Month 6(Baseline, 6 months)
Change From Baseline in Participant's Assessment of Fatigue Using VAS at Month 6(Baseline, 6 months)
Change From Baseline in Participant's Assessment of RA-Related Pain at Month 6(Baseline, 6 months)
Change From Administration 1 in Functional Assessment of Chronic Illness Therapy (FACIT)- Fatigue Questionnaire at Month 6(Administration 1 (Baseline), 6 months)
Change From Baseline in Morning Stiffness as Assessed Using VAS at Month 6(Baseline, 6 months)