An Observational Study of RoActemra/Actemra (Tocilizumab) in Rheumatoid Arthritis Patients
A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
1 other identifier
observational
60
1 country
9
Brief Summary
This multi-center, observational study will evaluate the use in clinical practice and efficacy of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started May 2012
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
June 6, 2012
CompletedFirst Posted
Study publicly available on registry
June 8, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1.5 years
June 6, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients on RoActemra/Actemra treatment at 6 months
approximately 2 years
Secondary Outcomes (5)
Rates of dose modifications/interruptions
approximately 2 years
Clinical/demographic patient characteristics at initiation of treatment
approximately 2 years
Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
approximately 2 years
Efficacy: Monotherapy versus combination therapy
approximately 2 years
Use of disease-modifying anti-rheumatic drugs (DMARDs)
approximately 2 years
Study Arms (1)
Cohort
Eligibility Criteria
Patients with rheumatoid arthritis initiating treatment with RoActemra/Actemra
You may qualify if:
- Adult patients, \>/= 18 years of age
- Moderate to severe rheumatoid arthritis , according to the revised ACR criteria
- Patients initiated on RoActemra/Actemra treatment (in accordance with the local label) on their treating physicians decision
You may not qualify if:
- RoActemra/Actemra treatment more than 8 weeks prior to 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 investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
- History of autoimmune disease or of any joint inflammatory disease other than RA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Unknown Facility
Athens, 11 527, Greece
Unknown Facility
Athens, 115 27, Greece
Unknown Facility
Athens, 11527, Greece
Unknown Facility
Larissa, 411 10, Greece
Unknown Facility
Pátrai, 26443, Greece
Unknown Facility
Pátrai, 265 04, Greece
Unknown Facility
Rhodes, 851 00, Greece
Unknown Facility
Thessaloniki, 546 42, Greece
Unknown Facility
Thessaloniki, 54636, Greece
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2012
First Posted
June 8, 2012
Study Start
May 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11