An Observational Study of RoActemra/Actemra in Patients With Moderate to Severe Rheumatoid Arthritis
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)
1 other identifier
observational
197
1 country
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2011
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 16, 2011
CompletedFirst Posted
Study publicly available on registry
June 17, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedNovember 2, 2016
November 1, 2016
1 year
June 16, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients who remained under continued RoActemra/Actemra treatment
6 months
Secondary Outcomes (5)
Reasons for withdrawal
6 months
Frequency of withdrawal
6 months
Frequency of dose modification
6 months
Reasons for dose modification
6 months
Safety: Incidence of adverse events
6 months
Study Arms (1)
Cohort
Eligibility Criteria
Patients with rheumatoid arthritis
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Athens, 11521, Greece
Unknown Facility
Athens, 14527, Greece
Unknown Facility
Athens, 155 62, Greece
Unknown Facility
Crete, 71110, Greece
Unknown Facility
Pátrai, 26335, 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
Unknown Facility
Thessaloniki, 54643, Greece
Unknown Facility
Thessaloniki, 56429, Greece
Unknown Facility
Voula, 16673, 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
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2011
First Posted
June 17, 2011
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11