A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)
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 II Study)
1 other identifier
observational
183
1 country
24
Brief Summary
This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.
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 May 2012
Shorter than P25 for all trials
24 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
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
July 23, 2012
CompletedFirst Posted
Study publicly available on registry
July 25, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedNovember 2, 2016
November 1, 2016
1 year
July 23, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment
12 months
Secondary Outcomes (3)
Frequency of withdrawal (according to reasons)
12 months
Frequency of dose modifications
12 months
Change in disease activity (DAS28)
from baseline to Month 6 or withdrawal, whichever comes first
Study Arms (1)
Cohort
Eligibility Criteria
Rheumatoid arthritis patients suitable for treatment with RoActemra/Actemra according to SPC
You may qualify if:
- Adult patients, \>/= 18 years of age
- Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
- RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
- Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis
You may not qualify if:
- Rheumatic autoimmune disease other than RA
- Participation in interventional clinical trials during the observational period
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
Unknown Facility
Agios Dimitrios, 17343, Greece
Unknown Facility
Agía Paraskeví, 15342, Greece
Unknown Facility
Argiroupoli, 16452, Greece
Unknown Facility
Athens, 11473, Greece
Unknown Facility
Athens, 11521, Greece
Unknown Facility
Athens, 155 62, Greece
Unknown Facility
Athens, Greece
Unknown Facility
Chalandri, Greece
Unknown Facility
Chania, 73134, Greece
Unknown Facility
Corinth, 20100, Greece
Unknown Facility
Eleusina, 19200, Greece
Unknown Facility
Herakleio, 71307, Greece
Unknown Facility
Ioannina, 455 00, Greece
Unknown Facility
Kifissia, Greece
Unknown Facility
Peristeri, 12934, Greece
Unknown Facility
Peuki, 15121, Greece
Unknown Facility
Rethymno, 74100, Greece
Unknown Facility
Serres, 62122, Greece
Unknown Facility
Thessaloniki, 54621, Greece
Unknown Facility
Thessaloniki, 54622, Greece
Unknown Facility
Thessaloniki, 54623, Greece
Unknown Facility
Thessaloniki, 54624, Greece
Unknown Facility
Thessaloniki, Greece
Unknown Facility
Volos, 38221, 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
July 23, 2012
First Posted
July 25, 2012
Study Start
May 1, 2012
Primary Completion
May 1, 2013
Study Completion
May 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11