An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)
An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
1 other identifier
observational
51
1 country
10
Brief Summary
This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.
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 Mar 2012
Typical duration for all trials
10 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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 26, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedNovember 2, 2016
November 1, 2016
2.2 years
March 26, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients on RoActemra/Actemra treatment at 6 months
approximately 2.5 years
Secondary Outcomes (6)
Rates of dose modifications/interruptions
approximately 2.5 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
approximately 2.5 years
Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
approximately 2.5 years
Efficacy: Monotherapy versus combination therapy
approximately 2.5 years
Safety: Incidence of adverse events
approximately 2.5 years
- +1 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Rheumatoid arthritis patients initiated on RoActemra/Actemra treatment
You may qualify if:
- Adult patients, \>/= 18 years of age
- Moderate to severe rheumatoid arthritis
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Unknown Facility
Helsinki, 00290, Finland
Unknown Facility
Joensuu, 80210, Finland
Unknown Facility
Jyväskylä, 40620, Finland
Unknown Facility
Kuopio, 70101, Finland
Unknown Facility
Lahti, 15850, Finland
Unknown Facility
Paimio, 21540, Finland
Unknown Facility
Riihimäki, 11101, Finland
Unknown Facility
Rovaniemi, 96101, Finland
Unknown Facility
Tampere, 33520, Finland
Unknown Facility
Vaasa, 65130, Finland
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
March 26, 2012
First Posted
March 28, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11