An Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis Treated With Glucocorticoids
A Prospective Observational Study to Assess the Impact of RoActemra® on the Use of Glucocorticoids in Patients With Rheumatoid Arthritis Treated With the Standard of Care.
1 other identifier
observational
23
1 country
13
Brief Summary
This prospective, observational, multicenter study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) on the use of glucocorticoids in patients with moderate to severe rheumatoid arthritis and an inadequate response to previous disease-modifying antirheumatic drugs or anti-TNF. Data will be collected for 36 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2012
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
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 28, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 2, 2016
November 1, 2016
9 months
February 16, 2012
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
Week 36
Secondary Outcomes (11)
Change from baseline in glucocorticoid dose
Week 36
Change from baseline in corticosteroid dose
Week 36
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
Week 36
- +6 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids
You may qualify if:
- Adults patients, over 18 years of age
- Patients with moderate to severe rheumatoid arthritis (RA)
You may not qualify if:
- Patients previously treated with RoActemra/Actemra
- Any contraindication to RoActemra/Actemra
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Vitoria-Gasteiz, Alava, 01009, Spain
Unknown Facility
Alicante, Alicante, 03700, Spain
Unknown Facility
Elche, Alicante, 03203, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Unknown Facility
Huesca, Huesca, 22004, Spain
Unknown Facility
León, Leon, 24071, Spain
Unknown Facility
Ponferrada, Leon, 24411, Spain
Unknown Facility
Salamanca, Salamanca, 37007, Spain
Unknown Facility
Alzira, Valencia, 46600, Spain
Unknown Facility
Valencia, Valencia, 46340, Spain
Unknown Facility
Valencia, Valencia, 46520, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
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
February 16, 2012
First Posted
March 28, 2012
Study Start
January 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11