An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 13 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Observational
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 23 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with moderate to severe rheumatoid arthritis and concomitant treatment with glucocorticoids
Exclusion Criteria:
Proportion of patients on treatment with RoActemra/Actemra who achieve prednisone (or equivalent) dose reduction of </= 5mg/day
Time frame: Week 36
Change from baseline in glucocorticoid dose
Time frame: Week 36
Change from baseline in corticosteroid dose
Time frame: Week 36
Proportion of patients treated with RoActemra/Actemra who reach Week 36 with a reduced glucocorticoid dose
Time frame: Week 36
Proportion of patients treated with RoActemra/Actemra not receiving glucocorticoids
Time frame: Week 36
Proportion of concomitant disease-modifying anti-rheumatic drug (DMARD) use
Time frame: Week 36
Proportion of patients with inadequate response to prior treatment with disease-modifying antirheumatic drugs at baseline, who reach a prednisone (or equivalent) dose reduction of </= 5 mg/day
Time frame: Week 36
Proportion of patients with inadequate response to prior treatment with anti-TNF at baseline, who reach a glucocorticoid dose reduction of </= 5 mg/day
Time frame: Week 36
Proportion of patients meeting the physician's recommendaitons for glucocorticoid dose reduction
Time frame: Week 36
Percentage change in Disease Activity Score 28 (DAS28)
Time frame: Week 36
Percentage change in Simplified Disease Activity Index (SDAI) score
Time frame: Week 36
Safety: Incidence of adverse events
Time frame: 36 weeks
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hoffmann-La Roche