An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 15 sites in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Observational
The aim of this non-interventional, prospective, observational study is to assess the effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic treatment in participants with moderate to severe active RA who are inadequate responders to disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland. The length of the entire study will be 24 months.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 102 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.
Participants with a diagnosis of moderate to severe RA who are inadequate responders to DMARDs, or participants who are intolerant to DMARDs, in a routine clinical practice setting in Poland.
Exclusion Criteria:
N/A
Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.
Drug: Tocilizumab
Tocilizumab will be given according to summary of product characteristics as per clinical practice.
Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
Time frame: Month 6
Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment
Time frame: Month 6
Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
Time frame: Baseline up to Month 6
Time to Discontinuation
Time frame: Baseline up to Month 6
Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate
Time frame: Baseline up to Month 6
Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline
Time frame: Baseline
Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment
Time frame: Month 3
Change From Baseline in DAS28 Over Time
Time frame: Baseline up to Month 6
Change From Baseline in C-Reactive Protein (CRP) Over Time
Time frame: Baseline up to Month 6
Percentage of Participants With Discontinuations Due to Lack of Efficacy
Time frame: Baseline up to Month 6
Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)
Time frame: Baseline up to Month 6
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche