An observational study in Rheumatoid Arthritis, sponsored by Hoffmann-La Roche. Completed at 18 sites in Hungary. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-06.
Sponsored by Hoffmann-La Roche · Observational
The aim of this non-interventional study in Hungarian participants is to gather real life data about the efficacy and safety of tocilizumab SC monotherapy in RA, to assess data about pattern of usage of tocilizumab monotherapy in RA disease management.
3,554 studies on the registry are indexed under Arthritis; 318 are open to participants now.
This study's enrollment of 353 is above 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 receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current SPC/local labeling and who have no contraindication to tocilizumab therapy as per the local label. This can include participants who have received tocilizumab SC monotherapy treatment within 8 weeks prior to the enrollment visit.
Exclusion Criteria:
Participants from routine clinical practice in Hungary who are receiving treatment for RA with tocilizumab SC according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling and who have no contraindication to tocilizumab therapy as per the local label are eligible for observation.
Drug: Tocilizumab
Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
Also known as: RoActemra
Change in Disease Activity Score 28 (DAS28) from Baseline to End of Study
Time frame: Baseline, end of study (up to 24 weeks)
Change in Clinical Disease Activity Index (CDAI) Score from Baseline to End of Study
Time frame: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission, as Defined by DAS28 Less Than or Equal to (≤) 2.6
Time frame: Up to 24 weeks
Percentage of Participants Achieving CDAI Remission, as Defined by CDAI ≤2.8
Time frame: Up to 24 weeks
Change in DAS28 from Baseline to End of Study in Different Monotherapy Subgroups
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing disease-modifying antirheumatic drugs (DMARDs), 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Time frame: Baseline, end of study (up to 24 weeks)
Percentage of Participants Achieving DAS28 Remission in Different Monotherapy Subgroups, as Defined by DAS28 ≤2.6
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Time frame: Up to 24 weeks
Number of Tocilizumab SC Injections per Participant During Observational Treatment Period
Time frame: Up to 24 weeks
Percentage of Participants Who Discontinued Tocilizumab, Categorized by the Reasons for the Discontinuations
Time frame: Up to 24 weeks
Percentage of Participants on SC Tocilizumab First Line Monotherapy
Time frame: Up to 24 weeks
Percentage of Participants with Reasons for SC Tocilizumab Monotherapy
Time frame: Up to 24 weeks
Percentage of Participants Treated Previously with a Tumor Necrosis Factor (TNF) Inhibitor/Other Biologic and Low Dose Methotrexate (Less Than 10 Milligrams/Week)
Time frame: Up to 24 weeks
Percentage of Participants with Other DMARDs Than Methotrexate Before Tocilizumab Monotherapy Initiation and at End of Observation Period
Time frame: Baseline, Week 24
Percentage of Participants with Oral Steroid at Initiation of Tocilizumab SC Therapy and at End of Study
Time frame: Baseline, Week 24
Percentage of Participants With Steroid Dose Reductions/Withdrawal at End of Observation Period
Time frame: Week 24
Percentage of Participants with Steroid Tapering in Different Monotherapy Subgroups Who Achieved DAS28 Remission
The following 3 monotherapy subgroups will be included: 1) participants starting tocilizumab after failing DMARDs, 2) participants starting tocilizumab after failing one biologic, 3) participants starting tocilizumab after failing two or more biologics.
Time frame: Up to 24 weeks
Percentage of Participants with Adverse Events
Time frame: Up to 24 weeks
This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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