Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker
1 other identifier
observational
209
1 country
54
Brief Summary
This multi-center, observational, retrospective-prospective cohort study will investigate the safety of rituximab (MabThera) by collecting data from daily clinical practice on the use of rituximab and its relative clinical impact, particularly with regard to adverse events. Data from each patient will be collected over 24 months after enrolment in the study. Target sample size is up to 325 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2009
Typical duration for all trials
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 19, 2014
CompletedFirst Posted
Study publicly available on registry
December 23, 2014
CompletedNovember 2, 2016
November 1, 2016
2.7 years
December 19, 2014
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percent of patients with at least one grade 3 or 4 adverse event since starting RTX treatment and in the 24 months after study enrollment
Up to 31 months (24 months each patient)
Secondary Outcomes (6)
Percent of patients with at least one severe adverse event (SAE)
Up to 31 months (24 months each patient)
Percent of patients who discontinued therapy with RTX
Up to 31 months (24 months each patient)
Time to "re-treatment" with RTX
Up to 31 months (24 months each patient)
Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs
Up to 31 months (24 months each patient)
Time to response and duration of response to RTX
Up to 31 months (24 months each patient)
- +1 more secondary outcomes
Study Arms (1)
Cohort
Eligibility Criteria
Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha
You may qualify if:
- Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha and who started rituximab (RTX) treatment in the 12 months before site initiation and were still under treatment when enrollment starts
You may not qualify if:
- Patients with serious infections
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (54)
Unknown Facility
Pescara, Abruzzo, 65100, Italy
Unknown Facility
Brindisi, Apulia, 72100, Italy
Unknown Facility
Martina Franca, Apulia, 74015, Italy
Unknown Facility
San Cesario di Lecce, Apulia, 73016, Italy
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San Daniele Del Friuli, Apulia, 33038, Italy
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Mormanno, Calabria, 87026, Italy
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Napoli, Campania, 80131, Italy
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Napoli, Campania, 80144, Italy
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Scafati, Campania, 84018, Italy
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Bologna, Emilia-Romagna, 40138, Italy
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Parma, Emilia-Romagna, 43100, Italy
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Piacenza, Emilia-Romagna, 29100, Italy
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Gorizia, Friuli Venezia Giulia, 34170, Italy
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Trieste, Friuli Venezia Giulia, 34142, Italy
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Albano Laziale, Lazio, 00041, Italy
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Rieti, Lazio, 02100, Italy
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Rome, Lazio, 00128, Italy
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Rome, Lazio, 00133, Italy
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Rome, Lazio, 00135, Italy
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Rome, Lazio, 00152, Italy
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Rome, Lazio, 00153, Italy
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Rome, Lazio, 00189, Italy
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Viterbo, Lazio, 01100, Italy
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Arenzano, Liguria, 16011, Italy
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Savona, Liguria, 17100, Italy
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Cremona, Lombardy, 26100, Italy
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Legnano, Lombardy, 20025, Italy
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Milan, Lombardy, 20122, Italy
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Milan, Lombardy, 20161, Italy
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Milan, Lombardy, 20162, Italy
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Monza, Lombardy, 20052, Italy
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Rozzano, Lombardy, 20089, Italy
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Cuneo, Piedmont, 12100, Italy
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Novara, Piedmont, 28100, Italy
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Pinerolo, Piedmont, 10064, Italy
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Turin, Piedmont, 10126, Italy
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Turin, Piedmont, 10128, Italy
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Cagliari, Sardinia, 09042, Italy
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Monserrato, Sardinia, 09042, Italy
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Catania, Sicily, 95124, Italy
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Catania, Sicily, 95126, Italy
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Palermo, Sicily, 90127, Italy
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Palermo, Sicily, 90146, Italy
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Arezzo, Tuscany, 52100, Italy
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Florence, Tuscany, 50100, Italy
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Massa, Tuscany, 54100, Italy
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Pisa, Tuscany, 56100, Italy
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Pontedera, Tuscany, 56025, Italy
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Prato, Tuscany, 59100, Italy
Unknown Facility
Treviso, Veneto, 31100, Italy
Unknown Facility
Valeggio sul Mincio, Veneto, 37067, Italy
Unknown Facility
Venezia, Veneto, 30127, Italy
Unknown Facility
Verona, Veneto, 37134, Italy
Unknown Facility
Vicenza, Veneto, 36100, Italy
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
December 19, 2014
First Posted
December 23, 2014
Study Start
March 1, 2009
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11