Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker

NCT ID: NCT02322801

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Patients with serious infections
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Pescara, Abruzzo, Italy

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Brindisi, Apulia, Italy

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Martina Franca, Apulia, Italy

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San Cesario di Lecce, Apulia, Italy

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San Daniele Del Friuli, Apulia, Italy

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Mormanno, Calabria, Italy

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Napoli, Campania, Italy

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Napoli, Campania, Italy

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Scafati, Campania, Italy

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Bologna, Emilia-Romagna, Italy

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Parma, Emilia-Romagna, Italy

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Piacenza, Emilia-Romagna, Italy

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Gorizia, Friuli Venezia Giulia, Italy

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Trieste, Friuli Venezia Giulia, Italy

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Albano Laziale, Lazio, Italy

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Rieti, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Viterbo, Lazio, Italy

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Arenzano, Liguria, Italy

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Savona, Liguria, Italy

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Cremona, Lombardy, Italy

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Legnano, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Monza, Lombardy, Italy

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Rozzano, Lombardy, Italy

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Cuneo, Piedmont, Italy

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Novara, Piedmont, Italy

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Pinerolo, Piedmont, Italy

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Turin, Piedmont, Italy

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Turin, Piedmont, Italy

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Cagliari, Sardinia, Italy

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Monserrato, Sardinia, Italy

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Catania, Sicily, Italy

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Catania, Sicily, Italy

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Palermo, Sicily, Italy

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Palermo, Sicily, Italy

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Arezzo, Tuscany, Italy

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Florence, Tuscany, Italy

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Massa, Tuscany, Italy

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Pisa, Tuscany, Italy

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Pontedera, Tuscany, Italy

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Prato, Tuscany, Italy

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Treviso, Veneto, Italy

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Valeggio sul Mincio, Veneto, Italy

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Venezia, Veneto, Italy

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Verona, Veneto, Italy

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Vicenza, Veneto, Italy

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Countries

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Italy

Other Identifiers

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ML21774

Identifier Type: -

Identifier Source: org_study_id