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

November 1, 2016 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

209

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
    • Calabria
      • Mormanno, Calabria, Italy, 87026
    • Campania
      • Napoli, Campania, Italy, 80131
      • Napoli, Campania, Italy, 80144
      • Scafati, Campania, Italy, 84018
    • Emilia-Romagna
      • Bologna, Emilia-Romagna, Italy, 40138
      • Parma, Emilia-Romagna, Italy, 43100
      • Piacenza, Emilia-Romagna, Italy, 29100
    • Friuli-Venezia Giulia
      • Gorizia, Friuli-Venezia Giulia, Italy, 34170
      • Trieste, Friuli-Venezia Giulia, Italy, 34142
    • Lazio
      • Albano Laziale, Lazio, Italy, 00041
      • Rieti, Lazio, Italy, 02100
      • Roma, Lazio, Italy, 00133
      • Roma, Lazio, Italy, 00152
      • Roma, Lazio, Italy, 00189
      • Roma, Lazio, Italy, 00128
      • Roma, Lazio, Italy, 00135
      • Roma, Lazio, Italy, 00153
      • Viterbo, Lazio, Italy, 01100
    • Liguria
      • Arenzano, Liguria, Italy, 16011
      • Savona, Liguria, Italy, 17100
    • Lombardia
      • Cremona, Lombardia, Italy, 26100
      • Legnano, Lombardia, Italy, 20025
      • Milano, Lombardia, Italy, 20122
      • Milano, Lombardia, Italy, 20162
      • Milano, Lombardia, Italy, 20161
      • Monza, Lombardia, Italy, 20052
      • Rozzano, Lombardia, Italy, 20089
    • Piemonte
      • Cuneo, Piemonte, Italy, 12100
      • Novara, Piemonte, Italy, 28100
      • Pinerolo, Piemonte, Italy, 10064
      • Torino, Piemonte, Italy, 10126
      • Torino, Piemonte, Italy, 10128
    • Puglia
      • Brindisi, Puglia, Italy, 72100
      • Martina Franca, Puglia, Italy, 74015
      • San Cesario Di Lecce, Puglia, Italy, 73016
      • San Daniele del Friuli, Puglia, Italy, 33038
    • Sardegna
      • Cagliari, Sardegna, Italy, 09042
      • Monserrato, Sardegna, Italy, 09042
    • Sicilia
      • Catania, Sicilia, Italy, 95126
      • Catania, Sicilia, Italy, 95124
      • Palermo, Sicilia, Italy, 90127
      • Palermo, Sicilia, Italy, 90146
    • Toscana
      • Arezzo, Toscana, Italy, 52100
      • Firenze, Toscana, Italy, 50100
      • Massa, Toscana, Italy, 54100
      • Pisa, Toscana, Italy, 56100
      • Pontedera, Toscana, Italy, 56025
      • Prato, Toscana, Italy, 59100
    • Veneto
      • Treviso, Veneto, Italy, 31100
      • Valeggio sul Mincio, Veneto, Italy, 37067
      • Venezia, Veneto, Italy, 30127
      • Verona, Veneto, Italy, 37134
      • Vicenza, Veneto, Italy, 36100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent of patients with at least one severe adverse event (SAE)
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)
Percent of patients who discontinued therapy with RTX
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)
Time to "re-treatment" with RTX
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)
Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)
Time to response and duration of response to RTX
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)
Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline
Time Frame: Up to 31 months (24 months each patient)
Up to 31 months (24 months each patient)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

December 19, 2014

First Submitted That Met QC Criteria

December 19, 2014

First Posted (Estimate)

December 23, 2014

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML21774

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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