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

Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02322801
• Other study ID #: ML21774
• Status: Completed
• Phase: N/A
• First received: December 19, 2014
• Last updated: November 1, 2016
• Start date: March 2009
• Est. completion date: November 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: AIFA (Italian National Competent Authority)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Percent of patients with at least one severe adverse event (SAE)		Up to 31 months (24 months each patient)	No
Secondary	Percent of patients who discontinued therapy with RTX		Up to 31 months (24 months each patient)	No
Secondary	Time to "re-treatment" with RTX		Up to 31 months (24 months each patient)	No
Secondary	Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs		Up to 31 months (24 months each patient)	No
Secondary	Time to response and duration of response to RTX		Up to 31 months (24 months each patient)	No
Secondary	Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline		Up to 31 months (24 months each patient)	No