Rheumatoid Arthritis
Conditions
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.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| 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 | Up to 31 months (24 months each patient) |
Secondary
| Measure | Time frame |
|---|---|
| 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) |
| Percent of patients with at least one severe adverse event (SAE) | 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) |
| 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) |
| Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs | Up to 31 months (24 months each patient) |
Countries
Italy
Outcome results
None listed