Clinical trial NCT02322801: Observational Safety Study of Rituximab in Patients Diagnosed With Rheumatoid Arthritis (RA) Who Did Not Respond Adequately to TNF-alpha Blocker
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2014-12-23
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with RA who did not respond adequately to anti-TNF-alpha

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Up to 31 months (24 months each patient)
Secondary outcomes:
measure: Percent of patients with at least one severe adverse event (SAE)
timeFrame: Up to 31 months (24 months each patient)
measure: Percent of patients who discontinued therapy with RTX
timeFrame: Up to 31 months (24 months each patient)
measure: Time to "re-treatment" with RTX
timeFrame: Up to 31 months (24 months each patient)
measure: Features of responders to RTX therapy in terms of co-morbidity and concomitant drugs
timeFrame: Up to 31 months (24 months each patient)
measure: Time to response and duration of response to RTX
timeFrame: Up to 31 months (24 months each patient)
measure: Percent of patients who achieve remission and relative quality of life (QoL) at 6, 12 and 24 months versus baseline
timeFrame: Up to 31 months (24 months each patient)
Other outcomes:
Locations:
city: Pescara
country: Italy
state: Abruzzo
city: Mormanno
country: Italy
state: Calabria
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Scafati
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Gorizia
country: Italy
state: Friuli-Venezia Giulia
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Albano Laziale
country: Italy
state: Lazio
city: Rieti
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Viterbo
country: Italy
state: Lazio
city: Arenzano
country: Italy
state: Liguria
city: Savona
country: Italy
state: Liguria
city: Cremona
country: Italy
state: Lombardia
city: Legnano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Rozzano
country: Italy
state: Lombardia
city: Cuneo
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Pinerolo
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Brindisi
country: Italy
state: Puglia
city: Martina Franca
country: Italy
state: Puglia
city: San Cesario Di Lecce
country: Italy
state: Puglia
city: San Daniele del Friuli
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Monserrato
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Catania
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Arezzo
country: Italy
state: Toscana
city: Firenze
country: Italy
state: Toscana
city: Massa
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Pontedera
country: Italy
state: Toscana
city: Prato
country: Italy
state: Toscana
city: Treviso
country: Italy
state: Veneto
city: Valeggio sul Mincio
country: Italy
state: Veneto
city: Venezia
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: Vicenza
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: