Clinical trial NCT01394276: An Observational Study on RoActemra/Actemra (Tocilizumab) in Clinical Practice in Patients With Rheumatoid Arthritis (TRUST)
Official title: Rheumatoid Arthritis Patients Treated With Tocilizumab in Real Clinical Practice: Effectiveness and Safety (TRUST Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-14
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra

Brief summary: This observational study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis. Data will be collected from patients for the 12 months following the first infusion of RoActemra/Actemra.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria
* Initiated on RoActemra/Actemra treatment according to the Summary of Product Characteristics not more than 6 months before opening of study center

Exclusion Criteria:

* Current serious infection
* Hypersensitivity to the active component or any of the excipients
* Pregnant women

Primary outcomes:
measure: Percentage of Participants Achieving Low Disease Activity After 6 Months of Treatment
timeFrame: Up to 12 months
measure: Percentage of Participants Achieving Disease Remission After 6 Months of Treatment
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean Score of Disease Activity Based on 28 Joint Count in Participants on Monotherapy With Tocilizumab
timeFrame: Baseline (Month 0), Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Mean Score of Fatigue Based on Visual Analogue Scale in Participants on Monotherapy With Tocilizumab
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Mean Score of Health Assessment Questionnaire in Participants on Monotherapy With Tocilizumab
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Number of Participants With Concomitant Medications
timeFrame: Up to 12 months
measure: Percentage of Participants Discontinuing Treatment With Tocilizumab
timeFrame: Up to 12 months
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to 12 months
measure: Percentage of Participants Still on Tocilizumab Treatment Till 12 Months After the 1st Infusion
timeFrame: Up to 12 months
measure: Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Right Hand.
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Right Hand.
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Second Metacarpo-phalangeal Joint of Left Hand
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Number of Participants With Presence and Severity of Synovial Hyperplasia, Joint Effusion and Vascularisation of Third Metacarpo-phalangeal Joint of Left Hand.
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Mean Disease Activity Score Based on 28 Joint Count Score in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Mean Score of Fatigue Based on Visual Analogue Scale in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
measure: Mean Score of Health Assessment Questionnaire in the Participants With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs and Anti-Tumor Necrosis Factors Agents
timeFrame: Baseline, Month 1, Month 2, Month 4, Month 6, and Month 12
Other outcomes:
Locations:
city: Coppito
country: Italy
state: Abruzzo
city: Pescara
country: Italy
state: Abruzzo
city: Reggio Calabria
country: Italy
state: Calabria
city: Avellino
country: Italy
state: Campania
city: Gragnano
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Salerno
country: Italy
state: Campania
city: Telese Terme
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Piacenza
country: Italy
state: Emilia-Romagna
city: Trieste
country: Italy
state: Friuli-Venezia Giulia
city: Albano Laziale
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: Castel Goffredo
country: Italy
state: Lombardia
city: Gavardo
country: Italy
state: Lombardia
city: Legnano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Rozzano
country: Italy
state: Lombardia
city: Saronno
country: Italy
state: Lombardia
city: Treviglio
country: Italy
state: Lombardia
city: Vimercate
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Jesi
country: Italy
state: Marche
city: Agnone
country: Italy
state: Molise
city: Cuneo
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Brindisi
country: Italy
state: Puglia
city: Casarano (LE)
country: Italy
state: Puglia
city: Foggia
country: Italy
state: Puglia
city: Martina Franca
country: Italy
state: Puglia
city: San Cesario Di Lecce
country: Italy
state: Puglia
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Gazzi
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Massa
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Prato
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Verona
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: