Clinical trial NCT01557348: An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor
Official title: A Global Multi-centre Observational Study in RA Patients Who Are Non Responders or Intolerant to a Single TNF Inhibitor.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-19
Enrollment: 1239
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: Rheumatoid arthritis patients who are non-responders or intolerant to a single TNF-inhibitor

Brief summary: This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
* Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria:

* Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment

Primary outcomes:
measure: Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month 6
timeFrame: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 6
Secondary outcomes:
measure: Least Squares Mean Change From Baseline in Disease Activity Score (3 Variables)-Erythrocyte Sedimentation Rate at Month12
timeFrame: Baseline (Day of change in biologic therapy [<=Day 1]) and Month 12
measure: Least Squares Mean Change From Baseline in TJC at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in SJC at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in C-reactive Protein at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in ESR at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in Physician Global Assessment of Disease at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in Patient Global Assessment of Disease at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in Participant's VAS Pain Score at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in Health Assessment Questionnaire-Disability Index at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Least Squares Mean Change From Baseline in Duration of Morning Stiffness at Months 6 and 12
timeFrame: Baseline, Month 6, and Month 12
measure: Percentage of Participants Who Remained on Their Second Biologic Therapy at Months 6 and 12 After Start of Second Biologic Therapy
timeFrame: Month 6 and Month 12
measure: Reasons for Stopping the Second Biologic Therapy and Subsequent Therapy Choice
timeFrame: Up to 12 months
measure: Number of Participants With Any Adverse Events, Any Serious Adverse Event, Adverse Events Leading to Withdrawal, and Death
timeFrame: Up to 12 Months
measure: Number of Participants With Reasons for Discontinuation of the First TNFi Therapy
timeFrame: Day 1 (Study entry visit)
measure: Number of Participants With Previous TNFi Therapy
timeFrame: Day 1 (Study entry visit)
measure: Number of Participants With Previous Non-biologic Disease-modifying Anti-rheumatic Drugs Therapy
timeFrame: Day 1 (Study entry visit)
measure: Factors Related to Selection of Second Biologic Therapy Following an Insufficient Response or Intolerance to a Single Previous TNFi
timeFrame: Baseline
Other outcomes:
Locations:
city: Winnipeg
country: Canada
state: Manitoba
city: Saint John
country: Canada
state: New Brunswick
city: Brampton
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Hamilton
country: Canada
state: Ontario
city: Kitchener
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Mississauga
country: Canada
state: Ontario
city: St. Catharines
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Windsor
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
city: Rimouski
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Cali
country: Colombia
city: Abbeville
country: France
city: Aix Les Bains
country: France
city: Amiens
country: France
city: Amiens
country: France
city: Argenteuil
country: France
city: Bayonne
country: France
city: Belfort
country: France
city: Besancon
country: France
city: Bonneville
country: France
city: Bordeaux
country: France
city: Bordeaux
country: France
city: Boulogne-billancourt
country: France
city: Brest
country: France
city: Bruges
country: France
city: Bry Sur Marne
country: France
city: Caen
country: France
city: Cahors
country: France
city: Cambrai
country: France
city: Cannes
country: France
city: Carcassonne
country: France
city: Carhaix Plouguer
country: France
city: Chambray Les Tours
country: France
city: Clermont-Ferrand
country: France
city: Clermont-ferrand
country: France
city: Colmar
country: France
city: Corbeil-essonnes
country: France
city: Draguignan
country: France
city: Echirolles
country: France
city: Evreux
country: France
city: Issy Les Moulineaux
country: France
city: La Roche Sur Yon
country: France
city: La Source
country: France
city: Laon
country: France
city: Laval
country: France
city: Le Coudray
country: France
city: Le Kremlin Bicetre
country: France
city: Le Mans
country: France
city: Libourne
country: France
city: Lievin
country: France
city: Lille
country: France
city: Limoges
country: France
city: Limoges
country: France
city: Lomme
country: France
city: Lorient
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Maisons Laffitte
country: France
city: Mantes La Jolie
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Mennecy
country: France
city: Metz
country: France
city: Montauban
country: France
city: Montauban
country: France
city: Montivilliers
country: France
city: Montpellier
country: France
city: Mulhouse
country: France
city: Nantes
country: France
city: Nevers
country: France
city: Nice
country: France
city: Pachuca
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Reims
country: France
city: Reims
country: France
city: Rennes
country: France
city: Rodez
country: France
city: Roubaix
country: France
city: St Aubin Les Elbeuf
country: France
city: St Brieuc
country: France
city: St Priest En Jarez
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tours
country: France
city: Valence
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Villeneuve Sur Lot
country: France
city: Vincennes
country: France
city: Aachen
country: Germany
city: Bremen
country: Germany
city: Cuxhaven
country: Germany
city: Erlangen
country: Germany
city: Frankenberg
country: Germany
city: Frankfurt
country: Germany
city: Gräfelfing
country: Germany
city: Halle
country: Germany
city: Hannover
country: Germany
city: Köln
country: Germany
city: Münster
country: Germany
city: Neuss
country: Germany
city: Rostock
country: Germany
city: Villingen-Schwenningen
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Athens
country: Greece
city: Larissa
country: Greece
city: Coppito
country: Italy
state: Abruzzo
city: Potenza
country: Italy
state: Basilicata
city: Napoli
country: Italy
state: Campania
city: Telese Terme
country: Italy
state: Campania
city: Ferrara
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Ancona
country: Italy
state: Marche
city: Jesi
country: Italy
state: Marche
city: Bari
country: Italy
state: Puglia
city: San Cesario Di Lecce
country: Italy
state: Puglia
city: Gazzi
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Firenze
country: Italy
state: Toscana
city: Pisa
country: Italy
state: Toscana
city: Prato
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
city: Padova
country: Italy
state: Veneto
city: Verona
country: Italy
state: Veneto
city: Chihuahua
country: Mexico
city: Mexicali
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Mexico City
country: Mexico
city: Pozarica
country: Mexico
city: Monaco
country: Monaco
city: Ålesund
country: Norway
city: Amadora
country: Portugal
city: Guimaraes
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: El Palmar
country: Spain
state: Murcia
city: Lorca
country: Spain
state: Murcia
city: Cordoba
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Leon
country: Spain
city: Lugo
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Salamanca
country: Spain
city: Sevilla
country: Spain
city: Torrevieja
country: Spain
city: Abergavenny
country: United Kingdom
city: Aylesbury
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Cheltenham
country: United Kingdom
city: Chertsey
country: United Kingdom
city: Cosham
country: United Kingdom
city: Derby
country: United Kingdom
city: Durham
country: United Kingdom
city: Exeter
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Harrogate
country: United Kingdom
city: Inverness
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leeds
country: United Kingdom
city: Lincoln
country: United Kingdom
city: Liverpool
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Poole
country: United Kingdom
city: Salford
country: United Kingdom
city: Solihull
country: United Kingdom
city: Southport
country: United Kingdom
city: St Helens
country: United Kingdom
city: Stockport
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Sutton in Ashfield
country: United Kingdom
city: Torquay
country: United Kingdom
city: Truro
country: United Kingdom
city: Warrington
country: United Kingdom
city: Wirral
country: United Kingdom
city: Wolverhampton
country: United Kingdom
city: Worthing
country: United Kingdom
city: Wrightington
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: