Clinical trial NCT01543503: An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis
Official title: A Global Comparative Observational Study In Rheumatoid Arthritis (RA) Patients Who Are Treated With A TNF Inhibitor Or Tocilizumab As The First Biologic Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-05
Enrollment: 1225
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: Adult patients with rheumatoid arthritis

Brief summary: This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Diagnosis of rheumatoid arthritis
* Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
* Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria:

* Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
* Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
* Patients whose first biologic is rituximab, abatacept or anakinra.
* Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit

Primary outcomes:
measure: Mean Change From Baseline in Calculated Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 24
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Mean Change From Baseline in Disease Activity Score Based on 28 Joint Count Erythrocyte Sedimentation Rate at Week 52
timeFrame: Baseline and Week 52
measure: Mean Change From Baseline in Erythrocyte Sedimentation Rate
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in C-reactive Protein
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Swollen Joint Count
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Tender Joint Count
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Clinical Disease Activity Index and Simplified Disease Activity Index Score
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Physician Global Assessment Score
timeFrame: Baseline, Week 24, Week 52
measure: Loss of Efficacy or Development of Intolerance to Biologic Therapy
timeFrame: Up to Week 52
measure: Proportion of Participants Who Terminated Biologic Treatment
timeFrame: Up to Week 52
measure: Reasons for Treatment Discontinuation
timeFrame: Up to Week 52
measure: Cumulative Number of Participants Who Discontinued Biologic Therapy at the End of Each Study Period
timeFrame: Up to end of treatment
measure: Number of Participants of Infusion Reactions or Injection Site Reactions During the Study Following the Start of the First Biologic Therapy
timeFrame: Up to Week 52
measure: Number of Participants With Adverse Events, Serious Adverse Events and Non-serious Adverse Events
timeFrame: Up to Week 52
measure: Number of Participants With Serious and Non-serious Adverse Events of Special Interest, Including Infections, During the Study
timeFrame: Up to Week 52
measure: Mean Change From Baseline in Health Assessment Questionnaire Disability Index Score
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue Score
timeFrame: Baseline, Week 24, Week 52
measure: Mean Change From Baseline in Visual Analogue Scale Pain Score
timeFrame: Baseline, Week 24, Week 52
measure: Shift From Baseline in Morning Stiffness
timeFrame: Baseline, Week 24, Week 52
measure: Change From Baseline in Patient Global Assessment of Disease Activity
timeFrame: Baseline, Week 24, Week 52
Other outcomes:
Locations:
city: Catamarca Capital
country: Argentina
city: Mendoza
country: Argentina
city: Mendoza
country: Argentina
city: Rosario
country: Argentina
city: Aalst
country: Belgium
city: Assebroek
country: Belgium
city: AYE
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Edegem
country: Belgium
city: Genk
country: Belgium
city: Gent
country: Belgium
city: Godinne
country: Belgium
city: Heusy
country: Belgium
city: Liège
country: Belgium
city: Oostende
country: Belgium
city: Verviers
country: Belgium
city: Westmalle
country: Belgium
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Bucaramanga
country: Colombia
city: Medellin
country: Colombia
city: Cuenca
country: Ecuador
city: Esmeraldas
country: Ecuador
city: Guayaquil
country: Ecuador
city: Portoviejo
country: Ecuador
city: Quito
country: Ecuador
city: Quito
country: Ecuador
city: Quito
country: Ecuador
city: Aachen
country: Germany
city: Bad Aibling
country: Germany
city: Bad Neuenahr-Ahrweiler
country: Germany
city: Bayreuth
country: Germany
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Erfurt
country: Germany
city: Erlangen
country: Germany
city: Fulda
country: Germany
city: Hamburg
country: Germany
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Herne
country: Germany
city: Köln
country: Germany
city: Ludwigsfelde
country: Germany
city: München
country: Germany
city: München
country: Germany
city: Passau
country: Germany
city: Rostock
country: Germany
city: Stuttgart
country: Germany
city: Traunstein
country: Germany
city: Wuppertal
country: Germany
city: Athens
country: Greece
city: Athens
country: Greece
city: Patra
country: Greece
city: Thessaloniki
country: Greece
city: Thessaloniki
country: Greece
city: Ciudad de Guatemala
country: Guatemala
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: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Salerno
country: Italy
state: Campania
city: Udine
country: Italy
state: Friuli-Venezia Giulia
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Arenzano
country: Italy
state: Liguria
city: Brescia
country: Italy
state: Lombardia
city: Legnano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Jesi Ancona
country: Italy
state: Marche
city: Agnone
country: Italy
state: Molise
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: Catania
country: Italy
state: Sicilia
city: Prato
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Mexicali
country: Mexico
city: Mexico Ctiy
country: Mexico
city: Panama City
country: Panama
city: Almada
country: Portugal
city: Amadora
country: Portugal
city: Lisboa
country: Portugal
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Porto
country: Portugal
city: Vila Nova de Gaia
country: Portugal
city: Fuenlabrada
country: Spain
state: Madrid
city: San Sebastian de los Reyes
country: Spain
state: Madrid
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Aarau
country: Switzerland
city: Basel
country: Switzerland
city: Chur
country: Switzerland
city: St. Gallen
country: Switzerland
city: Donetsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kmelnytskyy
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Kyiv
country: Ukraine
city: Odesa
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Zaporizhzhya
country: Ukraine
city: Barnsley
country: United Kingdom
city: Basildon
country: United Kingdom
city: Basingstoke
country: United Kingdom
city: Brighton
country: United Kingdom
city: Cannock
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Chertsey
country: United Kingdom
city: Crawley
country: United Kingdom
city: Darlington
country: United Kingdom
city: Enfield
country: United Kingdom
city: Grimsby
country: United Kingdom
city: Guildford
country: United Kingdom
city: Ipswich
country: United Kingdom
city: Kettering
country: United Kingdom
city: Lancaster
country: United Kingdom
city: Leeds
country: United Kingdom
city: Llandudno
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Luton
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Margate
country: United Kingdom
city: North Shields
country: United Kingdom
city: Oswestry
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Reading
country: United Kingdom
city: Rhyl
country: United Kingdom
city: Romford
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Stockport
country: United Kingdom
city: Sunderland
country: United Kingdom
city: Swindon
country: United Kingdom
city: Torquay
country: United Kingdom
city: Warrington
country: United Kingdom
city: Wirral
country: United Kingdom
city: Wolverhampton
country: United Kingdom
city: Wrightington
country: United Kingdom
city: Montevideo
country: Uruguay
city: Montevideo
country: Uruguay
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM. Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303. Epub 2017 Sep 6.