Clinical trial NCT01338545: An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)
Official title: A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-04-19
Enrollment: 400
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 after at least one previous DMARD or TNF-inhibitor treatment

Brief summary: This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
* Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
* Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications

Exclusion Criteria:

* History of autoimmune disease or of any joint inflammatory disease other than RA
* Pregnant or lactating women
* Patients who have started RoActemra treatment in a clinical trial or for compassionate use
* Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)

Primary outcomes:
measure: Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
timeFrame: 12 months
Secondary outcomes:
measure: Safety: Incidence of adverse events
timeFrame: 12 months
measure: Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)
timeFrame: 12 months
measure: Response rate according to EULAR (European League Against Rheumatism) criteria
timeFrame: 12 months
measure: Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)
timeFrame: 12 months
measure: Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors
timeFrame: 12 months
measure: Effect on DMARD tolerance/dosage in combination therapy
timeFrame: 12 months
measure: Dosages used in clinical practice
timeFrame: 12 months
Other outcomes:
Locations:
city: Coral Springs
country: United States
state: Florida
city: Elche
country: Spain
state: Alicante
city: Elda
country: Spain
state: Alicante
city: Sabadell
country: Spain
state: Barcelona
city: Sant Joan Despi
country: Spain
state: Barcelona
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Santander
country: Spain
state: Cantabria
city: Torrelavega
country: Spain
state: Cantabria
city: Vinaroz
country: Spain
state: Castellon
city: San Sebastian
country: Spain
state: Guipuzcoa
city: La Coruna
country: Spain
state: La Coruña
city: Santiago de Compostela
country: Spain
state: La Coruña
city: Logroño
country: Spain
state: La Rioja
city: Alcala de Henares
country: Spain
state: Madrid
city: Alcorcon
country: Spain
state: Madrid
city: San Lorenzo De El Escorial
country: Spain
state: Madrid
city: Cartagena
country: Spain
state: Murcia
city: El Palmar
country: Spain
state: Murcia
city: Lorca
country: Spain
state: Murcia
city: Pamplona
country: Spain
state: Navarra
city: Ourense
country: Spain
state: Orense
city: Vigo
country: Spain
state: Pontevedra
city: Alzira
country: Spain
state: Valencia
city: San Juan
country: Spain
state: Valencia
city: Valenica
country: Spain
state: Valencia
city: Barakaldo
country: Spain
state: Vizcaya
city: Bilbao
country: Spain
state: Vizcaya
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Cordoba
country: Spain
city: Girona
country: Spain
city: Granada
country: Spain
city: Granada
country: Spain
city: Huelva
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Murcia
country: Spain
city: Sevilla
country: Spain
city: Toledo
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: