Clinical trial NCT01952509: A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) Treatment in Patients With Rheumatoid Arthritis
Official title: Multinational, Multicenter, Non Interventional Study, in Patients With Rheumatoid Arthritis (RA) Treated With Tocilizumab.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-09-30
Enrollment: 169
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 moderate to severe rheumatoid arthritis initiating treatment with RoActemra/Actemra in accordance with the local label

Brief summary: This multicenter, observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in routine clinical practice in patients with moderate to severe rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment in accordance with the local label will be followed for 6 months.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment (in accordance with the local label); this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation
timeFrame: approximately 2 years
Secondary outcomes:
measure: Rates of dose modifications/interruptions
timeFrame: approximately 2 years
measure: Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
timeFrame: approximately 2 years
measure: Proportion of patients on RoActemra/Actemra monotherapy at study entry and at Month 6
timeFrame: approximately 2 years
measure: Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
timeFrame: approximately 2 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 years
measure: Health Assessment Questionnaire Disability Index
timeFrame: approximately 2 years
measure: Visual Analogue Scale - Fatigue
timeFrame: approximately 2 years
measure: Visual Analogue Scale - severity of pain
timeFrame: approximately 2 years
measure: Visual Analogue Scale - morning stiffness
timeFrame: aproximately 2 years
measure: Patient Global Assessment of disease activity
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Cartago
country: Costa Rica
city: San Jose
country: Costa Rica
city: Santo Domingo
country: Dominican Republic
city: Ciudad de Guatemala
country: Guatemala
city: Panama City
country: Panama
city: Panama
country: Panama
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: