Clinical trial NCT01565122: An Observational Study in Rheumatoid Arthritis Patients Treated With RoActemra/Actemra (Tocilizumab)
Official title: An Observational, Non-interventional, Multi-national Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-03-28
Enrollment: 51
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 initiated on RoActemra/Actemra treatment

Brief summary: This multi-center, observational study will evaluate the clinical practice patterns, efficacy and safety of RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected from each eligible patient initiated on RoActemra/Actemra treatment by their treating physician according to approved label for up to 12 months from start of treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis
* Patients for whom the treating physician has made the decision to commence RoActemra/Actemra treatment. In Group A RoActemra/Actemra has been prescribed within 8 weeks prior to the enrolment visit. In Group B RoActemra/Actemra has been started more than 8 weeks before inclusion in the study, but not before January 2011

Exclusion Criteria:

* RoActemra/Actemra treatment more than 8 weeks prior to inclusion visit for Group A, before January 2011 for Group B
* Previous RoActemra/Actemra treatment in a clinical trial or for compassionate use
* 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
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Primary outcomes:
measure: Proportion of patients on RoActemra/Actemra treatment at 6 months
timeFrame: approximately 2.5 years
Secondary outcomes:
measure: Rates of dose modifications/interruptions
timeFrame: approximately 2.5 years
measure: Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment
timeFrame: approximately 2.5 years
measure: Efficacy: Response according to joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR
timeFrame: approximately 2.5 years
measure: Efficacy: Monotherapy versus combination therapy
timeFrame: approximately 2.5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 2.5 years
measure: Quality of life: Patient global assessment of disease activity/VAS-Fatigue/VAS-Pain scales
timeFrame: approximately 2.5 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
city: Joensuu
country: Finland
city: Jyväskylä
country: Finland
city: Kuopio
country: Finland
city: Lahti
country: Finland
city: Paimio
country: Finland
city: Riihimäki
country: Finland
city: Rovaniemi
country: Finland
city: Tampere
country: Finland
city: Vaasa
country: Finland
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: