An Observational Study on Long-Term Efficacy and Safety of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis (FAct)

FAct: A Non-interventional Multi-center Study to Follow Patients Starting With RoActemra Assessing the Long Term Efficacy, Effectiveness and Safety of RoActemra

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01483326

Enrollment

215

Registered

2011-12-01

Start date

2010-12-31

Completion date

2017-06-19

Last updated

2019-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

This observational study will evaluate the long-term efficacy and safety of RoActemra/Actemra (tocilizumab in participants of the ACT SURE clinical trial and further patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra. Data will be collected from each patient for up to 4 years.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>18 years of age * Participants in the ACT-SURE trial, or patients with moderate to severe rheumatoid arthritis starting or receiving RoActemra/Actemra

Exclusion criteria

* Contra-indications for RoActemra/Actemra

Design outcomes

Primary

Measure	Time frame
Change in disease activity score (DAS 28)	baseline and up to 4 years

Secondary

Measure	Time frame
Change in disability, assessed by Health Assessment Questionnaire (HAQ)	baseline and up to 4 years
Change in concomitant medication (especially tapering of steroids)	baseline and up to 4 years
Change in dosage schedule (modification/interruption/discontinuation)	baseline and up to 4 years
Safety: Incidence of adverse events	up to 4 years
Response (DAS 28) according to patient-related factors (C-reactive protein, rheumatoid factor, inadequate response to anti-TNF/DMARDs, duration of illness)	up to 4 years

Countries

Netherlands

Outcome results