An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01338545

Enrollment

400

Registered

2011-04-19

Start date

2010-07-31

Completion date

2012-09-30

Last updated

2016-11-02

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 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.

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 * 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)

Design outcomes

Primary

Measure	Time frame
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons	12 months

Secondary

Measure	Time frame
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)	12 months
Response rate according to EULAR (European League Against Rheumatism) criteria	12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)	12 months
Safety: Incidence of adverse events	12 months
Effect on DMARD tolerance/dosage in combination therapy	12 months
Dosages used in clinical practice	12 months
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors	12 months

Countries

Spain, United States

Outcome results