An Observational Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (ACTIVATE)

An Open-label, Multicenter Non-interventional Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Combination With Methotrexate in Patients With Rheumatoid Arthritis

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01384461

Enrollment

251

Registered

2011-06-29

Start date

2011-01-31

Completion date

2013-05-31

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 safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate in patients with moderate to severe rheumatoid arthritis. Data will be collected for 12 months from patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) and methotrexate (weekly dose at the discretion of the physician).

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 * RoActemra/Actemra treatment initiated by rheumatologist in an Arthritis Center for (up to 2 months prior to study entry)

Exclusion criteria

* History of severe allergic or anaphylactic reactions or known hypersensitivity to any component of the drug * Active, severe infection or history of recurrent clinically significant infection * Pregnancy * Treatment with an investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before baseline visit * Methotrexate intolerance

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	12 months

Secondary

Measure	Time frame
Efficacy: Disease Activity Score (DAS 28)	12 months
Pain: Visual Analogue Scale (VAS) pain scale	12 months
Physical Function: Health Assessments Questionnaire (HAQ)	12 months
Incidence of patients with all-cause discontinuation of tocilizumab	12 months

Countries

Hungary

Outcome results