A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01770834

Enrollment

100

Registered

2013-01-18

Start date

2013-04-18

Completion date

2017-01-25

Last updated

2018-03-02

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 prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adult patients, \>/= 21 years of age * Moderate to severe active rheumatoid arthritis (DAS28 \>/= 3.2) * Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) * Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion criteria

* Pregnant or lactating women * Contra-indication to RoActemra/Actemra treatment according to the local labelling * Previous treatment with tocilizumab * 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 * Women of childbearing potential not using effective methods of contraception as defined by protocol

Design outcomes

Primary

Measure	Time frame
Safety: Incidence of adverse events	approximately 3 years

Secondary

Measure	Time frame
Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6)	approximately 3 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment	approximately 3 years
Treatment regimens: Concomitant medications	approximately 3 years

Countries

Kuwait, Lebanon, Qatar, United Arab Emirates

Outcome results