An Observational Study of RoActemra/Actemra (Tocilizumab) in Smoking Versus Non-Smoking Patients With Rheumatoid Arthritis

An Observational Study of the Efficacy of RoActemra in Smoking vs Non-smoking Patients With Rheumatoid Arthritis.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337388

Enrollment

197

Registered

2011-04-18

Start date

2010-08-31

Completion date

2013-10-31

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 assess the efficacy and safety of RoActemra/Actemra (Tocilizumab) in smoking versus non-smoking patients with rheumatoid arthritis. Data from patients treated in routine clinical practice with intravenous RoActemra/Actemra will be collected for 12 months each.

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 * Rheumatoid arthritis, defined as fulfilling at least 4 of 7 American College of Rheumatology (ACR) criteria * Treatment with RoActemra/Actemra

Exclusion criteria

* Participation in interventional clinical studies

Design outcomes

Primary

Measure	Time frame
Change in disease activity score (DAS 28)	12 months
Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice	36 months

Secondary

Measure	Time frame
Rate of patients achieving remission (DAS <2.6)	36 months
Safety: Incidence of adverse events	36 months
Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate	36 months
Change in blood lipids	12 months
Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire	12 months

Countries

Norway, Sweden

Outcome results