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

Hoffmann-La Roche197 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

197

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Unnamed facility

Ålesund, Norway

Unnamed facility

Bergen, Norway

Outcomes

Primary Outcomes

Change in disease activity score (DAS 28)

Time frame: 12 months

Treatment patterns (frequency/dosage) and demographics of patients treated with RoActemra/Actemra in routine clinical practice

Time frame: 36 months

Secondary Outcomes

Safety: Incidence of adverse events

Time frame: 36 months

Quality of life: Health assessment questionnaire Disease Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy- Fatigue (FACIT-Fatigue) questionnaire

Time frame: 12 months

Rate of patients achieving remission (DAS <2.6)

Time frame: 36 months

Change in blood lipids

Time frame: 12 months

Clinical response (DAS 28/blood chemistry/QoL) with or without methotrexate

Time frame: 36 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.