An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)

Hoffmann-La Roche59 enrolled

Overview

This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult patients, \>/= 18 years of age * Moderate to severe active rheumatoid arthritis, defined as DAS28 \>/= 3.7 * Inadequate clinical response to current treatment with \>/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for \>/= 3 months, or inadequate clinical response to anti-TNF therapy * Eligible for RoActemra/Actemra treatment in daily clinical practice * Absence of evolutive tuberculosis (TB) Exclusion Criteria: * Hypersensitivity to tocilizumab or any of the excipients * Active, severe infections * Pregnant or lactating women * Participation in any other interventional study * Patients with major depression

Locations (18)

Unnamed facility

Aalst, Belgium

Unnamed facility

Assebroek, Belgium

Unnamed facility

Ath, Belgium

Outcomes

Primary Outcomes

Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16

Time frame: 16 months

Secondary Outcomes

Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue

Time frame: 16 months

Disease Activity Score DAS28

Time frame: 16 months

Pain: Visual Analogue Scale VAS Pain

Time frame: 16 months

Functional disability: Health Assessment Questionnaire HAQ

Time frame: 16 months

Quality of sleep: VAS

Time frame: 16 months

Anemia: Haemoglobin levels

Time frame: 16 months

Depression: Beck Depression Inventory (BDI) questionnaire

Time frame: 16 months

Data from ClinicalTrials.gov

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