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

F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01667458

Enrollment

Registered

2012-08-17

Start date

2011-09-30

Completion date

2012-12-31

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 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.

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 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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Disease Activity Score DAS28	16 months
Pain: Visual Analogue Scale VAS Pain	16 months
Functional disability: Health Assessment Questionnaire HAQ	16 months
Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue	16 months
Anemia: Haemoglobin levels	16 months
Depression: Beck Depression Inventory (BDI) questionnaire	16 months
Quality of sleep: VAS	16 months

Countries

Belgium, Luxembourg

Outcome results