Clinical trial NCT01667458: An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra

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.


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
timeFrame: 16 months
Secondary outcomes:
measure: Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue
timeFrame: 16 months
measure: Disease Activity Score DAS28
timeFrame: 16 months
measure: Pain: Visual Analogue Scale VAS Pain
timeFrame: 16 months
measure: Functional disability: Health Assessment Questionnaire HAQ
timeFrame: 16 months
measure: Quality of sleep: VAS
timeFrame: 16 months
measure: Anemia: Haemoglobin levels
timeFrame: 16 months
measure: Depression: Beck Depression Inventory (BDI) questionnaire
timeFrame: 16 months
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Assebroek
country: Belgium
city: Ath
country: Belgium
city: Bruxelles
country: Belgium
city: Dinant
country: Belgium
city: Gilly (Charleroi)
country: Belgium
city: Kortrijk
country: Belgium
city: Lier
country: Belgium
city: Mons
country: Belgium
city: Namur
country: Belgium
city: Roeselare
country: Belgium
city: Seraing
country: Belgium
city: Sijsele
country: Belgium
city: Turnhout
country: Belgium
city: Verviers
country: Belgium
city: Waremme
country: Belgium
city: Westmalle
country: Belgium
city: Luxembourg
country: Luxembourg
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.