An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)
NCT ID: NCT01667458
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
59 participants
OBSERVATIONAL
2011-09-30
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Active, severe infections
* Pregnant or lactating women
* Participation in any other interventional study
* Patients with major depression
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Aalst, , Belgium
Assebroek, , Belgium
Ath, , Belgium
Brussels, , Belgium
Dinant, , Belgium
Gilly (Charleroi), , Belgium
Kortrijk, , Belgium
Lier, , Belgium
Mons, , Belgium
Namur, , Belgium
Roeselare, , Belgium
Seraing, , Belgium
Sijsele, , Belgium
Turnhout, , Belgium
Verviers, , Belgium
Waremme, , Belgium
Westmalle, , Belgium
Luxembourg, , Luxembourg
Countries
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References
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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.
Other Identifiers
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ML25702
Identifier Type: -
Identifier Source: org_study_id