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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01667458
First Posted: August 17, 2012
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
August 15, 2012
August 17, 2012
November 2, 2016
September 2011
December 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01667458 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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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
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
Rheumatoid Arthritis
Not Provided
Cohort
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
December 2012
December 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Luxembourg
 
 
NCT01667458
ML25702
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016