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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01667458
First received: August 15, 2012
Last updated: October 6, 2014
Last verified: October 2014

August 15, 2012
October 6, 2014
September 2011
January 2013   (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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • Disease Activity Score DAS28 [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Pain: Visual Analogue Scale VAS Pain [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Functional disability: Health Assessment Questionnaire HAQ [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Quality of sleep: VAS [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Anemia: Haemoglobin levels [ Time Frame: 16 months ] [ Designated as safety issue: No ]
  • Depression: Beck Depression Inventory (BDI) questionnaire [ Time Frame: 16 months ] [ Designated as safety issue: No ]
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 seve re rheumatoid arthritis who have an inadequate response to at least two DMARDs ( one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatm ent 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
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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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
January 2013
January 2013   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Luxembourg
 
NCT01667458
ML25702
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP