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: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: September 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667458

Locations
Belgium
Aalst, Belgium, 9300
Assebroek, Belgium, 8310
ATH, Belgium, 7800
Bruxelles, Belgium, 1000
Dinant, Belgium, 5500
Kortrijk, Belgium, 8500
Lier, Belgium, 2500
Mons, Belgium, 7000
Montignies S/ Sambre, Belgium, 6061
Namur, Belgium, 5000
Roeselare, Belgium, 8800
Seraing, Belgium, 4100
Sijsele-Damme, Belgium, 8340
Turnhout, Belgium, 2300
Verviers, Belgium, 4800
Waremme, Belgium, 4300
Westmalle, Belgium, 2390
Luxembourg
Luxembourg, Luxembourg, 2763
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667458     History of Changes
Other Study ID Numbers: ML25702
Study First Received: August 15, 2012
Last Updated: April 7, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 23, 2014