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: July 7, 2014
Last verified: July 2014
  Purpose

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.


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: July 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 July 26, 2014