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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
  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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 59
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01667458


Locations
Belgium
Aalst, Belgium, 9300
Assebroek, Belgium, 8310
Ath, Belgium, 7800
Bruxelles, Belgium, 1000
Dinant, Belgium, 5500
Gilly (Charleroi), Belgium, 6000
Kortrijk, Belgium, 8500
Lier, Belgium, 2500
Mons, Belgium, 7000
Namur, Belgium, 5000
Roeselare, Belgium, 8800
Seraing, Belgium, 4100
Sijsele, 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01667458     History of Changes
Other Study ID Numbers: ML25702
First Submitted: August 15, 2012
First Posted: August 17, 2012
Last Update Posted: November 2, 2016
Last Verified: November 2016

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