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

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ClinicalTrials.gov Identifier: NCT01667458
Recruitment Status : Completed
First Posted : August 17, 2012
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 59 participants
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
Study Start Date : September 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Cohort



Primary Outcome Measures :
  1. 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 :
  1. Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue [ Time Frame: 16 months ]
  2. Disease Activity Score DAS28 [ Time Frame: 16 months ]
  3. Pain: Visual Analogue Scale VAS Pain [ Time Frame: 16 months ]
  4. Functional disability: Health Assessment Questionnaire HAQ [ Time Frame: 16 months ]
  5. Quality of sleep: VAS [ Time Frame: 16 months ]
  6. Anemia: Haemoglobin levels [ Time Frame: 16 months ]
  7. Depression: Beck Depression Inventory (BDI) questionnaire [ Time Frame: 16 months ]


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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

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

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 Posted: August 17, 2012    Key Record Dates
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