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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667458
• Other study ID #: ML25702
• Status: Completed
• Phase: N/A
• First received: August 15, 2012
• Last updated: November 1, 2016
• Start date: September 2011
• Est. completion date: December 2012

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Fatigue
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Belgium,  Luxembourg, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16		16 months	No
Secondary	Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue		16 months	No
Secondary	Disease Activity Score DAS28		16 months	No
Secondary	Pain: Visual Analogue Scale VAS Pain		16 months	No
Secondary	Functional disability: Health Assessment Questionnaire HAQ		16 months	No
Secondary	Quality of sleep: VAS		16 months	No
Secondary	Anemia: Haemoglobin levels		16 months	No
Secondary	Depression: Beck Depression Inventory (BDI) questionnaire		16 months	No