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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01667458
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2012-08-15
• Study First Submitted QC: 2012-08-15
• Study First Posted: 2012-08-17
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Quality of sleep: VAS	16 months
Disease Activity Score DAS28	16 months
Pain: Visual Analogue Scale VAS Pain	16 months
Anemia: Haemoglobin levels	16 months
Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue	16 months
Functional disability: Health Assessment Questionnaire HAQ	16 months
Depression: Beck Depression Inventory (BDI) questionnaire	16 months