Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Arthritis+6

+ Autoimmune Diseases

+ Connective Tissue Diseases

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: September 2011
See protocol details

Summary

Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01667458
Principal SponsorHoffmann-La Roche
Last updated: November 2, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

59 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ArthritisAutoimmune DiseasesConnective Tissue DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesSkin and Connective Tissue DiseasesArthritis, Rheumatoid

Criteria

5 inclusion criteria required to participate
Absence of evolutive tuberculosis (TB)
Adult patients, >= 18 years of age
Eligible for RoActemra/Actemra treatment in daily clinical practice
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
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5 exclusion criteria prevent from participating
Active, severe infections
Hypersensitivity to tocilizumab or any of the excipients
Participation in any other interventional study
Patients with major depression
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 18 locations

Aalst, BelgiumOpen in Google Maps

Assebroek, Belgium

Ath, Belgium

Brussels, Belgium
Completed18 Study Centers