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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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 Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
16 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

August 15, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 17, 2012

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25702

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Nigeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe