An Observational Study of Dosage Patterns in Routine Clinical Practice in Patients With Rheumatoid Arthritis (ACT-LIFE)

November 1, 2016 updated by: Hoffmann-La Roche

A Multi-centre Observational Study to Describe Usage and Dosification Patterns of RoActemra (Tocilizumab) Treatment in Rheumatoid Arthritis (RA) Patients in the Routine Clinical Practice. ACT-LIFE Study

This observational study will evaluate the dosage patterns, safety and efficacy of RoActemra/Actemra (tocilizumab) in clinical practice in patients with moderate to severe rheumatoid arthritis who have not responded or are intolerant to at least one disease-modifying antirheumatic drug (DMARD) or TNF inhibitor. Data will be collected from each patients for 12 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

400

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

  • Spain
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08907
      • Castellon, Spain, 12004
      • Cordoba, Spain, 14004
      • Girona, Spain, 17002
      • Granada, Spain, 18014
      • Granada, Spain, 18003
      • Huelva, Spain, 21005
      • Madrid, Spain, 28006
      • Madrid, Spain, 28046
      • Madrid, Spain, 28905
      • Madrid, Spain, 28041
      • Madrid, Spain, 28222
      • Madrid, Spain, 28935
      • Malaga, Spain, 29009
      • Murcia, Spain, 30008
      • Sevilla, Spain, 41009
      • Toledo, Spain, 45004
      • Valencia, Spain, 46017
      • Valencia, Spain, 46010
      • Valencia, Spain, 46015
    • Alicante
      • Elche, Alicante, Spain, 03203
      • Elda, Alicante, Spain, 03600
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
      • Sant Joan Despi, Barcelona, Spain, 08970
    • Cadiz
      • Jerez de La Frontera, Cadiz, Spain, 11407
    • Cantabria
      • Santander, Cantabria, Spain, 39008
      • Torrelavega, Cantabria, Spain, 39300
    • Castellon
      • Vinaroz, Castellon, Spain, 12500
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
    • La Coruña
      • La Coruna, La Coruña, Spain, 15006
      • Santiago de Compostela, La Coruña, Spain, 15706
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
      • Alcorcon, Madrid, Spain, 28922
      • San Lorenzo De El Escorial, Madrid, Spain, 28200
    • Murcia
      • Cartagena, Murcia, Spain, 30203
      • El Palmar, Murcia, Spain, 30120
      • Lorca, Murcia, Spain, 30800
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Orense
      • Ourense, Orense, Spain, 32005
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36204
    • Valencia
      • Alzira, Valencia, Spain, 46600
      • San Juan, Valencia, Spain, 03550
      • Valenica, Valencia, Spain, 46009
    • Vizcaya
      • Barakaldo, Vizcaya, Spain, 48903
      • Bilbao, Vizcaya, Spain, 48013
  • United States
    • Florida
      • Coral Springs, Florida, United States, 29010

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 rheumatoid arthritis initiated on treatment with RoActemra/Actemra after at least one previous DMARD or TNF-inhibitor treatment

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis (RA) of at least 6 months duration
  • Non-responder or intolerant to at least one DMARD or TNF inhibitor treatment
  • Initiated on treatment with RoActemra according to Summary of Product Characteristics (SPC) indications

Exclusion Criteria:

  • History of autoimmune disease or of any joint inflammatory disease other than RA
  • Pregnant or lactating women
  • Patients who have started RoActemra treatment in a clinical trial or for compassionate use
  • Treatment with any investigational drug in the previous 4 weeks (or at least 5 times the half-life of the drug)

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
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety: Incidence of adverse events
Time Frame: 12 months
12 months
Change in disease activity (disease activity score DAS28/ simple disease activity index SDAI)
Time Frame: 12 months
12 months
Response rate according to EULAR (European League Against Rheumatism) criteria
Time Frame: 12 months
12 months
Quality of life (Visual Analogue Scales, Health Assessment Questionnaire)
Time Frame: 12 months
12 months
Response/tolerance with regard to pretreatment with either DMARDs or TNF inhibitors
Time Frame: 12 months
12 months
Effect on DMARD tolerance/dosage in combination therapy
Time Frame: 12 months
12 months
Dosages used in clinical practice
Time Frame: 12 months
12 months

Collaborators and Investigators

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

Sponsor

Hoffmann-La Roche

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

July 1, 2010

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

April 18, 2011

First Submitted That Met QC Criteria

April 18, 2011

First Posted (Estimate)

April 19, 2011

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

  • ML25264

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.

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