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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Changes in treatment schedules (dosage reduction/interruption/discontinuation) for safety reasons
Time Frame: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings