A Retrospective Observational Study on Compliance in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab) in Clinical Practice (REMISSION II)

November 1, 2016 updated by: Hoffmann-La Roche

Multicenter REtrospective Study to Evaluate coMpliance to Therapy and Drug survIval of Tocilizumab (TCZ) in patientS With Moderate to Severe actIve rheumatOid Arthritis in routiNe Daily Clinical Practice (REMISSION II Study)

This multicenter, retrospective observational study will evaluate compliance an reasons for withdrawal in patients with moderate to severe active rheumatoid arthritis on treatment with intravenous RoActemra/Actemra (tocilizumab) in daily clinical practice. Data will be collected from each eligible patient over a period of 6 months.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

183

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

  • Greece
      • Agia Paraskevi, Greece, 15342
      • Agios Dimitrios, Greece, 17343
      • Argiroupoli, Greece, 16452
      • Athens, Greece, 11521
      • Athens, Greece
      • Athens, Greece, 155 62
      • Athens, Greece, 11473
      • Chalandri, Greece
      • Chania, Greece, 73134
      • Eleusina, Greece, 19200
      • Herakleio, Greece, 71307
      • Ioannina, Greece, 455 00
      • Kifisia, Greece
      • Korinthos, Greece, 20100
      • Peristeri, Greece, 12934
      • Peuki, Greece, 15121
      • Rethymno, Greece, 74100
      • Serres, Greece, 62122
      • Thessaloniki, Greece, 54623
      • Thessaloniki, Greece
      • Thessaloniki, Greece, 54621
      • Thessaloniki, Greece, 54622
      • Thessaloniki, Greece, 54624
      • Volos, Greece, 38221

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

Rheumatoid arthritis patients suitable for treatment with RoActemra/Actemra according to SPC

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Moderate to severe rheumatoid arthritis according to the revised 1987 ACR criteria at baseline
  • RoActemra/Actemra treatment must have been initiated 6 months prior to ICF signing
  • Patient eligible according to the summary of product characteristics (SPC) and routine clinical practice/European recommendations for the use of biologic DMARDs for the treatment of rheumatoid arthritis

Exclusion Criteria:

  • Rheumatic autoimmune disease other than RA
  • Participation in interventional clinical trials during the observational period

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

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients on RoActemra/Actemra at 6 months after initiating treatment
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency of withdrawal (according to reasons)
Time Frame: 12 months
12 months
Frequency of dose modifications
Time Frame: 12 months
12 months
Change in disease activity (DAS28)
Time Frame: from baseline to Month 6 or withdrawal, whichever comes first
from baseline to Month 6 or withdrawal, whichever comes first

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

May 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 23, 2012

First Submitted That Met QC Criteria

July 23, 2012

First Posted (Estimate)

July 25, 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

  • ML28258

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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