A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

February 28, 2018 updated by: Hoffmann-La Roche

A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Study Overview

Status

Completed

Conditions

Rheumatoid Arthritis

Study Type

Observational

Enrollment (Anticipated)

100

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

Kuwait
- - Safat, Kuwait, 13041
Lebanon
- - Beirut, Lebanon, 99999
  - Beirut, Lebanon, 11-236
  - Beirut, Lebanon
  - Beirut, Lebanon, 470 Hazmieh
  - Beirut, Lebanon, 961
  - Jbeil, Lebanon, 1401
  - Saida, Lebanon, 652
  - Tripoli, Lebanon, 371 Tripoli
Qatar
- - Doha, Qatar, 3050
United Arab Emirates
- - Dubai, United Arab Emirates, P.O. Box 31500
  - Dubai, United Arab Emirates, P.O. Box 8179

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with moderate to severe rheumatoid arthritis and an inadequate response or intolerant to previous therapy with conventional DMARDs

Description

Inclusion Criteria:

Adult patients, >/= 21 years of age
Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2)
Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs)
Initiated on RoActemra/Actemra treatment in accordance with the prescribing information

Exclusion Criteria:

Pregnant or lactating women
Contra-indication to RoActemra/Actemra treatment according to the local labelling
Previous treatment with tocilizumab
Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
Women of childbearing potential not using effective methods of contraception as defined by protocol

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: Incidence of adverse events Time Frame: approximately 3 years	approximately 3 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) Time Frame: approximately 3 years	approximately 3 years
Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment Time Frame: approximately 3 years	approximately 3 years
Treatment regimens: Concomitant medications Time Frame: approximately 3 years	approximately 3 years

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 (Actual)

April 18, 2013

Primary Completion (Actual)

January 25, 2017

Study Completion (Actual)

January 25, 2017

Study Registration Dates

First Submitted

January 16, 2013

First Submitted That Met QC Criteria