Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

January 27, 2016 updated by: AbbVie (prior sponsor, Abbott)

Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

The purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab as used in routine clinical practice in adult participants with moderate to severe rheumatoid arthritis (RA) in Canada.

Study Overview

Status

Completed

Conditions

Detailed Description

REACH is an observational survey of participants with moderate to severe rheumatoid arthritis taking adalimumab. Participants who volunteer will be asked to provide information about their medical history and experiences with adalimumab. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry.

Study Type

Observational

Enrollment (Actual)

1013

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

Participants with moderate-to-severe rheumatoid arthritis

Description

Inclusion Criteria:

  • Participant is eligible to take part in the registry as per the product monograph.
  • Participants that are naïve to adalimumab therapy / or participants that have been receiving adalimumab therapy for less than 4 months.
  • Participant has moderately to severely active RA.
  • Participant who has had an inadequate response to one or more Disease Modifying Anti-Rheumatic Drugs (DMARDs).
  • Participant received provincial or private (insurance companies) approval for adalimumab.
  • Participant is able to give written informed consent and to understand the survey requirements.

Exclusion Criteria:

  • Participant to whom a traditional DMARD had never been tried.
  • Participant with a known hypersensitivity to adalimumab, or any of its components.
  • Participant is receiving free adalimumab as part of a compassionate program or an early access drug distribution program.
  • Participant with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes.
  • Participant with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the participant will not be available for a period of time (> 12 months) while being enrolled in the survey.

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
Moderate-to-severe rheumatoid arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
Time Frame: Month 0, 6, 12, 18 and 24
The DAS28 is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, erythrocyte sedimentation rate (ESR), and the Subject's Global Assessment of Disease Activity (subject rates disease activity using a likert scale from 0 [low activity] to 10 [high activity]) are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score >5.1 indicates high disease activity, a DAS28 score <3.2 indicates low disease activity, and a DAS28 score <2.6 indicates clinical remission.
Month 0, 6, 12, 18 and 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)
Time Frame: Month 0, 6, 12, 18 and 24
Physical function was evaluated using the Health Assessment Questionnaire - Disability Index (HAQ-DI), a participant-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
Month 0, 6, 12, 18 and 24
Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)
Time Frame: Month 0, 6, 12, 18 and 24
The RADAI is a questionnaire for participants used for measuring disease activity. The index consists of 6 questions. The items ask the participants about (1) global disease activity in the last 6 months, (2) disease activity in terms of current swollen and tender joints, (3) arthritis pain, (4) the current status of health, (5) duration of morning stiffness and (6) tender joints to be rated in a joint list. The joint list asks about pain in the left and right shoulders, elbows, wrists, fingers, hips, knees, ankles and toes. The first 3 items are all rated on a numeric rating scale from 0 to 10, where higher scores indicate more disease activity. The RADAI total score is the sum of individual items divided by 5 (range 0-10), with a higher score signifying more disease activity.
Month 0, 6, 12, 18 and 24

Collaborators and Investigators

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

Sponsor

AbbVie (prior sponsor, Abbott)

Collaborators

University Health Network, Toronto

Investigators

  • Study Director: Linda Assouline, PhD, AbbVie Corporation

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.

Helpful Links

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, 2005

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

February 24, 2016

Last Update Submitted That Met QC Criteria

January 27, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMOS-CANA-04-01

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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