Working... Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01117480
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
University Health Network, Toronto
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
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.

Condition or disease
Moderate-to-severe Rheumatoid Arthritis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1013 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
Study Start Date : July 2005
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with moderate-to-severe rheumatoid arthritis

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01117480

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
University Health Network, Toronto
Layout table for investigator information
Study Director: Linda Assouline, PhD AbbVie Corporation

Additional Information:
Layout table for additonal information
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01117480     History of Changes
Other Study ID Numbers: PMOS-CANA-04-01
First Posted: May 5, 2010    Key Record Dates
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016
Last Verified: January 2016

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Moderate Rheumatoid Arthritis
Rheumatoid Arthritis
Severe Rheumatoid Arthritis
Clinical Effectiveness

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases