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

This study has been completed.
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01117480
First received: May 4, 2010
Last updated: January 27, 2016
Last verified: January 2016
  Purpose
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
Moderate-to-severe Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 [ Time Frame: Month 0, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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:
  • Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) [ Time Frame: Month 0, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) [ Time Frame: Month 0, 6, 12, 18 and 24 ] [ Designated as safety issue: No ]
    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.


Enrollment: 1013
Study Start Date: July 2005
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Moderate-to-severe rheumatoid arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with moderate-to-severe rheumatoid arthritis
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01117480

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
University Health Network, Toronto
Investigators
Study Director: Linda Assouline, PhD AbbVie Corporation
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01117480     History of Changes
Other Study ID Numbers: PMOS-CANA-04-01 
Study First Received: May 4, 2010
Results First Received: December 11, 2015
Last Updated: January 27, 2016
Health Authority: Canada: Ethics Review Committee

Keywords provided by AbbVie:
Moderate Rheumatoid Arthritis
Rheumatoid Arthritis
Severe Rheumatoid Arthritis
Adalimumab
Clinical Effectiveness

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

ClinicalTrials.gov processed this record on December 08, 2016