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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.
ClinicalTrials.gov Identifier: NCT01117480
Recruitment Status : Completed
First Posted : May 5, 2010
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Collaborator:
University Health Network, Toronto
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Tracking Information
First Submitted Date May 4, 2010
First Posted Date May 5, 2010
Results First Submitted Date December 11, 2015
Results First Posted Date February 24, 2016
Last Update Posted Date February 24, 2016
Study Start Date July 2005
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2016)
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.
Original Primary Outcome Measures
 (submitted: May 4, 2010)
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: Baseline ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 6 months ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 12 months ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 18 months ]
  • DAS-28 (Disease Activity Score 28) including ESR (Erythrocyte sedimentation rate) [ Time Frame: 24 months ]
Change History Complete list of historical versions of study NCT01117480 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 27, 2016)
  • 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.
  • 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.
Original Secondary Outcome Measures
 (submitted: May 4, 2010)
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: Baseline ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 6 months ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 12 months ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 18 months ]
  • Change in HAQ (Health Assessment Questionnaire) [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA
Official Title Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
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.
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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with moderate-to-severe rheumatoid arthritis
Condition Moderate-to-severe Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts Moderate-to-severe rheumatoid arthritis
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 23, 2015)
1013
Original Estimated Enrollment
 (submitted: May 4, 2010)
1000
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries Canada
 
Administrative Information
NCT Number NCT01117480
Other Study ID Numbers PMOS-CANA-04-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AbbVie ( AbbVie (prior sponsor, Abbott) )
Study Sponsor AbbVie (prior sponsor, Abbott)
Collaborators University Health Network, Toronto
Investigators
Study Director: Linda Assouline, PhD AbbVie Corporation
PRS Account AbbVie
Verification Date January 2016