Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Moderate-to-severe Rheumatoid Arthritis
- Sponsor
- AbbVie (prior sponsor, Abbott)
- Enrollment
- 1013
- Primary Endpoint
- Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
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 Outcomes
- Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ)(Month 0, 6, 12, 18 and 24)
- Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI)(Month 0, 6, 12, 18 and 24)