Moderate-to-severe Rheumatoid Arthritis Clinical Trial
— REACHOfficial title:
Real Life Evaluation of Rheumatoid Arthritis in Canadians Taking HUMIRA (REACH)
| Verified date | January 2016 |
| Source | AbbVie |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Ethics Review Committee |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1013 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie (prior sponsor, Abbott) | University Health Network, Toronto |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | 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 | No |
| Secondary | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | 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 | No |
| Secondary | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | 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 | No |