Moderate-to-severe Rheumatoid Arthritis
Conditions
Keywords
Moderate Rheumatoid Arthritis, Rheumatoid Arthritis, Severe Rheumatoid Arthritis, Adalimumab, Clinical Effectiveness
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.
Interventions
None listed
Sponsors
University Health Network, Toronto
AbbVie (prior sponsor, Abbott)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | 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) | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Moderate-to-severe Rheumatoid Arthritis Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice | 985 |
| Total | 985 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did Not Start Adalimumab Therapy | 20 |
| Overall Study | Protocol Violation | 8 |
Baseline characteristics
| Characteristic | Moderate-to-severe Rheumatoid Arthritis |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 12.8 |
| Disease Activity Score 28 (DAS-28) | 5.14 units on a scale STANDARD_DEVIATION 1.6 |
| Disease duration | 10.0 years STANDARD_DEVIATION 9.8 |
| Health Assessment Questionnaire (HAQ) | 1.39 units on a scale STANDARD_DEVIATION 0.72 |
| Rheumatoid Arthritis Disease Activity Index (RADAI) | 5.4 units on a scale STANDARD_DEVIATION 2.1 |
| Sex: Female, Male Female | 751 Participants |
| Sex: Female, Male Male | 234 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 43 / 985 |
Outcome results
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.
Time frame: Month 0, 6, 12, 18 and 24
Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moderate-to-severe Rheumatoid Arthritis | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | Month 0 | 11 percentage of participants |
| Moderate-to-severe Rheumatoid Arthritis | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | Month 6 | 13 percentage of participants |
| Moderate-to-severe Rheumatoid Arthritis | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | Month 12 | 16 percentage of participants |
| Moderate-to-severe Rheumatoid Arthritis | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | Month 18 | 15 percentage of participants |
| Moderate-to-severe Rheumatoid Arthritis | Percentage of Participants That Achieved a Disease Activity Score 28 (DAS28) < 2.6 | Month 24 | 16 percentage of participants |
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.
Time frame: Month 0, 6, 12, 18 and 24
Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | Month 0 | 1.39 units on a scale | Standard Deviation 0.72 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | Month 6 | -0.31 units on a scale | Standard Deviation 0.56 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | Month 12 | -0.34 units on a scale | Standard Deviation 0.61 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | Month 18 | -0.37 units on a scale | Standard Deviation 0.63 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Health Assessment Questionnaire (HAQ) | Month 24 | -0.37 units on a scale | Standard Deviation 0.65 |
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.
Time frame: Month 0, 6, 12, 18 and 24
Population: Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | Month 0 | 5.4 units on a scale | Standard Deviation 2.1 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | Month 6 | -1.55 units on a scale | Standard Deviation 2.14 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | Month 12 | -1.77 units on a scale | Standard Deviation 2.3 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | Month 18 | -1.88 units on a scale | Standard Deviation 2.32 |
| Moderate-to-severe Rheumatoid Arthritis | Mean Change From Baseline (Month 0) in Rheumatoid Arthritis Disease Activity Index (RADAI) | Month 24 | -1.93 units on a scale | Standard Deviation 2.39 |