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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate-to-severe rheumatoid arthritis | Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants with moderate-to-severe rheumatoid arthritis
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| Name | Affiliation | Role |
|---|---|---|
| Linda Assouline, PhD | AbbVie Corporation | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Moderate-to-severe Rheumatoid Arthritis | Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline analyses accounts for Intention to treat (ITT) population (all participants who received at least 1 dose of study drug).
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| ID | Title | Description |
|---|---|---|
| BG000 | Moderate-to-severe Rheumatoid Arthritis | Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for DAS-28. | Posted | Number | percentage of participants | Month 0, 6, 12, 18 and 24 |
|
Serious adverse events were collected from the time the participant's informed consent was received until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment i.e., up to 10 weeks.
Non serious adverse events were not collected for this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moderate-to-severe Rheumatoid Arthritis | Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Month 0, 6, 12, 18 and 24 |
| 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 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Disease duration | Mean | Standard Deviation | years |
|
| Disease Activity Score 28 (DAS-28) | 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 total of 64 participants had DAS-28 information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis. | Mean | Standard Deviation | units on a scale |
|
| Health Assessment Questionnaire (HAQ) | HAQ-DI is a participant-reported questionnaire 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); which were summed and averaged to provide an overall score ranging from 0 to 3. A total of 13 participants had HAQ information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis. | Mean | Standard Deviation | units on a scale |
|
| Rheumatoid Arthritis Disease Activity Index (RADAI) | The RADAI is a questionnaire used for measuring disease activity. The index consists of 6 questions: (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 RADAI total score is the sum of individual items divided by 5 (range 0-10). A total of 13 participants had RADAI information missing/ unavailable at baseline. These participants were excluded from the efficacy analysis. | Mean | Standard Deviation | units on a scale |
|
Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
|
|
| 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. | Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for HAQ. | Posted | Mean | Standard Deviation | units on a scale | Month 0, 6, 12, 18 and 24 |
|
|
|
| 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. | Analyses included all participants who received at least 1 dose of adalimumab (ITT) with baseline data available for RADAI. | Posted | Mean | Standard Deviation | units on a scale | Month 0, 6, 12, 18 and 24 |
|
|
|
| 43 |
| 985 |
| 0 |
| 0 |
| Cardiac disorder | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastric ulcer perforation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Arthritis infective | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Escherichia urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Intestinal tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Arthritis bacterial | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Angiolipoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Bladder transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Colon cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Diffuse large B-cell lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Endometrial adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Invasive breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lentigo maligna | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Lung adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngeal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Small cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Neuropathy peripheral | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stevens-Johnson syndrome | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cholecystectomy | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Coronary artery bypass | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Eye operation | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Joint arthroplasty | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Knee operation | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngeal operation | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Spinal fusion surgery | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Title | Measurements |
|---|---|
|
| Month 18 |
|
| Month 24 |
|
| Title | Measurements |
|---|---|
|
| Month 18 |
|
| Month 24 |
|