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Study stopped due to low enrollment
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This Post-Marketing Observational Study (PMOS) was conducted to assess the effectiveness of adalimumab on reducing synovitis (inflammation of the synovial membrane, which lines movable synovial joints, such as shoulders, elbows, wrists, knees, and hips) in adult participants with Rheumatoid Arthritis (RA) in Egypt. B-mode ultrasonography data was collected from participants receiving adalimumab treatment who had not been treated with any other anti-tumor necrosis factor (anti-TNF) therapy in the past.
This study was a prospective, observational, single arm, multicenter study. Participants were treated with adalimumab in accordance with usual clinical care practices and local marketing authorization requirements. A total of 5 visits were planned: Baseline (Visit 1), Visits 2, 3, 4 and 5 (Week 13). The time interval between the baseline visit and the second visit was approximately 2-3 weeks, with a window of one week. Additional study objectives were to investigate the rate of RA progression via changes in the B-mode ultrasonography assessment score over time as well as changes in the number of joints with erosion over time. The study was terminated due to low enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rheumatoid Arthritis (RA) participants | Male or female participants at least 18 years of age with diagnosis of RA |
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| Measure | Description | Time Frame |
|---|---|---|
| Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab. | Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36. | Baseline (Visit 1) to 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Percent Reduction in Ultrasonography Assessment Score | Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36. | Baseline (Visit 1) to 13 weeks |
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Inclusion Criteria:
A patient will be enrolled in this study if he/she fulfills ALL of the following criteria:
Exclusion Criteria:
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Private clinics
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| Name | Affiliation | Role |
|---|---|---|
| Iman Ibrahim | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rheumatoid Arthritis (RA) Participants | Male or female participants at least 18 years of age with diagnosis of RA |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Rheumatoid Arthritis (RA) Participants | Male or female participants at least 18 years of age with diagnosis of RA |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab. | Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle) on both left and right sides is the ultrasonography assessment score, with a score range of 0-36. | Participants with available data | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 1) to 13 weeks |
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Serious adverse events were collected from the time of informed consent until 30 days or 5 half-lives following the intake of the last dose of physician-prescribed treatment, up to 18 weeks.
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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 | Rheumatoid Arthritis (RA) Participants | Male or female participants at least 18 years of age with diagnosis of RA |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013585 | Synovitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| Mean Number of Joints With Detected Erosions | A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented. | Baseline (Visit 1) to 13 weeks |
| Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC) | The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC). | Baseline (Visit 1) to 13 weeks |
| Mean Change in Health Assessment Questionnaire (HAQ) Score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is 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. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks. | Baseline (Visit 1) to 13 weeks |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| Secondary | Mean Percent Reduction in Ultrasonography Assessment Score | Synovitis was scored on a scale of 0 to 3 (0=none, 1=minor, 2=moderate, and 3=major presence). The sum of the scores of all 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) is the ultrasonography assessment score, with a score range of 0-36. | Participants with available data | Posted | Mean | Standard Deviation | Percent reduction | Baseline (Visit 1) to 13 weeks |
|
|
|
|
| Secondary | Mean Number of Joints With Detected Erosions | A total of 12 joints (elbow, wrist, second metacarpal (MCP), third MCP, knee and ankle on both left and right sides) were assessed by ultrasonography at each study visit and the number of joints with erosion (wearing away) was documented. | Participants with available data | Posted | Mean | Standard Deviation | joints | Baseline (Visit 1) to 13 weeks |
|
|
|
|
| Secondary | Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC) | The American College of Rheumatology TJC and SJC was administered at each study visit. Participants were evaluated for tenderness and pain in 66 different joints when in motion (TJC), and 68 different joints were evaluated for swelling (SJC). | All enrolled participants | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline (Visit 1) to 13 weeks |
|
|
|
| Secondary | Mean Change in Health Assessment Questionnaire (HAQ) Score | The Health Assessment Questionnaire - Disability Index (HAQ-DI) is 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. The minimal clinically important difference (MCID) defined for the HAQ-DI is ≥0.22. HAQ remission indicating normal physical function is defined by HAQ-DI < 0.5. Negative mean changes from Baseline in the overall score indicate improvement. Due to an error, HAQ data was not collected at 13 weeks. | Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Visit 1) to 13 weeks |
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| 0 |
| 16 |
| 0 |
| 0 |
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 |
|---|---|
|
| Visit 5, n=15 |
|
| 0.001 |
Mean percent reduction in ultrasonography assessment score at Vist 3 as compared to Baseline (Visit 1) |
| 2-Sided |
| No |
| Superiority or Other |
| Wilcoxon signed-rank test | <0.001 | Mean percent reduction in ultrasonography assessment score at Vist 4 as compared to Baseline (Visit 1) | 2-Sided | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.001 | Mean percent reduction in ultrasonography assessment score at Vist 5 as compared to Baseline (Visit 1) | 2-Sided | No | Superiority or Other |
| Title | Measurements |
|---|---|
|
| Visit 4, n=16 |
|
| Visit 5, n=15 |
|
| 0.031 |
Mean number of joints with erosions at Vist 3 as compared to Baseline (Visit 1) |
| 2-Sided |
| No |
| Superiority or Other |
| Wilcoxon signed-rank test | 0.006 | Mean number of joints with erosions at Vist 4 as compared to Baseline (Visit 1) | 2-Sided | No | Superiority or Other |
| Wilcoxon signed-rank test | 0.003 | Mean number of joints with erosions at Vist 5 as compared to Baseline (Visit 1) | 2-Sided | No | Superiority or Other |