Rheumatoid Arthritis
Conditions
Keywords
Synovitis, Rheumatoid Arthritis
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
AbbVie (prior sponsor, Abbott)
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
A patient will be enrolled in this study if he/she fulfills ALL of the following criteria: * Male or Female patients ≥ 18 years of age with diagnosis of RA * Patient is eligible to start adalimumab therapy according to the local product label and prescription guidelines * Patient is naïve to all biologics e.g. anti-cluster of differentiation 4 (anti-CD4) and anti-TNF treatments at the start of the study * Patient has no history of inflammatory arthritis other than rheumatoid arthritis * Patient has no history of lymphoma or leukemia or other malignancies * Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines, Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations
Exclusion criteria
* Patients that are not diagnosed with rheumatoid arthritis as judged by the American College of Rheumatology criteria * Patient is currently diagnosed with any condition other than rheumatoid arthritis that may affect radiography progression * Susceptibility to infections including TB, as judged by the investigator * Patient is carrier of Hepatitis B virus * Patient is a pregnant or lactating female at the time of screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab. | Baseline (Visit 1) to 13 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percent Reduction in Ultrasonography Assessment Score | Baseline (Visit 1) to 13 weeks | 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. |
| Mean Number of Joints With Detected Erosions | Baseline (Visit 1) to 13 weeks | 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. |
| Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC) | Baseline (Visit 1) to 13 weeks | 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). |
| Mean Change in Health Assessment Questionnaire (HAQ) Score | Baseline (Visit 1) to 13 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rheumatoid Arthritis (RA) Participants Male or female participants at least 18 years of age with diagnosis of RA | 16 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Rheumatoid Arthritis (RA) Participants |
|---|---|
| Age, Continuous | 36.5 years STANDARD_DEVIATION 9.27 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 9 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 | 0 / 16 |
Outcome results
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.
Time frame: Baseline (Visit 1) to 13 weeks
Population: Participants with available data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis (RA) Participants | Mean Change in Synovitis Measured by B-modal Ultrasonography Assessment Score After 13 Weeks of Treatment With Adalimumab. | -9.6 units on a scale | Standard Deviation 4.98 |
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.
Time frame: Baseline (Visit 1) to 13 weeks
Population: Due to an error, HAQ data was not collected at 13 weeks. Therefore, only baseline data are reported.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Rheumatoid Arthritis (RA) Participants | Mean Change in Health Assessment Questionnaire (HAQ) Score | 1.19 units on a scale | Standard Deviation 0.65 |
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.
Time frame: Baseline (Visit 1) to 13 weeks
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) Participants | Mean Number of Joints With Detected Erosions | Visit 5, n=15 | 6.07 joints | Standard Deviation 2.91 |
| Rheumatoid Arthritis (RA) Participants | Mean Number of Joints With Detected Erosions | Visit 1, n=16 | 9.38 joints | Standard Deviation 1.89 |
| Rheumatoid Arthritis (RA) Participants | Mean Number of Joints With Detected Erosions | Visit 2, n=16 | 8.69 joints | Standard Deviation 2.5 |
| Rheumatoid Arthritis (RA) Participants | Mean Number of Joints With Detected Erosions | Visit 3, n=16 | 7.69 joints | Standard Deviation 3.3 |
| Rheumatoid Arthritis (RA) Participants | Mean Number of Joints With Detected Erosions | Visit 4, n=16 | 6.75 joints | Standard Deviation 3.24 |
p-value: 0.13Wilcoxon signed-rank test
p-value: 0.031Wilcoxon signed-rank test
p-value: 0.006Wilcoxon signed-rank test
p-value: 0.003Wilcoxon signed-rank test
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.
Time frame: Baseline (Visit 1) to 13 weeks
Population: Participants with available data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rheumatoid Arthritis (RA) Participants | Mean Percent Reduction in Ultrasonography Assessment Score | Visit 2, n=16 | -20.99 Percent reduction | Standard Deviation 18.4 |
| Rheumatoid Arthritis (RA) Participants | Mean Percent Reduction in Ultrasonography Assessment Score | Visit 3, n=16 | -35.60 Percent reduction | Standard Deviation 25.36 |
| Rheumatoid Arthritis (RA) Participants | Mean Percent Reduction in Ultrasonography Assessment Score | Visit 4, n=16 | -48.42 Percent reduction | Standard Deviation 19.88 |
| Rheumatoid Arthritis (RA) Participants | Mean Percent Reduction in Ultrasonography Assessment Score | Visit 5, n=15 | -56.91 Percent reduction | Standard Deviation 24.81 |
p-value: 0.001Wilcoxon signed-rank test
p-value: 0.001Wilcoxon signed-rank test
p-value: <0.001Wilcoxon signed-rank test
p-value: 0.001Wilcoxon signed-rank test
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).
Time frame: Baseline (Visit 1) to 13 weeks
Population: All enrolled participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rheumatoid Arthritis (RA) Participants | Percentage of Participants Who Achieved ≥ 20% Improvement in Both Tender Joint Count (TJC) and Swollen Joint Count (SJC) | 93.75 percentage of participants |