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This study was prematurely terminated due to low enrollment
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A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.
This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC). Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients' disease activity measured by Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1 | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) | 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 general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission. |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Carlson | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 64782 | Guangzhou | 510080 | China | |||
| Site Reference ID/Investigator# 65702 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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Whole blood, serum
| Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Tender and Swollen Joint Counts | Change in number of tender joints and swollen joints for 28 assessed joints. | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in C-reactive Protein | C-reactive protein level in serum (mg/dL) | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation. | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Patient's Global Assessment of Disease Activity | A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly). | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Patient's Assessment of Pain | A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be). | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity | A horizontal VAS (100 mm) measure of the physician's global assessment of the participant's current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition). | Weeks 4, 8, 12, 26 |
| Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | The Health Assessment Questionnaire - Disability Index is a patient-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). | Weeks 4, 8, 12, 26 |
| Shanghai |
| 200052 |
| China |
| Site Reference ID/Investigator# 65706 | Ürümqi | 830001 | China |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| 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 | Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1 | Participants who received at least 6 consecutive injections of adalimumab (every other week) and have the necessary clinical data for both the Baseline and the Week 12 visit available. | Posted | Number | participants | Week 12 |
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| Secondary | Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR) | 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 general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score > 5.1 indicates high disease activity, ≤ 5.1 indicates moderate disease activity, ≤ 3.2 indicates low disease activity, and ≤ 2.6 indicates clinical remission. | Participants who received at least one injection of adalimumab and have the necessary clinical data available | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Tender and Swollen Joint Counts | Change in number of tender joints and swollen joints for 28 assessed joints. | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | Percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in C-reactive Protein | C-reactive protein level in serum (mg/dL) | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) | Rate at which red blood cells sediment in a period of 1 hour, a non-specific measure of inflammation; a higher rate = more inflammation. | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Patient's Global Assessment of Disease Activity | A horizontal Visual Analog Scale (VAS) (100 mm) measure of the participant's global assessment of RA disease activity, where the participant was asked to place a vertical mark on the line to indicate how well their RA has been within the last 24 hours, ranging from 0 mm (very well) to 100 mm (very poorly). | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Patient's Assessment of Pain | A horizontal VAS (100 mm) measure of the participant's assessment of RA pain, where the participant was asked to place a vertical mark on the line to indicate how much pain they have had due to RA in the past week, ranging from 0 mm (no pain) to 100 mm (pain as bad as it could be). | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity | A horizontal VAS (100 mm) measure of the physician's global assessment of the participant's current RA disease activity, ranging from 0 mm (very good condition) to 100 mm (very bad condition). | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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| Secondary | Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) | The Health Assessment Questionnaire - Disability Index is a patient-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). | Participants who received at least one injection of adalimumab and have the necessary clinical data available. | Posted | Mean | Standard Deviation | percent change | Weeks 4, 8, 12, 26 |
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From the time of signing of participant authorization or informed consent until 70 days following the last dose of study adalimumab.
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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 | Adalimumab | Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit. | 0 | 26 | 1 | 26 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
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The study was terminated early due to low enrollment and high drop-out rate. Only serious adverse events and events leading to discontinuation were collected.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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