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The objective of this study was to assess the effectiveness of adalimumab on health and disability outcomes in participants with rheumatoid arthritis (RA) in China.
This was a prospective, multicenter, observational study to assess the effectiveness of adalimumab on health-related quality of life (QoL) and work productivity in participants with rheumatoid arthritis (RA) in routine clinical practice in China. The decision to prescribe adalimumab for RA was based on clinical practice criteria without taking participation in this study into account. Participants were included in the study after a physician's decision of initiating adalimumab treatment. Participants were followed for 24 weeks, with scheduled study visits at baseline, Week 12 and Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with RA receiving adalimumab | 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Biological | Pre-filled syringe, administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 | 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. A negative median indicates improvement from baseline. | Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12 | 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. A negative median indicates improvement from baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with rheumatoid arthritis (RA) in China receiving adalimumab treatment
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc. | AbbVie | Study Director |
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| Label | URL |
|---|---|
| Related Info | View source |
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All participants who received at least one dose of adalimumab during the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With RA Receiving Adalimumab | 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of adalimumab during the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With RA Receiving Adalimumab | 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
| 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 | Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 24 | 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. A negative median indicates improvement from baseline. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 24 |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 70 days after the last dose of study drug (up to 34 weeks).
TEAEs and SAEs are defined as any AE or SAE with onset or worsening reported by a participant from the time that the first dose of adalimumab is administered until 5 half-lives (70 days) have elapsed following discontinuation of adalimumab administration. TEAEs were collected whether elicited or spontaneously reported by the participant.
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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 | Participants With RA Receiving Adalimumab | 40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenitis | Blood and lymphatic system disorders | MedDRA 20.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 7, 2017 | May 31, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2019 | May 31, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Baseline and Week 12 |
| Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement. | Baseline, Week 12, and Week 24 |
| Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index | The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement. | Baseline, Week 12, and Week 24 |
| Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline. | Baseline, Week 12, and Week 24 |
| Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 * 100. Negative values indicate improvement from baseline. | Baseline, Week 12, and Week 24 |
| Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) 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. | Baseline, Week 12, and Week 24 |
| Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) 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. | Baseline, Week 12, and Week 24 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Medical insurance type | Count of Participants | Participants | No |
|
| Mean Baseline DAS28 score | The Disease Activity Score 28 (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, the erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP) level, and the participant's assessment of global disease activity (on a visual analog scale [VAS] from 0 to 10 cm) are included in the score. Scores range from 0 to 10; higher scores indicate more disease activity. A DAS28 score >5.1 indicates high disease activity, a score <3.2 indicates low disease activity, and a score <2.6 indicates clinical remission. | Mean | Standard Deviation | units on a scale |
|
| OG000 |
| Participants With RA Receiving Adalimumab |
40 mg adalimumab via subcutaneous (SC) injection every other week (eow) for 24 weeks |
|
|
|
| Secondary | Median Change From Baseline in Health Assessment Questionnaire- Disability Index (HAQ-DI) Score at Week 12 | 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. A negative median indicates improvement from baseline. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
|
|
|
| Secondary | Median Change From Baseline in Short Form 36-Item Health Survey (SF-36) Physical Component Summary (PCS) Score and Mental Component Summary (MCS) Scores at Weeks 12 and 24 | The SF-36v2 is a non-disease specific Health Related Quality of Life (HRQoL) instrument. The SF-36v2 comprises 36 total items (questions) targeting a subject's functional health and well-being in 8 domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health) with a recall period of four weeks. Domain scores are aggregated into a Physical Component Summary (PCS) score and a Mental Component Summary (MCS) score. SF-36v2 PCS and MCS scores range from 1-100: higher scores indicate a better state of health and an increase from baseline represents improvement. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Median Change From Baseline in EuroQol 5-dimension, 3-level Quality of Life Questionnaire (EQ-5D-3L) Index | The EQ-5D-3L measures the participant's overall health state in a descriptive system of health-related quality of life (QoL) states consisting of five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) each of which has three response choices. The responses record three levels of severity ('no problems', 'having some or moderate problems', and 'being unable to do/extreme problems') within a particular EQ-5D-3L dimension. In addition, a 20 cm visual analogue scale (VAS) measures the participant's self-rated current health state on a scale from 0-100, from 0 (worst imaginable health state) to 100 ('best imaginable health state). The EQ-5D-3L results were converted into a weighted health state index with scores ranging from approximately 0 (death) to 1 (full health). A positive change from baseline indicates improvement. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Median | Inter-Quartile Range | units on a scale | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Overall Work Impairment Score | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. The 'overall work impairment due to health problem' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days from visit; (Q4) the number of actual work hours in the past seven days from visit; and (Q5) to what degree did the participant's rheumatoid arthritis impair the productivity while working past seven days from visit). Data were calculated using the formula Q2/(Q2+Q4)+[(1-(Q2/(Q2+Q4))x(Q5/10)] and converted to percent, with higher numbers indicating greater impairment and less productivity. Negative values indicate improvement from baseline. | Observed population: participants continuing adalimumab treatment after the baseline visit who had at least Baseline data for this endpoint | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Median Change From Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI) Activity Impairment Score | The Work Productivity and Activity Impairment Questionnaire (WPAI) is a participant-reported questionnaire to measure work and activity impairment during the past seven days. Activity impairment was calculated via WPAI question 6, the participant's rating of how much rheumatoid arthritis affected their ability to do regular daily activities, other than working at a job (0 = no effect; 10 = completely impacted productivity) / 10 * 100. Negative values indicate improvement from baseline. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Median | Inter-Quartile Range | percent impairment | Baseline, Week 12, and Week 24 |
|
|
|
|
| Secondary | Number of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) 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. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Count of Participants | Participants | No | Baseline, Week 12, and Week 24 |
|
|
|
| Secondary | Percentage of Participants Achieving Clinically Meaningful Improvement in Health Assessment Questionnaire- Disability Index (HAQ-DI) 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. | Observed population: participants continuing adalimumab treatment after the baseline visit; participants with available data | Posted | Number | percentage of participants | Baseline, Week 12, and Week 24 |
|
|
|
| 0 |
| 55 |
| 2 |
| 55 |
| 17 |
| 55 |
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Enteritis | Gastrointestinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Injection site hypersensitivity | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 20.0 | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 20.0 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Eosinophil count increased | Investigations | MedDRA 20.0 | Systematic Assessment |
|
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 20.0 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 20.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.0 | Systematic Assessment |
|
| Neurodermatitis | Skin and subcutaneous tissue disorders | MedDRA 20.0 | 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
|
| PCS T-Score Week 24 |
|
|
| MCS T-Score Week 24 |
|
|
| =0.1233 |
| Other |
| Median change from baseline in PCS T-score at Week 24 | Wilcoxon signed-rank test | <0.001 | Other |
| Median change from baseline in MCS T-score at Week 24 | Wilcoxon signed-rank test | =0.001 | Other |
|
| <0.0001 |
| Other |
|
| =0.0607 |
| Other |
|
| =0.0001 |
| Other |
|
|