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This is a single-arm, multi-center, prospective cohort study (post-marketing observational study). The observation period for each participant is 48 weeks.
This study is designed to provide additional data on treatment effects of adalimumab during 48 weeks of treatment in patients with RA under conditions of routine rheumatology care. Course of work productivity and work ability, the course of health-related quality of life, and changes in functionality during 48 weeks treatment with adalimumab are to be documented.
This study was designed as a non-interventional observational study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab | Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) | Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48) |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) | Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA | The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) | DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity. |
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Inclusion Criteria:
RA patients treated with adalimumab who satisfied the following conditions:
Paid worker (PW) RA patients who are engaged in paid work for more than 35 hours per week
Home worker (HW)
Exclusion Criteria:
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Single-arm, Multi-center, Prospective Cohort
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| Name | Affiliation | Role |
|---|---|---|
| Sarina Kurimoto, MD | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | A Large-Scale Prospective Single Cohort Observational Study of Work Productivity and Activity Impairment In Japanese Patients With Rheumatoid Arthritis Receiving Adalimumab: The Final Analysis of 48-Week Data From the ANOUVEAU Study. EULAR2016 (9 June 2016), poster no. THU0159. | ||
| 28704126 | Result | Tanaka Y, Yamazaki K, Nakajima R, Komatsu S, Igarashi A, Tango T, Takeuchi T. Economic impact of adalimumab treatment in Japanese patients with rheumatoid arthritis from the adalimumab non-interventional trial for up-verified effects and utility (ANOUVEAU) study. Mod Rheumatol. 2018 Jan;28(1):39-47. doi: 10.1080/14397595.2017.1341459. Epub 2017 Jul 13. | |
| 28144917 |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 2088 participants filled out registration forms. A total of 1973 participant CRFs were retrieved for use in the study, and 1968 of these were included in the analysis.
Data sources in this study are from medical charts. Investigators in this study transcribed a participant's data from medical charts to a case report form (CRF) developed by AbbVie.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants Receiving Adalimumab | Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety Analysis Set (all evaluable participant CRFs)
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants Receiving Adalimumab | Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers). |
| 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 | Change From Baseline in Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA) Questionnaire: Mean Percentage of Work Time Missed (Absenteeism) | Absenteeism, presented as the mean percentage of work time missed due to RA (as reported on the WPAI-RA), and calculated as: 100*number of hours of work missed due to RA / (number of hours of work missed due to RA + number of hours worked). WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | percentage of work time missed | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of adalimumab (ADA) therapy, and at final assessment (up to Week 48) |
|
up to Week 52
Safety of adalimumab therapy was assessed using data obtained from the day of the first administration to 52 weeks after the initiation of adalimumab therapy. (Although adalimumab was administered for 48 weeks in this study, data during the 4 weeks after the end of Week 48 were also included into the analysis for participants for whom data after the treatment was described in their CRFs).
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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 Receiving Adalimumab | Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-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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| Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) |
| Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA | Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 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 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Number of Participants Per Category of the HAQ-DI | The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 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 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0). | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Number of Participants Per Category of the DAS28-4 CRP | DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6). | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Number of Participants Per Category of the DAS28-4 ESR | DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6). | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Change From Baseline in Clinical Disease Activity Index (CDAI) | The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Number of Participants Per Category of the CDAI | The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8). | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score | The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
| Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized. | up to Week 52 |
| Number of Participants With Adverse Drug Reactions | Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out. | up to Week 52 |
| Derived |
| Takeuchi T, Nakajima R, Komatsu S, Yamazaki K, Nakamura T, Agata N, Igarashi A, Tango T, Tanaka Y. Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study. Adv Ther. 2017 Mar;34(3):686-702. doi: 10.1007/s12325-017-0477-z. Epub 2017 Jan 31. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG000 |
| Participants Receiving Adalimumab |
Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers). |
|
|
|
| Primary | Change From Baseline in WPAI Questionnaire: Mean Percentage of Impairment While Working Due to RA (Presenteeism) | Presenteeism (the extent to which RA decreased productivity) is presented as the mean percentage of impairment while working due to RA, and calculated as: 100*scale value of question 5 on the WPAI (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | percentage of impairment while working | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) |
|
|
|
|
| Primary | Change From Baseline in WPAI Questionnaire: Mean Percentage of Overall Work Productivity Impairment (OWPI) Due to RA | The mean percentage of OWPI due to RA (based on the WPAI questionnaire) is presented, calculated as: Absenteeism (%) + extent to which RA decreased productivity (%)* [number of hours worked / (number of hours of work missed due to RA + number of hours worked)]. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | percentage of OWPI | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and at final assessment (up to Week 48) |
|
|
|
|
| Primary | Change From Baseline in WPAI Questionnaire: Mean Percentage of Activity Impairment Due to RA | Activity impairment due to RA (the extent to which RA affected the ability to perform usual daily activities) is presented as the mean percentage of activity impairment, calculated as 100*scale value of WPAI question 6 (between 0 and 10) / 10. WPAI is a questionnaire used to evaluate lost productivity; scores are presented as percentages (multiplying the scores by 100), with 0% representing no impact on productivity and 100% representing complete impact on productivity. "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable WPAI-RA assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | percentage of activity impairment | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Primary | Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score | The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 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 (no disability) to 3 (very severe, high-dependency disability). A negative change from Baseline in the score indicates improvement. | Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Primary | Number of Participants Per Category of the HAQ-DI | The HAQ-DI is a patient-reported questionnaire specific for RA. It consists of 20 questions referring to 8 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 (no disability) to 3 (very severe, high-dependency disability). Categories were defined as: high (> 1.5), moderate (≤ 1.5 to > 1.0), low (≤ 1.0 to > 0.5), remission (≤ 0.5 to > 0), 0 (0). | Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
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|
|
| Secondary | Change From Baseline in Disease Activity Score 28-4 C-Reactive Protein (DAS 28-4 CRP) | DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a visual analog scale (VAS). The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in score indicates improvement of disease activity. | Participants with evaluable HAQ-DI assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Secondary | Number of Participants Per Category of the DAS28-4 CRP | DAS28-4 CRP was calculated using the number of tender and swollen joints (out of 28 counted), CRP level, and the participant's global assessment of disease activity via a VAS. The calculated range of DAS28-4 is 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6). | Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
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|
| Secondary | Change From Baseline in DAS28-4 Erythrocyte Sedimentation Rate (ESR) | DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). A decrease from Baseline in scores indicates improvement of disease activity. | Participants with evaluable DAS28-4 ESR assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
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|
|
| Secondary | Number of Participants Per Category of the DAS28-4 ESR | DAS28-4 ESR, a combined index that measures activity of RA, was calculated based on the number of tender and swollen joints (out of 28 counted), general health evaluated by a VAS, and ESR. DAS28-4 ESR scores ranged from 0 (no disease activity) to 10 (maximal disease activity). Categories were defined as: high (> 5.1), moderate (≤ 5.1 to > 3.2), low (≤ 3.2 to ≥ 2.6), remission (< 2.6). | Participants with evaluable DAS28-4 CRP assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Secondary | Change From Baseline in Clinical Disease Activity Index (CDAI) | The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Secondary | Number of Participants Per Category of the CDAI | The CDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global health assessed by the participant on a VAS from 0 to 10 (cm), and global health assessed by an investigator on a visual analogue scale from 0 to 10 (cm) were included in the CDAI score. Scores on the CDAI range from 0 (lowest disease activity) to 76 (highest disease activity). Categories were defined as: high (> 22.1), moderate (≤ 22.0 to > 10.0), low (≤ 10.0 to < 2.8), and remission (≤ 2.8). | Participants with evaluable CDAI assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Count of Participants | Participants | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
|
|
|
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Questionnaire (EQ-5D) Summary Index Score | The EQ-5D is a participant answered questionnaire scoring 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. EQ-5D health states, defined by the EQ-5D descriptive system, are converted into a single summary index by applying a formula that essentially attaches values (also called QOL weights or QOL utilities) to each of the levels in each dimension. EQ-5D Summary Index values range from -0.594 to 1 (with higher scores indicating better health state). "Change" was calculated as the value at baseline minus the value at each subsequent time point. | Participants with evaluable EQ-5D assessments; number analyzed=participants with an evaluable assessment at given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 12, Week 24, Week 36, Week 48, at discontinuation of ADA therapy, and final assessment (up to Week 48) |
|
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| Secondary | Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), and Deaths | AEs, which were defined as any untoward medical occurrence observed in participants who received adalimumab in this study, were summarized. | Safety Analysis Set (all evaluable participants with validated CRFs) | Posted | Count of Participants | Participants | up to Week 52 |
|
|
|
| Secondary | Number of Participants With Adverse Drug Reactions | Adverse drug reactions were defined as AEs of which a causal relationship with adalimumab could not be ruled out. | Safety Analysis Set (all evaluable participants with validated CRFs) | Posted | Count of Participants | Participants | up to Week 52 |
|
|
|
| 103 |
| 1,968 |
| 202 |
| 1,968 |
| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningitis salmonella | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningitis viral | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia mycoplasmal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia pneumococcal | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Muscle abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bacterial sepsis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Urinary tract infection bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Staphylococcal infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Bursitis infective | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Infectious pleural effusion | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Haemangioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Meningioma malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Uterine cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Breast cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Metastatic carcinoma of the bladder | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Follicle centre lymphoma, follicular grade I, II, III | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Intraductal papillary mucinous neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Pleomorphic adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebellar infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cerebral infarction | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Uveitis | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vitreous haemorrhage | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Polypoidal choroidal vasculopathy | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hypoacusis | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Acute myocardial infarction | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Aortic aneurysm rupture | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rheumatoid vasculitis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hyperventilation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pulmonary infarction | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Organising pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Enterocolitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Dermatomyositis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Henoch-Schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Toxic skin eruption | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Lupus-like syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Death | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Spinal cord injury cervical | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Pelvic fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 18.1 | Non-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 |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | 0.0054 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| <0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | <0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | 0.0592 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| <0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | <0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | <0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Low |
|
| Remission |
|
| 0 |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| At discontinuation of ADA therapy |
|
|
| At final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy (Remission) | McNemar | = 0.0005 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Low |
|
| Remission |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| At ADA discontinuation |
|
|
| At final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at ADA discontinuation |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Low |
|
| Remission |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| At ADA discontinuation |
|
|
| At final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at discontinuation of ADA therapy |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Low |
|
| Remission |
|
| Week 12 |
|
|
| Week 24 |
|
|
| Week 36 |
|
|
| Week 48 |
|
|
| At ADA discontinuation |
|
|
| At final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment (Remission) | McNemar | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
|
| Change at Week 24 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
| Change at discontinuation of ADA therapy |
|
|
| Change at final assessment |
|
|
| < 0.0001 |
P-value adjusted for multiplicity |
| Superiority or Other |
| Week 36 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Week 48 | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at discontinuation of ADA therapy | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| at final assessment | Paired t-test | < 0.0001 | P-value adjusted for multiplicity | Superiority or Other |
| Title | Measurements |
|---|
|