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This study is a non-confirmatory post-marketing observational study to explore and describe the effectiveness of adalimumab on rheumatoid arthritis (RA) treatment course and participant satisfaction over time in context with utilization of a patient support program (PSP). The core elements of the PSP were call centers (in and outbound)/hotlines, nursing services, starter packs, provision of educational materials (print and digital) regarding RA and adalimumab, and injection guides. Other elements of the PSP, which varied between countries, included (but were not limited to) refill reminders, email contacts, support groups, and newsletters.
The main objectives of the study are to examine the effectiveness of adalimumab treatment with respect to PSPs by means of Health Assessment Questionnaire Disability Index (HAQ-DI), Disease Activity Score (DAS28) results, and European League Against Rheumatism (EULAR) response criteria, as well as to evaluate the contribution of PSP to disease control, treatment continuation over time, participant's satisfaction, and PSP utilization.
The primary endpoint is the percentage of participants achieving a minimal clinically important difference (MCID) in HAQ-DI at Week 78. (MCID is improvement of at least 0.22 in HAQ-DI compared to Baseline). Secondary endpoints include the percentage of participants achieving MCID in HAQ-DI at Weeks 12, 24, 36, 52, 64 and other effectiveness parameters, including: changes in DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR 20/50/70 and EULAR moderate and good responses. Other secondary endpoints include health outcomes assessments including HAQ-DI, Work Productivity and Activity Impairment (WPAI), Compliance Questionnaire Rheumatology (CQR), and Treatment Satisfaction Questionnaire for Medication (TSQM) scores, expectation regarding PSP and health management via Patient Activation Measure (PAM-13), change in participant perceptions as measured by the Beliefs about Medicines Questionnaire (BMQ), and satisfaction with PSP as measured by PSP satisfaction assessment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With RA Receiving Adalimumab | Participants with RA who were prescribed adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated with ADA for their RA. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Baseline, Week 78 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity. |
Inclusion Criteria:
Exclusion Criteria:
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Representative disease population selected from rheumatology clinics in the countries selected.
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| Name | Affiliation | Role |
|---|---|---|
| Jasmina Kalabic, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28361468 | Derived | Van den Bosch F, Ostor AJK, Wassenberg S, Chen N, Wang C, Garg V, Kalabic J. Impact of Participation in the Adalimumab (Humira) Patient Support Program on Rheumatoid Arthritis Treatment Course: Results from the PASSION Study. Rheumatol Ther. 2017 Jun;4(1):85-96. doi: 10.1007/s40744-017-0061-7. Epub 2017 Mar 30. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With RA Receiving Adalimumab | Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated by ADA for their RA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT population: all enrolled participants who received at least 1 dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With RA Receiving Adalimumab | Participants with RA who initiated adalimumab based on current clinical practice criteria (without taking participation in the study into account), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated by ADA for their RA. |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Baseline, Week 78 |
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Baseline through Week 78 or early termination
All treatment-emergent serious adverse events (AEs), AEs leading to premature discontinuation from the study, and non-serious AEs of malignancy in patients 30 years of age and younger were collected and are presented. Spontaneously reported non-serious treatment-emergent AEs were also included.
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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 | Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. All participants were offered to participate in the PSP while treated with ADA for their RA. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HAEMORRHAGIC DISORDER | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NORMOCHROMIC NORMOCYTIC ANAEMIA | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor Abbott) | 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 |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Baseline, Week 24 |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Baseline, Week 36 |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Baseline, Week 52 |
| Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Baseline, Week 64 |
| Baseline and Weeks 24, 52, 78 |
| Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. | Baseline, Weeks 24, 52, and 78 |
| Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | 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 visual analogue scale 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 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. | Baseline, Weeks 24, 52, and 78 |
| Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:
| Week 78 |
| Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.
| Week 78 |
| Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.
| Week 78 |
| Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Baseline, Week 24 |
| Mean Change From Baseline in WPAI at Week 52 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Baseline, Week 52 |
| Mean Change From Baseline in WPAI at Week 78 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Baseline, Week 78 |
| Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Baseline, Week 24 |
| Mean Change From Baseline in TSQM Scores at Week 52 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Baseline, Week 52 |
| Mean Change From Baseline in TSQM Scores at Week 78 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Baseline, Week 78 |
| Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors "don't agree at all" (score = 1), "don't agree" (score = 2), "agree" (score = 3), and "agree very much" (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance). | Baseline, Week 24, 52, and 78 |
| Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Baseline, Week 78 |
| Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Baseline, Week 78 |
| Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Baseline, Week 78 |
| Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications. | Baseline, Week 78 |
| PSP Satisfaction Questionnaire Responses at Week 12 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Week 12 |
| PSP Satisfaction Questionnaire Responses at Week 24 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Week 24 |
| PSP Satisfaction Questionnaire Responses at Week 52 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Week 52 |
| PSP Satisfaction Questionnaire Responses at Week 78 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Week 78 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit.
These participants utilized the PSP that was offered.
| OG001 | Participants With RA Receiving Adalimumab: PSP Non-User | Participants with RA who initiated adalimumab based on current clinical practice criteria (regardless of participation in the study), with the first dose corresponding to the Enrollment/Baseline visit. These participants did not utilize the PSP that was offered. |
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| Secondary | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 12 |
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| Secondary | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 24 |
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| Secondary | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 36 |
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| Secondary | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 52 |
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| Secondary | Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 | The HAQ-DI is a self-reported assessment of how the participant's illness affects their ability to function in their daily life over the past week. The HAQ-DI for a participant is calculated as the mean of the following 8 category scores (range: 0 to 3): Dressing and Grooming, Rising, Eating, Walking, Hygiene, Reach, Grip, and Activities. A lower score demonstrates less disability. The MCID in HAQ-DI was defined as an improvement of at least 0.22 in HAQ-DI compared to Baseline. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 64 |
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| Other Pre-specified | Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 | The DAS28 is a validated combined index of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10, with higher numbers indicating more disease activity. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Weeks 24, 52, 78 |
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| Other Pre-specified | Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 | The SDAI is a validated measure of RA disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, global disease activity assessed by the participant on a visual analogue scale from 0 to 10 (cm) , global disease activity assessed by an investigator on a visual analogue scale from 0 to 10 (cm), and serum levels of C-reactive protein (mg/dL) were included in the SDAI score. Scores on the SDAI range from 0 to 86. An SDAI score ≥26.1 indicates high disease activity, an SDAI score between 11.1 and 26.0 indicates moderate disease activity, an SDAI score between 3.4 and 11.0 indicates low disease activity, and an SDAI score ≤3.3 indicates clinical remission. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 24, 52, and 78 |
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| Other Pre-specified | Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 | 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 visual analogue scale 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 to 76. A CDAI score ≥22.1 indicates high disease activity, a CDAI score between 10.1 and 22.0 indicates moderate disease activity, a CDAI score between 2.9 and 10.0 indicates low disease activity, and a CDAI score ≤2.8 indicates clinical remission. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Weeks 24, 52, and 78 |
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| Other Pre-specified | Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 | ACR20/50/70 response is a 20%/50%/70% improvement in a participant's disease condition compared to Baseline. A participant is considered an ACR20/50/70 responder if the following 3 criteria are met: ≥ 20/50/70% improvement in 28 tender joint count; ≥ 20/50/70% improvement in swollen joint count; ≥ 20/50/70% improvement in at least 3 of the following 5 assessments:
| Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases. | Posted | Number | percentage of participants | Week 78 |
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| Other Pre-specified | Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(ESR) score. The DAS28(ESR) score ranges from 0-10, with higher scores indicating more disease activity.
| Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases. | Posted | Number | percentage of participants | Week 78 |
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| Other Pre-specified | Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 | A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the DAS28(CRP) score. The DAS28(CRP) score ranges from 0-10, with higher scores indicating more disease activity.
| Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing visit values. Observed cases. | Posted | Number | percentage of participants | Week 78 |
|
|
|
| Other Pre-specified | Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in WPAI at Week 52 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in WPAI at Week 78 | The WPAI assessed impact of RA on work productivity and non-work activity limitation. Participants were asked during the past 7 days: how many hours did you miss from work because of problems associated with RA (absenteeism), how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your RA affect your productivity while you were working (overall work impairment), and much did RA affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "RA had no effect on this" and 10 indicating "RA completely prevented me from this." A decrease in the WPAI score indicates improvement. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 78 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in TSQM Scores at Week 52 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 52 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in TSQM Scores at Week 78 | TSQM is a 14-point measure to show that adherence is expected to be related with participants' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. TSQM responses are used to derive scores for scales measuring effectiveness, side effects, convenience, and global satisfaction (based on participant evaluation over the last 2 to 3 weeks, or since last medication use). Scores for each of the 4 scales range from 0 to 100 with higher scores indicating a better state or outcome (e.g., greater perceived effectiveness or satisfaction). | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 78 |
|
|
|
|
| Other Pre-specified | Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 | The CQR includes 19 items and measures RA treatment-specific compliance/adherence. Participants select an answer based on whether they agree with each statement. The agreements are based on a 4-point Likert scale with anchors "don't agree at all" (score = 1), "don't agree" (score = 2), "agree" (score = 3), and "agree very much" (score = 4). The total score is calculated by summing all 19 items and subtracting 19 from the total and dividing by 0.57. The compliance score ranges between 0 (complete non-compliance) to 100 (perfect compliance). | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment at given time point. Last observation carried forward. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 24, 52, and 78 |
|
|
|
|
| Other Pre-specified | Percentage of Participants Who Demonstrated Improvement From Baseline or Who Remained at Level 4 From Baseline on the Patient Activation Measure (PAM-13) at Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab. Non-responder imputation. | Posted | Number | percentage of participants | Baseline, Week 78 |
|
|
|
| Other Pre-specified | Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 4 at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Baseline, Week 78 |
|
|
|
| Other Pre-specified | Percentage of Participants Who Started at Level 3 (or Above) at Baseline and Remained at Level 3 or Improved to Level 4 on the PAM-13 at Week 78 | The PAM-13 is a measure used to assess the participant's knowledge, skill, and confidence for self-management of his/her health. Participants are given a questionnaire of 13 statements to which they responded that they strongly disagree (1), disagree (2), agree (3), or strongly agree (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4, with higher levels indicating more knowledge, skill and confidence for self-management. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and were at Level 3 or 4 at Baseline. Non-responder imputation. | Posted | Number | percentage of participants | Baseline, Week 78 |
|
|
|
| Other Pre-specified | Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 | The BMQ consists of 11 questions used to assess the participant's beliefs about medication and the necessity of medications prescribed to them for rheumatoid arthritis. Each question answered from 'strongly disagree' to 'strongly agree,' with some questions attributed to the necessity sub-scale, and others to the concern sub-scale. Each answer is scaled from 1 to 5. The necessity sub-scale is calculated by taking the average of necessity scores, and the concern sub-scale is calculated by taking the average of the concern scores. Higher scores on the necessity sub-scale represent the stronger perceptions of the participant for the necessity of their medication. Similarly, higher scores on the concerns sub-scale represent stronger concerns about the potential negative effects of their medications. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had non-missing Baseline and at least 1 non-missing post-Baseline value. Observed cases. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Week 78 |
|
|
|
|
| Other Pre-specified | PSP Satisfaction Questionnaire Responses at Week 12 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases. | Posted | Number | percentage of participants | Week 12 |
|
|
|
| Other Pre-specified | PSP Satisfaction Questionnaire Responses at Week 24 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases. | Posted | Number | percentage of participants | Week 24 |
|
|
|
| Other Pre-specified | PSP Satisfaction Questionnaire Responses at Week 52 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases. | Posted | Number | percentage of participants | Week 52 |
|
|
|
| Other Pre-specified | PSP Satisfaction Questionnaire Responses at Week 78 | The PSP satisfaction questionnaire evaluates the participant's satisfaction with specific PSP components as well as overall program satisfaction through the participant's selecting the response that best reflects their opinion: 1=very good; 2=good; 3=less satisfying; 4=I do not use the services. The percentage of participants at each response level per question is presented. | Intent to treat analysis population: all enrolled participants who received at least 1 dose of adalimumab and had an assessment. Observed cases. | Posted | Number | percentage of participants | Week 78 |
|
|
|
| 97 |
| 1,025 |
| 95 |
| 1,025 |
| ACUTE MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| ATRIAL FIBRILLATION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CARDIAC FAILURE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| CORONARY ARTERY STENOSIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| GOITRE | Endocrine disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULUM | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OESOPHAGEAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PROTEIN-LOSING GASTROENTEROPATHY | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RECTAL PROLAPSE | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE DAMAGE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MEDICAL DEVICE PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| NODULE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| BILE DUCT STONE | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHOLELITHIASIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEPATIC CIRRHOSIS | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS BACTERIAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHIOLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CHRONIC TONSILLITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE RELATED INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| DIVERTICULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| KIDNEY INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MENINGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| MYCOBACTERIUM MARINUM INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SALMONELLOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SALPINGO-OOPHORITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| SOFT TISSUE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UROSEPSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| VIRAL INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| WHIPPLE'S DISEASE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FEMUR FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| HUMERUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| PELVIC FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| THORACIC VERTEBRAL FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| UPPER LIMB FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| WOUND | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| OBESITY | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| TYPE 2 DIABETES MELLITUS | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| COMPARTMENT SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| COSTOCHONDRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| LUMBAR SPINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MONARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEOARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHEUMATOID NODULE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ROTATOR CUFF SYNDROME | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPINAL COLUMN STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPINAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SPONDYLOLISTHESIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDON DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| VERTEBRAL FORAMINAL STENOSIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ADENOCARCINOMA OF COLON | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| B-CELL LYMPHOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| BREAST CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LIPOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| LUNG ADENOCARCINOMA METASTATIC | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| METASTASES TO LIVER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| PROSTATE CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| THYROID NEOPLASM | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEMYELINATION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPOTONIA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ISCHAEMIC CEREBRAL INFARCTION | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| MAJOR DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| UTERINE PROLAPSE | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA EXERTIONAL | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| INTERSTITIAL LUNG DISEASE | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PLEURAL DISORDER | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PRODUCTIVE COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH PAPULAR | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| LEFT VENTRICULAR FAILURE | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| PALPITATIONS | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| TINNITUS | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| VERTIGO | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| VERTIGO POSITIONAL | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| BLEPHARITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| CATARACT | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| KERATITIS | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| VISION BLURRED | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL DISCOMFORT | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| GASTROINTESTINAL DISORDER | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ODYNOPHAGIA | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| ADVERSE DRUG REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHENIA | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEVICE MATERIAL ISSUE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE PAIN | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE RASH | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| INJECTION SITE REACTION | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| MALAISE | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERSENSITIVITY | Immune system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRITIS INFECTIVE | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| BRONCHOPULMONARY ASPERGILLOSIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| EYE INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GASTROENTERITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| GENITAL INFECTION FUNGAL | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HELICOBACTER INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| HERPES ZOSTER | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFECTION SUSCEPTIBILITY INCREASED | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PERIODONTITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| PYELONEPHRITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RASH PUSTULAR | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| RHINITIS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| TOOTH ABSCESS | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| WOUND INFECTION | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| FALL | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| BLOOD CHOLESTEROL INCREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| DRUG SPECIFIC ANTIBODY PRESENT | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| HYPERALBUMINAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERCHOLESTEROLAEMIA | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| ACQUIRED CLAW TOE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FOOT DEFORMITY | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| JOINT SWELLING | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCLE FATIGUE | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MUSCULAR WEAKNESS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RHEUMATOID ARTHRITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDON DISORDER | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| TENDONITIS | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| BENIGN NEOPLASM OF PROSTATE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| MELANOCYTIC NAEVUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| MIGRAINE | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| PINEAL GLAND CYST | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SCIATICA | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| SENSORY LOSS | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| DEPRESSION | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| IRRITABILITY | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| LOSS OF LIBIDO | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| SLEEP DISORDER | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| RENAL FAILURE | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DERMATITIS PSORIASIFORM | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| DRUG ERUPTION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ECZEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| PUSTULAR PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| RASH ERYTHEMATOUS | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| ROSACEA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| SKIN REACTION | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| FLUSHING | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HAEMORRHAGE | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HOT FLUSH | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| HYPERTENSION | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| PHLEBITIS | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| VASCULITIS | Vascular disorders | MedDRA 18.1 | 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 52 |
|
|
| Change at Week 78 |
|
|
Week 52 |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.006 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -0.260 |
| Standard Error of the Mean |
| 0.094 |
| 2-Sided |
| Superiority |
| Week 78 | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.018 | Statistical significance was set at P = 0.05. | LS Mean Difference | -0.233 | Standard Error of the Mean | 0.098 | 2-Sided | Superiority |
| Change at Week 52 |
|
|
| Change at Week 78 |
|
|
Week 52 |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.003 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -2.697 |
| Standard Error of the Mean |
| 0.903 |
| 2-Sided |
| Superiority |
| Week 78 | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.010 | Statistical significance was set at P = 0.05. | LS Mean Difference | -2.447 | Standard Error of the Mean | 0.945 | 2-Sided | Superiority |
| Change at Week 52 |
|
|
| Change at Week 78 |
|
|
Week 52 |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.002 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -2.549 |
| Standard Error of the Mean |
| 0.818 |
| 2-Sided |
| Superiority |
| Week 78 | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.002 | Statistical significance was set at P = 0.05. | LS Mean Difference | -2.734 | Standard Error of the Mean | 0.872 | 2-Sided | Superiority |
| ACR70 |
|
| No Response |
|
| None |
|
| WPAI presenteeism |
|
|
| WPAI overall work impairment |
|
|
| WPAI activity impairment |
|
|
WPAI presenteeism |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.736 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -0.824 |
| Standard Error of the Mean |
| 2.441 |
| 2-Sided |
| Superiority |
| WPAI overall work impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.700 | Statistical significance was set at P = 0.05. | LS Mean Difference | 1.207 | Standard Error of the Mean | 3.126 | 2-Sided | Superiority |
| WPAI activity impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.023 | Statistical significance was set at P = 0.05. | LS Mean Difference | -3.552 | Standard Error of the Mean | 1.561 | 2-Sided | Superiority |
| WPAI presenteeism |
|
|
| WPAI overall work impairment |
|
|
| WPAI activity impairment |
|
|
WPAI presenteeism |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.835 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -0.527 |
| Standard Error of the Mean |
| 2.523 |
| 2-Sided |
| Superiority |
| WPAI overall work impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.883 | Statistical significance was set at P = 0.05. | LS Mean Difference | -0.471 | Standard Error of the Mean | 3.205 | 2-Sided | Superiority |
| WPAI activity impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.019 | Statistical significance was set at P = 0.05. | LS Mean Difference | -3.792 | Standard Error of the Mean | 1.611 | 2-Sided | Superiority |
| WPAI presenteeism |
|
|
| WPAI overall work impairment |
|
|
| WPAI activity impairment |
|
|
WPAI presenteeism |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.753 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| -0.817 |
| Standard Error of the Mean |
| 2.598 |
| 2-Sided |
| Superiority |
| WPAI overall work impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.461 | Statistical significance was set at P = 0.05. | LS Mean Difference | -2.334 | Standard Error of the Mean | 3.159 | 2-Sided | Superiority |
| WPAI activity impairment | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | <0.001 | Statistical significance was set at P = 0.05. | LS Mean Difference | -5.537 | Standard Error of the Mean | 1.624 | 2-Sided | Superiority |
| TSQM effectiveness |
|
|
| TSQM global satisfaction |
|
|
| TSQM side effects |
|
|
TSQM effectiveness |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.164 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| 2.843 |
| Standard Error of the Mean |
| 2.042 |
| 2-Sided |
| Superiority |
| TSQM global satisfaction | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.003 | Statistical significance was set at P = 0.05. | LS Mean Difference | 5.473 | Standard Error of the Mean | 1.866 | 2-Sided | Superiority |
| TSQM side effects | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.335 | Statistical significance was set at P = 0.05. | LS Mean Difference | 1.705 | Standard Error of the Mean | 1.769 | 2-Sided | Superiority |
|
| TSQM global satisfaction |
|
| TSQM side effects |
|
TSQM effectiveness |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.106 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| 3.124 |
| Standard Error of the Mean |
| 1.930 |
| 2-Sided |
| Superiority |
| TSQM global satisfaction | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.002 | Statistical significance was set at P = 0.05. | LS Mean Difference | 5.572 | Standard Error of the Mean | 1.756 | 2-Sided | Superiority |
| TSQM side effects | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.269 | Statistical significance was set at P = 0.05. | LS Mean Difference | 1.885 | Standard Error of the Mean | 1.704 | 2-Sided | Superiority |
| TSQM effectiveness |
|
|
| TSQM global satisfaction |
|
|
| TSQM side effects |
|
|
TSQM effectiveness |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.011 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| 4.929 |
| Standard Error of the Mean |
| 1.929 |
| 2-Sided |
| Superiority |
| TSQM global satisfaction | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | <0.001 | Statistical significance was set at P = 0.05. | LS Mean Difference | 5.997 | Standard Error of the Mean | 1.775 | 2-Sided | Superiority |
| TSQM side effects | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.272 | Statistical significance was set at P = 0.05. | LS Mean Difference | 1.823 | Standard Error of the Mean | 1.657 | 2-Sided | Superiority |
| Change at Week 52 |
|
|
| Change at Week 78 |
|
|
Week 52 |
| ANCOVA |
LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. |
| 0.198 |
Statistical significance was set at P = 0.05. |
| LS Mean Difference |
| 0.772 |
| Standard Error of the Mean |
| 0.599 |
| 2-Sided |
| Superiority |
| Week 78 | ANCOVA | LS mean difference and P value are from ANCOVA model adjusting for corresponding Baseline values. | 0.131 | Statistical significance was set at P = 0.05. | LS Mean Difference | 0.884 | Standard Error of the Mean | 0.585 | 2-Sided | Superiority |
| Concern |
|
|
Concern |
| ANCOVA |
P value is from an ANCOVA model adjusting for Baseline. |
| 0.560 |
Statistical significance was set at P = 0.05. |
| LS Mean Between Group Change |
| 0.000 |
| Standard Error of the Mean |
| 0.0526 |
| 2-Sided |
| Superiority |
|
| Relieves my daily burden: score 3 |
|
|
| Relieves my daily burden: score 4 |
|
|
| Is always there for me: score 1 |
|
|
| Is always there for me: score 2 |
|
|
| Is always there for me: score 3 |
|
|
| Is always there for me: score 4 |
|
|
| Offers real added value service: score 1 |
|
|
| Offers real added value service: score 2 |
|
|
| Offers real added value service: score 3 |
|
|
| Offers real added value service: score 4 |
|
|
| Is exceptional: score 1 |
|
|
| Is exceptional: score 2 |
|
|
| Is exceptional: score 3 |
|
|
| Is exceptional: score 4 |
|
|
| PSP in total: score 1 |
|
|
| PSP in total: score 2 |
|
|
| PSP in total: score 3 |
|
|
| PSP in total: score 4 |
|
|
| Call center/hotline: score 1 |
|
|
| Call center/hotline: score 2 |
|
|
| Call center/hotline: score 3 |
|
|
| Call center/hotline: score 4 |
|
|
| Educational materials about life with RA: score 1 |
|
|
| Educational materials about life with RA: score 2 |
|
|
| Educational materials about life with RA: score 3 |
|
|
| Educational materials about life with RA: score 4 |
|
|
| Educational materials about adalimumab: score 1 |
|
|
| Educational materials about adalimumab: score 2 |
|
|
| Educational materials about adalimumab: score 3 |
|
|
| Educational materials about adalimumab: score 4 |
|
|
| Injection guide: score 1 |
|
|
| Injection guide: score 2 |
|
|
| Injection guide: score 3 |
|
|
| Injection guide: score 4 |
|
|
| Nursing services: score 1 |
|
|
| Nursing services: score 2 |
|
|
| Nursing services: score 3 |
|
|
| Nursing services: score 4 |
|
|
| Email contact: score 1 |
|
|
| Email contact: score 2 |
|
|
| Email contact: score 3 |
|
|
| Email contact: score 4 |
|
|
| Refill reminders: score 1 |
|
|
| Refill reminders: score 2 |
|
|
| Refill reminders: score 3 |
|
|
| Refill reminders: score 4 |
|
|
| Newsletters: score 1 |
|
|
| Newsletters: score 2 |
|
|
| Newsletters: score 3 |
|
|
| Newsletters: score 4 |
|
|
| Reimbursement support: score 1 |
|
|
| Reimbursement support: score 2 |
|
|
| Reimbursement support: score 3 |
|
|
| Reimbursement support: score 4 |
|
|
| Financial assistance: score 1 |
|
|
| Financial assistance: score 2 |
|
|
| Financial assistance: score 3 |
|
|
| Financial assistance: score 4 |
|
|
| Other educational materials: score 1 |
|
|
| Other educational materials: score 2 |
|
|
| Other educational materials: score 3 |
|
|
| Other educational materials: score 4 |
|
|
| Collection/disposal of sharps container: score 1 |
|
|
| Collection/disposal of sharps container: score 2 |
|
|
| Collection/disposal of sharps container: score 3 |
|
|
| Collection/disposal of sharps container: score 4 |
|
|
| Starter pack: score 1 |
|
|
| Starter pack: score 2 |
|
|
| Starter pack: score 3 |
|
|
| Starter pack: score 4 |
|
|
|
| Relieves my daily burden: score 3 |
|
|
| Relieves my daily burden: score 4 |
|
|
| Is always there for me: score 1 |
|
|
| Is always there for me: score 2 |
|
|
| Is always there for me: score 3 |
|
|
| Is always there for me: score 4 |
|
|
| Offers real added value service: score 1 |
|
|
| Offers real added value service: score 2 |
|
|
| Offers real added value service: score 3 |
|
|
| Offers real added value service: score 4 |
|
|
| Is exceptional: score 1 |
|
|
| Is exceptional: score 2 |
|
|
| Is exceptional: score 3 |
|
|
| Is exceptional: score 4 |
|
|
| PSP in total: score 1 |
|
|
| PSP in total: score 2 |
|
|
| PSP in total: score 3 |
|
|
| PSP in total: score 4 |
|
|
| Call center/hotline: score 1 |
|
|
| Call center/hotline: score 2 |
|
|
| Call center/hotline: score 3 |
|
|
| Call center/hotline: score 4 |
|
|
| Educational materials about life with RA: score 1 |
|
|
| Educational materials about life with RA: score 2 |
|
|
| Educational materials about life with RA: score 3 |
|
|
| Educational materials about life with RA: score 4 |
|
|
| Educational materials about adalimumab: score 1 |
|
|
| Educational materials about adalimumab: score 2 |
|
|
| Educational materials about adalimumab: score 3 |
|
|
| Educational materials about adalimumab: score 4 |
|
|
| Injection guide: score 1 |
|
|
| Injection guide: score 2 |
|
|
| Injection guide: score 3 |
|
|
| Injection guide: score 4 |
|
|
| Nursing services: score 1 |
|
|
| Nursing services: score 2 |
|
|
| Nursing services: score 3 |
|
|
| Nursing services: score 4 |
|
|
| Email contact: score 1 |
|
|
| Email contact: score 2 |
|
|
| Email contact: score 3 |
|
|
| Email contact: score 4 |
|
|
| Refill reminders: score 1 |
|
|
| Refill reminders: score 2 |
|
|
| Refill reminders: score 3 |
|
|
| Refill reminders: score 4 |
|
|
| Newsletters: score 1 |
|
|
| Newsletters: score 2 |
|
|
| Newsletters: score 3 |
|
|
| Newsletters: score 4 |
|
|
| Reimbursement support: score 1 |
|
|
| Reimbursement support: score 2 |
|
|
| Reimbursement support: score 3 |
|
|
| Reimbursement support: score 4 |
|
|
| Financial assistance: score 1 |
|
|
| Financial assistance: score 2 |
|
|
| Financial assistance: score 3 |
|
|
| Financial assistance: score 4 |
|
|
| Other educational materials: score 1 |
|
|
| Other educational materials: score 2 |
|
|
| Other educational materials: score 3 |
|
|
| Other educational materials: score 4 |
|
|
| Collection/disposal of sharps container: score 1 |
|
|
| Collection/disposal of sharps container: score 2 |
|
|
| Collection/disposal of sharps container: score 3 |
|
|
| Collection/disposal of sharps container: score 4 |
|
|
| Starter pack: score 1 |
|
|
| Starter pack: score 2 |
|
|
| Starter pack: score 3 |
|
|
| Starter pack: score 4 |
|
|
|
| Relieves my daily burden: score 3 |
|
|
| Relieves my daily burden: score 4 |
|
|
| Is always there for me: score 1 |
|
|
| Is always there for me: score 2 |
|
|
| Is always there for me: score 3 |
|
|
| Is always there for me: score 4 |
|
|
| Offers real added value service: score 1 |
|
|
| Offers real added value service: score 2 |
|
|
| Offers real added value service: score 3 |
|
|
| Offers real added value service: score 4 |
|
|
| Is exceptional: score 1 |
|
|
| Is exceptional: score 2 |
|
|
| Is exceptional: score 3 |
|
|
| Is exceptional: score 4 |
|
|
| PSP in total: score 1 |
|
|
| PSP in total: score 2 |
|
|
| PSP in total: score 3 |
|
|
| PSP in total: score 4 |
|
|
| Call center/hotline: score 1 |
|
|
| Call center/hotline: score 2 |
|
|
| Call center/hotline: score 3 |
|
|
| Call center/hotline: score 4 |
|
|
| Educational materials about life with RA: score 1 |
|
|
| Educational materials about life with RA: score 2 |
|
|
| Educational materials about life with RA: score 3 |
|
|
| Educational materials about life with RA: score 4 |
|
|
| Educational materials about adalimumab: score 1 |
|
|
| Educational materials about adalimumab: score 2 |
|
|
| Educational materials about adalimumab: score 3 |
|
|
| Educational materials about adalimumab: score 4 |
|
|
| Injection guide: score 1 |
|
|
| Injection guide: score 2 |
|
|
| Injection guide: score 3 |
|
|
| Injection guide: score 4 |
|
|
| Nursing services: score 1 |
|
|
| Nursing services: score 2 |
|
|
| Nursing services: score 3 |
|
|
| Nursing services: score 4 |
|
|
| Email contact: score 1 |
|
|
| Email contact: score 2 |
|
|
| Email contact: score 3 |
|
|
| Email contact: score 4 |
|
|
| Refill reminders: score 1 |
|
|
| Refill reminders: score 2 |
|
|
| Refill reminders: score 3 |
|
|
| Refill reminders: score 4 |
|
|
| Newsletters: score 1 |
|
|
| Newsletters: score 2 |
|
|
| Newsletters: score 3 |
|
|
| Newsletters: score 4 |
|
|
| Reimbursement support: score 1 |
|
|
| Reimbursement support: score 2 |
|
|
| Reimbursement support: score 3 |
|
|
| Reimbursement support: score 4 |
|
|
| Financial assistance: score 1 |
|
|
| Financial assistance: score 2 |
|
|
| Financial assistance: score 3 |
|
|
| Financial assistance: score 4 |
|
|
| Other educational materials: score 1 |
|
|
| Other educational materials: score 2 |
|
|
| Other educational materials: score 3 |
|
|
| Other educational materials: score 4 |
|
|
| Collection/disposal of sharps container: score 1 |
|
|
| Collection/disposal of sharps container: score 2 |
|
|
| Collection/disposal of sharps container: score 3 |
|
|
| Collection/disposal of sharps container: score 4 |
|
|
|
| Relieves my daily burden: score 3 |
|
|
| Relieves my daily burden: score 4 |
|
|
| Is always there for me: score 1 |
|
|
| Is always there for me: score 2 |
|
|
| Is always there for me: score 3 |
|
|
| Is always there for me: score 4 |
|
|
| Offers real added value service: score 1 |
|
|
| Offers real added value service: score 2 |
|
|
| Offers real added value service: score 3 |
|
|
| Offers real added value service: score 4 |
|
|
| Is exceptional: score 1 |
|
|
| Is exceptional: score 2 |
|
|
| Is exceptional: score 3 |
|
|
| Is exceptional: score 4 |
|
|
| PSP in total: score 1 |
|
|
| PSP in total: score 2 |
|
|
| PSP in total: score 3 |
|
|
| PSP in total: score 4 |
|
|
| Call center/hotline: score 1 |
|
|
| Call center/hotline: score 2 |
|
|
| Call center/hotline: score 3 |
|
|
| Call center/hotline: score 4 |
|
|
| Educational materials about life with RA: score 1 |
|
|
| Educational materials about life with RA: score 2 |
|
|
| Educational materials about life with RA: score 3 |
|
|
| Educational materials about life with RA: score 4 |
|
|
| Educational materials about adalimumab: score 1 |
|
|
| Educational materials about adalimumab: score 2 |
|
|
| Educational materials about adalimumab: score 3 |
|
|
| Educational materials about adalimumab: score 4 |
|
|
| Injection guide: score 1 |
|
|
| Injection guide: score 2 |
|
|
| Injection guide: score 3 |
|
|
| Injection guide: score 4 |
|
|
| Nursing services: score 1 |
|
|
| Nursing services: score 2 |
|
|
| Nursing services: score 3 |
|
|
| Nursing services: score 4 |
|
|
| Email contact: score 1 |
|
|
| Email contact: score 2 |
|
|
| Email contact: score 3 |
|
|
| Email contact: score 4 |
|
|
| Refill reminders: score 1 |
|
|
| Refill reminders: score 2 |
|
|
| Refill reminders: score 3 |
|
|
| Refill reminders: score 4 |
|
|
| Newsletters: score 1 |
|
|
| Newsletters: score 2 |
|
|
| Newsletters: score 3 |
|
|
| Newsletters: score 4 |
|
|
| Reimbursement support: score 1 |
|
|
| Reimbursement support: score 2 |
|
|
| Reimbursement support: score 3 |
|
|
| Reimbursement support: score 4 |
|
|
| Financial assistance: score 1 |
|
|
| Financial assistance: score 2 |
|
|
| Financial assistance: score 3 |
|
|
| Financial assistance: score 4 |
|
|
| Other educational materials: score 1 |
|
|
| Other educational materials: score 2 |
|
|
| Other educational materials: score 3 |
|
|
| Other educational materials: score 4 |
|
|
| Collection/disposal of sharps container: score 1 |
|
|
| Collection/disposal of sharps container: score 2 |
|
|
| Collection/disposal of sharps container: score 3 |
|
|
| Collection/disposal of sharps container: score 4 |
|
|