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Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP) (PASSION)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01383421
First received: June 26, 2011
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Other
Official Title: A Post-Marketing Observational Study (PMOS) to Determine the Effectiveness and Patient Satisfaction With Adalimumab Treatment in Patients With Rheumatoid Arthritis (PASSION Study)

Resource links provided by NLM:


Further study details as provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):

Primary Outcome Measures:
  • Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78 [ Time Frame: Baseline, 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.


Secondary Outcome Measures:
  • Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12 [ Time Frame: Baseline, 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.

  • Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24 [ Time Frame: Baseline, 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.

  • Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36 [ Time Frame: Baseline, 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.

  • Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52 [ Time Frame: Baseline, 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.

  • Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64 [ Time Frame: Baseline, 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.


Other Outcome Measures:
  • Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78 [ Time Frame: Baseline and Weeks 24, 52, 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.

  • Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78 [ Time Frame: Baseline, 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.

  • Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78 [ Time Frame: Baseline, 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.

  • Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78 [ Time Frame: 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:

    • Patient's assessment of pain
    • Patient's global assessment of disease activity
    • Physician's global assessment of disease activity
    • HAQ-DI
    • Acute phase reactant value (CRP or erythrocyte sedimentation date [ESR])

  • Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78 [ Time Frame: 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.

    • A Good Response is defined as an improvement (decrease) in the DAS28 of > 1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
    • A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
    • No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1

  • Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78 [ Time Frame: 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.

    • A Good Response is defined as an improvement (decrease) in the DAS28 of >1.2 compared with Baseline and attainment of a DAS28 score of ≤ 3.2.
    • A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 from Baseline and attainment of a DAS28 score of ≤ 5.1; or, an improvement (decrease) in the DAS28 of > 1.2 from Baseline and attainment of a DAS28 score of > 3.2.
    • No Response is defined as either an improvement (decrease) in the DAS28 of ≤ 0.6, or an improvement (decrease) in the DAS28 of > 0.6 and ≤ 1.2 and attainment of a DAS28 of > 5.1

  • Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24 [ Time Frame: Baseline, 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.

  • Mean Change From Baseline in WPAI at Week 52 [ Time Frame: Baseline, 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.

  • Mean Change From Baseline in WPAI at Week 78 [ Time Frame: Baseline, 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.

  • Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24 [ Time Frame: Baseline, 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).

  • Mean Change From Baseline in TSQM Scores at Week 52 [ Time Frame: Baseline, 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).

  • Mean Change From Baseline in TSQM Scores at Week 78 [ Time Frame: Baseline, 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).

  • Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78 [ Time Frame: Baseline, Week 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).

  • 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 [ Time Frame: Baseline, 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.

  • Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13 [ Time Frame: Baseline, 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.

  • 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 [ Time Frame: Baseline, 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.

  • Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78 [ Time Frame: Baseline, 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.

  • PSP Satisfaction Questionnaire Responses at Week 12 [ Time Frame: 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.

  • PSP Satisfaction Questionnaire Responses at Week 24 [ Time Frame: 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.

  • PSP Satisfaction Questionnaire Responses at Week 52 [ Time Frame: 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.

  • PSP Satisfaction Questionnaire Responses at Week 78 [ Time Frame: 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.


Enrollment: 1036
Study Start Date: September 2011
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.


Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Representative disease population selected from rheumatology clinics in the countries selected.
Criteria

Inclusion Criteria:

  • Male or female aged at least 18 years that has been newly prescribed adalimumab therapy according to the local product label, with the first dose corresponding to the Enrollment/Baseline visit.
  • Patient with a diagnosis of moderate to severe RA, who has had insufficient response to one or more disease-modifying antirheumatic drugs (DMARDs), and has a prescription of adalimumab according to the local regulations.
  • Patients should be evaluated for tuberculosis (TB) exposure/risk factors for active and latent TB (per local requirements and according to the local product label).
  • Patients must be able and willing to provide written authorization to disclose and use personal health information (and informed consent where applicable) and comply with the requirements of this study protocol as well as agree to data being collected and provided to AbbVie.

Exclusion Criteria:

  • Patients should not be enrolled if they cannot be treated in accordance with the local adalimumab product label.
  • Patients treated with > 1 prior biologic DMARD for RA. Any prior treatment with adalimumab is prohibited.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01383421

Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Jasmina Kalabic, MD AbbVie
  More Information

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01383421     History of Changes
Other Study ID Numbers: P12-072
Study First Received: June 26, 2011
Results First Received: April 10, 2017
Last Updated: April 10, 2017

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Rheumatoid Arthritis
Patient Support Program
adalimumab

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on August 18, 2017