Clinical trial NCT01383421: Observational Study to Explore the Effectiveness of Adalimumab Treatment in Conjunction With Utilization of a Patient Support Program (PSP)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Patient Support Program
adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-06-28
Enrollment: 1036
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative disease population selected from rheumatology clinics in the countries selected.

Brief summary: 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.

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 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.

Primary outcomes:
measure: Percentage of Participants Achieving a Minimal Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 78
timeFrame: Baseline, Week 78
Secondary outcomes:
measure: Percentage of Participants Achieving a MCID in the HAQ-DI at Week 12
timeFrame: Baseline, Week 12
measure: Percentage of Participants Achieving a MCID in the HAQ-DI at Week 24
timeFrame: Baseline, Week 24
measure: Percentage of Participants Achieving a MCID in the HAQ-DI at Week 36
timeFrame: Baseline, Week 36
measure: Percentage of Participants Achieving a MCID in the HAQ-DI at Week 52
timeFrame: Baseline, Week 52
measure: Percentage of Participants Achieving a MCID in the HAQ-DI at Week 64
timeFrame: Baseline, Week 64
Other outcomes:
measure: Mean Change From Baseline in With 28-Joint Disease Activity Score of C-reactive Protein (DAS28[CRP]) at Weeks 24, 52, and 78
timeFrame: Baseline and Weeks 24, 52, 78
measure: Mean Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 24, 52, and 78
timeFrame: Baseline, Weeks 24, 52, and 78
measure: Mean Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 24, 52, and 78
timeFrame: Baseline, Weeks 24, 52, and 78
measure: Percentage of Participants Achieving American College of Rheumatology 20%, 50%, 70% (ACR20, ACR50, ACR70) Response at Week 78
timeFrame: Week 78
measure: Percentage of Participants With a Good or Moderate European League Against Rheumatism (EULAR) Response (Using DAS28[ESR] at Week 78
timeFrame: Week 78
measure: Percentage of Participants With a Good or Moderate EULAR Response (Using DAS28[CRP] at Week 78
timeFrame: Week 78
measure: Mean Change From Baseline in Work Productivity and Activity Impairment (WPAI) at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in WPAI at Week 52
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in WPAI at Week 78
timeFrame: Baseline, Week 78
measure: Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medication (TSQM) Scores at Week 24
timeFrame: Baseline, Week 24
measure: Mean Change From Baseline in TSQM Scores at Week 52
timeFrame: Baseline, Week 52
measure: Mean Change From Baseline in TSQM Scores at Week 78
timeFrame: Baseline, Week 78
measure: Mean Change From Baseline in Compliance Questionnaire Rheumatology (CQR) at Weeks 24, 52, and 78
timeFrame: Baseline, Week 24, 52, and 78
measure: 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
timeFrame: Baseline, Week 78
measure: Percentage of Participants Who Started and Remained at Level 4 From Baseline to Week 78 on the PAM-13
timeFrame: Baseline, Week 78
measure: 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
timeFrame: Baseline, Week 78
measure: Change From Baseline Means in the Beliefs About Medicines Questionnaire (BMQ) at Week 78
timeFrame: Baseline, Week 78
measure: PSP Satisfaction Questionnaire Responses at Week 12
timeFrame: Week 12
measure: PSP Satisfaction Questionnaire Responses at Week 24
timeFrame: Week 24
measure: PSP Satisfaction Questionnaire Responses at Week 52
timeFrame: Week 52
measure: PSP Satisfaction Questionnaire Responses at Week 78
timeFrame: Week 78
Locations:
Study officials:
affiliation: AbbVie
name: Jasmina Kalabic, MD
role: STUDY_DIRECTOR
References:
citation: 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.