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

AbbVie

Status: Completed

Conditions: Rheumatoid Arthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT01383421

P12-072

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,036 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,036 participants in 1 patient group

Participants With RA Receiving Adalimumab

Description:

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.