Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

AbbVie

Status: Completed

Conditions: Psoriasis; Ulcerative Colitis; Psoriatic Arthritis; Crohn's Disease; Ankylosing Spondylitis; Rheumatoid Arthritis

Treatments: Behavioral: AbbVie Care 2.0; Biological: Adalimumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02750800

P15-673

Details and patient eligibility

About

The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.

Full description

This was a prospective, open label, multicenter, observational cohort study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. AbbVie offered an array of services as part of a patient support program, called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was to provide educational resources that aimed to help participants understand their health condition and disease management (e.g., lifestyle - exercise or diet), but also help to them understand how to administer the product safely and be empowered to stay on track with their prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.

Enrollment: 427 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) by the treating physician
• Age ≥ 18 years at the time of enrollment
• RA, AS, PsA, Ps, UC or CD patients for whom adalimumab treatment was indicated as per local Summary of Product Characteristics (SmPC) and professional/reimbursement guidelines
• Participants assigned to adalimumab treatment not more than 1 month prior to inclusion
• Participants to whom participation in AbbVie Care 2.0 Patient Support Program (PSP) program was offered and participant decided to join and had started the PSP
• Participants willing to be involved in the study and to sign patient informed consent form (ICF) and subject information form (SIF) in order to allow use and disclosure of his/her personal health information

Exclusion criteria

• Participants who could not be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines
• Participants treated with > 1 prior biologic disease modifying anti rheumatic drug (DMARD) for RA, AS, PsA, Ps, UC or CD
• Prior treatment with adalimumab for more than 1 month
• Participants currently participating in other clinical research studies
• Participants who were unwilling or unable to complete the quality of life and other patient-reported questionnaires

Trial design

427 participants in 1 patient group

Adalimumab and AbbVie Care 2.0

Description:

Adalimumab administered via subcutaneous (SC) injection for 12 months according to the approved EMA label and Hungarian financial protocols and supportive services via the AbbVie Care 2.0 patient support program

Treatment:

Behavioral: AbbVie Care 2.0

Biological: Adalimumab