Impact of AbbVie Care Patient Support Program on Clinical, Health Economic and Patient Reported Outcomes, in Crohn's Disease, Ulcerative Colitis, Rheumatoid Arthritis, Psoriatic Arthritis, Psoriasis and Axial Spondyloarthritis, in the Portuguese National Health Service (IMPROVE)

AbbVie

Status: Completed

Conditions: Psoriasis; Ankylosing Spondylitis (AS); Rheumatoid Arthritis (RA); Psoriatic Arthritis; Ulcerative Colitis (UC); Crohn's Disease; Non-radiographic Axial Spondyloarthritis

Study type: Observational

Funder types: Industry

Identifiers

NCT03223012

P16-321

Details and patient eligibility

About

This study aims to evaluate the impact of AbbVie Care 2.0 on adalimumab's compliance, patient reported outcomes and utilization of health resources over 12 months.

Enrollment: 116 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with crohn's disease (CD), ulcerative colitis (UC), rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (SpA) or psoriasis (Pso) according to the treating physician
• Adalimumab was started within 1 month prior to study enrollment
• Adalimumab was introduced based on current clinical practice criteria (i.e., the prescription of adalimumab was clearly separated from the decision to include the participants in this study)
• No prior record of adalimumab treatment
• Adalimumab was administered according to product label
• Naïve or previously experienced with biologic treatment
• Participant is able and willing to provide written authorization to disclose and use personal health information (informed consent), and to agree that data will be collected and provided to AbbVie

AbbVie Care 2.0 Cohort-specific inclusion criteria:

• Initiated the AbbVie care program within the first month after starting adalimumab.

Exclusion criteria

• Definitive discontinuation of adalimumab before being proposed to participate in the study
• Participated in any clinical experimental research within the 2 months prior to enrollment
• Pregnant or breastfeeding female participants
• Participant not able or not willing to comply with the requirements of this study protocol.

Trial design

116 participants in 2 patient groups

Participants not included in the AbbVie care program

Description:

Participants receiving adalimumab not included in the AbbVie care patient support program.

Participants included in the AbbVie care program

Description:

Participants receiving adalimumab included in the AbbVie care patient support program.