IMPROVEPost-marketing Prospective, Observational Cohort Study to Evaluate the Impact of AbbVie Care Patient Support Program on Compliance With Adalimumab, Patient Reported Outcomes and Health Resource Utilization in Inflammatory Bowel Diseases, Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis and Psoriasis in Portugal
Data Collection
Collected from today forward - ProspectiveAxial Spondyloarthritis+28
+ Non-Radiographic Axial Spondyloarthritis
+ Ankylosis
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: November 15, 2017
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.116 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 99 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 15 locations
Instituto Portugues De Reumatologia /ID# 205963
Lisbon, PortugalOpen Instituto Portugues De Reumatologia /ID# 205963 in Google MapsCentro Hosp de Lisboa Central /ID# 205698
Lisbon, PortugalCentro Hospitalar Lisboa Ocidental, EPE /ID# 201328
Lisbon, PortugalCentro Hospitalar Lisboa Ocidental, EPE /ID# 201330
Lisbon, Portugal