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
Post-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
1 other identifier
observational
116
1 country
15
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 18, 2017
CompletedFirst Posted
Study publicly available on registry
July 19, 2017
CompletedStudy Start
First participant enrolled
November 15, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2019
CompletedFebruary 24, 2020
February 1, 2020
1.3 years
July 18, 2017
February 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with Medication Possession Ratio (MPR)>=80%
The variable MPR will be used, considering in the numerator the sum of days supply between start of observation (baseline) and last prescription dispensed (including the days of last prescription) and as denominator the number of days elapsed between baseline and last prescription dispensed (including the days of last prescription).
Up to 12 months
Secondary Outcomes (19)
Mean number of injections administered/ prescribed for adalimumab
Up to 12 months
Assessing Patient's overall satisfaction with AbbVie Care 2.0 program
At 12 months
Number of Sick Leaves
Up to 12 months
Time Spent by the Patient to Refill Prescription
Up to 12 months
Number of Hospital Inpatient Days
Up to 12 months
- +14 more secondary outcomes
Study Arms (2)
Participants not included in the AbbVie care program
Participants receiving adalimumab not included in the AbbVie care patient support program.
Participants included in the AbbVie care program
Participants receiving adalimumab included in the AbbVie care patient support program.
Eligibility Criteria
Participants receiving adalimumab in routine clinical practice in Portugal
You may qualify if:
- 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
- Initiated the AbbVie care program within the first month after starting adalimumab.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (15)
Instituto Portugues De Reumatologia /ID# 205963
Lisbon, Lisbon District, 1050-034, Portugal
Centro Hosp de Lisboa Central /ID# 205698
Lisbon, Lisbon District, 1169-050, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328
Lisbon, Lisbon District, 1349-019, Portugal
Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330
Lisbon, Lisbon District, 1349-019, Portugal
CCA Braga - Hospital de Braga /ID# 201322
Braga, 4710-243, Portugal
CCA Braga - Hospital de Braga /ID# 201323
Braga, 4710-243, Portugal
CCA Braga - Hospital de Braga /ID# 201324
Braga, 4710-243, Portugal
Hospital Santo Antonio dos Cap /ID# 205700
Lisbon, 1150-069, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201335
Lisbon, 1649-035, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201336
Lisbon, 1649-035, Portugal
Centro Hospitalar Lisboa Norte, EPE /ID# 201337
Lisbon, 1649-035, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 203535
Porto, 4200-319, Portugal
Centro Hospitalar de Sao Joao, EPE /ID# 206278
Porto, 4200-319, Portugal
Centro Hosp de Tondela-Viseu /ID# 203774
Viseu, 3504 - 509, Portugal
Centro Hosp de Tondela-Viseu /ID# 203775
Viseu, 3504 - 509, Portugal
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 18, 2017
First Posted
July 19, 2017
Study Start
November 15, 2017
Primary Completion
February 28, 2019
Study Completion
February 28, 2019
Last Updated
February 24, 2020
Record last verified: 2020-02