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

Psoriasis Clinical Trial

— IMPROVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03223012
• Other study ID #: P16-321
• Status: Completed
• Start date: November 15, 2017
• Est. completion date: February 28, 2019

Study information

• Verified date: February 2020
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ankylosing Spondylitis (AS)
• Arthritis
• Arthritis, Psoriatic
• Arthritis, Rheumatoid
• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Crohn's Disease
• Non-radiographic Axial Spondyloarthritis
• Psoriasis
• Psoriatic Arthritis
• Rheumatoid Arthritis (RA)
• Spondylarthritis
• Spondylitis
• Spondylitis, Ankylosing
• Ulcer
• Ulcerative Colitis (UC)

Locations

Country	Name	City	State
Portugal	CCA Braga - Hospital de Braga /ID# 201322	Braga
Portugal	CCA Braga - Hospital de Braga /ID# 201323	Braga
Portugal	CCA Braga - Hospital de Braga /ID# 201324	Braga
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 201335	Lisboa
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 201336	Lisboa
Portugal	Centro Hospitalar Lisboa Norte, EPE /ID# 201337	Lisboa
Portugal	Centro Hosp de Lisboa Central /ID# 205698	Lisbon	Lisboa
Portugal	Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328	Lisbon	Lisboa
Portugal	Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330	Lisbon	Lisboa
Portugal	Hospital Santo Antonio dos Cap /ID# 205700	Lisbon
Portugal	Instituto Portugues De Reumatologia /ID# 205963	Lisbon	Lisboa
Portugal	Centro Hospitalar de Sao Joao, EPE /ID# 203535	Porto
Portugal	Centro Hospitalar de Sao Joao, EPE /ID# 206278	Porto
Portugal	Centro Hosp de Tondela-Viseu /ID# 203774	Viseu
Portugal	Centro Hosp de Tondela-Viseu /ID# 203775	Viseu

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean number of injections administered/ prescribed for adalimumab	This is assessed based on patient diary.	Up to 12 months
Secondary	Assessing Patient's overall satisfaction with AbbVie Care 2.0 program	Patient's overall satisfaction with AbbVie Care 2.0 program is scored at 1: Very good, 2: Good and 3: Less satisfying.	At 12 months
Secondary	Number of Sick Leaves	This is assessed by reviewing work time lost due to other reasons than health problems during previous last seven days.	Up to 12 months
Secondary	Time Spent by the Patient to Refill Prescription	This is assessed by reviewing the work productivity indicator over 12 months.	Up to 12 months
Secondary	Number of Hospital Inpatient Days	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Number of Emergency Visits	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Assessing Working Status	This is assessed by the proportion of patients employed.	Up to 12 months
Secondary	Proportion of patients with 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).	At Month 6
Secondary	Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II	This 14-point measure attempts to show that adherence is expected to be related with patients' satisfaction with therapy and such satisfaction can be a function of not only the effect of the treatment, but also the services offered. Domains include: Effectiveness, Side effects, Convenience and Global satisfaction.	Up to Month 12
Secondary	Mean Change in EuroQoL (EQ-5D) score	EQ-5D considers five attributes of quality of life evaluation, i.e., mobility, self-care, usual activity, pain/ discomfort, and anxiety/ depression.	From Month 0 to Month 12
Secondary	Number of Complementary Exams/ Techniques	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Number of Hospitalizations	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Time Spent by the Health Care Providers (HCPs) During Medical Appointments	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Mean Change in Patient Activation Measure (PAM-13)	This is a powerful and reliable measure of patient activation. It is 13-item measure used to assess the patient knowledge, skill, and confidence for self-management.	From Month 0 to Month 12
Secondary	Mean Change in Beliefs about Medication Questionnaire (BMQ)	The BMQ comprises two sections: the BMQ-Specific, which assesses representations of medication prescribed for personal use and the BMQ-General, which assesses beliefs about medicines in general. This questionnaire is validated for use in Portugal.	From Month 0 to Month 12
Secondary	Change in Work Productivity and Activity Impairment- General Health (WPAI-GH)	WPA-GH assesses the impact of general health problem on work productivity and daily activities during the previous 7 days.	From Month 0 to Month 12
Secondary	Number of Outpatient Visits (in-office and remote) in Hospital Setting	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Secondary	Number of Days of Sick Leaves	This is assessed by reviewing work time lost due to health problems during previous seven days.	Up to 12 months
Secondary	Proportion of patients who are still on adalimumab after 6 and 12 months	This is used to assess persistence and it could be done using pharmacy refills.	Up to 12 months

External Links

•   clinical study report synopsis