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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Portugal
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 201322
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 201323
  • Braga, Portugal, 4710-243
    • CCA Braga - Hospital de Braga /ID# 201324
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, EPE /ID# 201335
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, EPE /ID# 201336
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar Lisboa Norte, EPE /ID# 201337
  • Lisbon, Portugal, 1150-069
    • Hospital Santo Antonio dos Cap /ID# 205700
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE /ID# 203535
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE /ID# 206278
  • Viseu, Portugal, 3504 - 509
    • Centro Hosp de Tondela-Viseu /ID# 203774
  • Viseu, Portugal, 3504 - 509
    • Centro Hosp de Tondela-Viseu /ID# 203775
  • Lisboa
    • Lisbon, Lisboa, Portugal, 1050-034
      • Instituto Portugues De Reumatologia /ID# 205963
    • Lisbon, Lisboa, Portugal, 1169-050
      • Centro Hosp de Lisboa Central /ID# 205698
    • Lisbon, Lisboa, Portugal, 1349-019
      • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328
    • Lisbon, Lisboa, Portugal, 1349-019
      • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants receiving adalimumab in routine clinical practice in Portugal

Description

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

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean number of injections administered/ prescribed for adalimumab	This is assessed based on patient diary.	Up to 12 months
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
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
Time Spent by the Patient to Refill Prescription	This is assessed by reviewing the work productivity indicator over 12 months.	Up to 12 months
Number of Hospital Inpatient Days	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Number of Emergency Visits	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Assessing Working Status	This is assessed by the proportion of patients employed.	Up to 12 months
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
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
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
Number of Complementary Exams/ Techniques	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
Number of Hospitalizations	This is assessed by reviewing the use of health resources over 12 months.	Up to 12 months
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2017
• Primary Completion (ACTUAL): February 28, 2019
• Study Completion (ACTUAL): February 28, 2019

Study Registration Dates

• First Submitted: July 18, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (ACTUAL): July 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): February 24, 2020
• Last Update Submitted That Met QC Criteria: February 20, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Psoriasis; Rheumatoid Arthritis; Ulcerative Colitis; Adalimumab; Humira®; Axial Spondyloarthritis; AbbVie patient care support program
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Skin Diseases; Infections; Immune System Diseases; Autoimmune Diseases; Gastrointestinal Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Inflammatory Bowel Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Ulcer; Arthritis; Arthritis, Rheumatoid; Psoriasis; Crohn Disease; Arthritis, Psoriatic; Colitis; Colitis, Ulcerative; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: P16-321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No