Clinical trial NCT03223012: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Ulcerative Colitis (UC)
Rheumatoid Arthritis (RA)
Psoriatic Arthritis
Psoriasis
Ankylosing Spondylitis (AS)
Non-radiographic Axial Spondyloarthritis
Keywords: Adalimumab
Humira®
AbbVie patient care support program
Psoriasis
Axial Spondyloarthritis
Rheumatoid Arthritis
Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2017-07-19
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving adalimumab in routine clinical practice in Portugal

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of patients with Medication Possession Ratio (MPR)>=80%
timeFrame: Up to 12 months
Secondary outcomes:
measure: Mean number of injections administered/ prescribed for adalimumab
timeFrame: Up to 12 months
measure: Assessing Patient's overall satisfaction with AbbVie Care 2.0 program
timeFrame: At 12 months
measure: Number of Sick Leaves
timeFrame: Up to 12 months
measure: Time Spent by the Patient to Refill Prescription
timeFrame: Up to 12 months
measure: Number of Hospital Inpatient Days
timeFrame: Up to 12 months
measure: Number of Emergency Visits
timeFrame: Up to 12 months
measure: Assessing Working Status
timeFrame: Up to 12 months
measure: Proportion of patients with MPR>=80%
timeFrame: At Month 6
measure: Mean score of Treatment Satisfaction Questionnaire for Medication (TSQM)-II
timeFrame: Up to Month 12
measure: Mean Change in EuroQoL (EQ-5D) score
timeFrame: From Month 0 to Month 12
measure: Number of Complementary Exams/ Techniques
timeFrame: Up to 12 months
measure: Number of Hospitalizations
timeFrame: Up to 12 months
measure: Time Spent by the Health Care Providers (HCPs) During Medical Appointments
timeFrame: Up to 12 months
measure: Mean Change in Patient Activation Measure (PAM-13)
timeFrame: From Month 0 to Month 12
measure: Mean Change in Beliefs about Medication Questionnaire (BMQ)
timeFrame: From Month 0 to Month 12
measure: Change in Work Productivity and Activity Impairment- General Health (WPAI-GH)
timeFrame: From Month 0 to Month 12
measure: Number of Outpatient Visits (in-office and remote) in Hospital Setting
timeFrame: Up to 12 months
measure: Number of Days of Sick Leaves
timeFrame: Up to 12 months
measure: Proportion of patients who are still on adalimumab after 6 and 12 months
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Lisbon
country: Portugal
facility: Instituto Portugues De Reumatologia /ID# 205963
state: Lisboa
city: Lisbon
country: Portugal
facility: Centro Hosp de Lisboa Central /ID# 205698
state: Lisboa
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328
state: Lisboa
city: Lisbon
country: Portugal
facility: Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330
state: Lisboa
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 201322
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 201323
city: Braga
country: Portugal
facility: CCA Braga - Hospital de Braga /ID# 201324
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 201335
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 201336
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, EPE /ID# 201337
city: Lisbon
country: Portugal
facility: Hospital Santo Antonio dos Cap /ID# 205700
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE /ID# 203535
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE /ID# 206278
city: Viseu
country: Portugal
facility: Centro Hosp de Tondela-Viseu /ID# 203774
city: Viseu
country: Portugal
facility: Centro Hosp de Tondela-Viseu /ID# 203775
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References: