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

NCT ID: NCT03223012

Last Updated: 2020-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

116 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-15

Study Completion Date

2019-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants not included in the AbbVie care program

Participants receiving adalimumab not included in the AbbVie care patient support program.

No interventions assigned to this group

Participants included in the AbbVie care program

Participants receiving adalimumab included in the AbbVie care patient support program.

No interventions assigned to this group

Eligibility Criteria

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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


* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Instituto Portugues De Reumatologia /ID# 205963

Lisbon, Lisbon District, Portugal

Site Status

Centro Hosp de Lisboa Central /ID# 205698

Lisbon, Lisbon District, Portugal

Site Status

Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328

Lisbon, Lisbon District, Portugal

Site Status

Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330

Lisbon, Lisbon District, Portugal

Site Status

CCA Braga - Hospital de Braga /ID# 201322

Braga, , Portugal

Site Status

CCA Braga - Hospital de Braga /ID# 201323

Braga, , Portugal

Site Status

CCA Braga - Hospital de Braga /ID# 201324

Braga, , Portugal

Site Status

Hospital Santo Antonio dos Cap /ID# 205700

Lisbon, , Portugal

Site Status

Centro Hospitalar Lisboa Norte, EPE /ID# 201335

Lisbon, , Portugal

Site Status

Centro Hospitalar Lisboa Norte, EPE /ID# 201336

Lisbon, , Portugal

Site Status

Centro Hospitalar Lisboa Norte, EPE /ID# 201337

Lisbon, , Portugal

Site Status

Centro Hospitalar de Sao Joao, EPE /ID# 203535

Porto, , Portugal

Site Status

Centro Hospitalar de Sao Joao, EPE /ID# 206278

Porto, , Portugal

Site Status

Centro Hosp de Tondela-Viseu /ID# 203774

Viseu, , Portugal

Site Status

Centro Hosp de Tondela-Viseu /ID# 203775

Viseu, , Portugal

Site Status

Countries

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Portugal

Other Identifiers

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P16-321

Identifier Type: -

Identifier Source: org_study_id

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