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

Last updated: February 20, 2020
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Joint Injuries

Warts

Scalp Disorders

Treatment

N/A

Clinical Study ID

NCT03223012
P16-321
  • Ages 18-99
  • All Genders

Study 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

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., theprescription of adalimumab was clearly separated from the decision to include theparticipants 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 usepersonal health information (informed consent), and to agree that data will becollected 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

Exclusion Criteria:

  • Definitive discontinuation of adalimumab before being proposed to participate in thestudy

  • Participated in any clinical experimental research within the 2 months prior toenrollment

  • Pregnant or breastfeeding female participants

  • Participant not able or not willing to comply with the requirements of this studyprotocol.

Study Design

Total Participants: 116
Study Start date:
November 15, 2017
Estimated Completion Date:
February 28, 2019

Connect with a study center

  • Centro Hosp de Lisboa Central /ID# 205698

    Lisbon, Lisboa 1169-050
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201328

    Lisbon, Lisboa 1349-019
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Ocidental, EPE /ID# 201330

    Lisbon, Lisboa 1349-019
    Portugal

    Site Not Available

  • Instituto Portugues De Reumatologia /ID# 205963

    Lisbon, Lisboa 1050-034
    Portugal

    Site Not Available

  • CCA Braga - Hospital de Braga /ID# 201322

    Braga, 4710-243
    Portugal

    Site Not Available

  • CCA Braga - Hospital de Braga /ID# 201323

    Braga, 4710-243
    Portugal

    Site Not Available

  • CCA Braga - Hospital de Braga /ID# 201324

    Braga, 4710-243
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201335

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201336

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Norte, EPE /ID# 201337

    Lisboa, 1649-035
    Portugal

    Site Not Available

  • Hospital Santo Antonio dos Cap /ID# 205700

    Lisbon, 1150-069
    Portugal

    Site Not Available

  • Centro Hospitalar de Sao Joao, EPE /ID# 203535

    Porto, 4200-319
    Portugal

    Site Not Available

  • Centro Hospitalar de Sao Joao, EPE /ID# 206278

    Porto, 4200-319
    Portugal

    Site Not Available

  • Centro Hosp de Tondela-Viseu /ID# 203774

    Viseu, 3504 - 509
    Portugal

    Site Not Available

  • Centro Hosp de Tondela-Viseu /ID# 203775

    Viseu, 3504 - 509
    Portugal

    Site Not Available

  • Hospital do Espirito Santo de Evora

    Évora, 7000
    Portugal

    Site Not Available

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