Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary (VALUE)

Sponsor
AbbVie
Study ID
NCT02750800
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Adalimumab — BIOLOGICAL
    Pre-filled syringe or pen, administered by subcutaneous injection
  • AbbVie Care 2.0 — BEHAVIORAL
    Supportive services provided to participants included reminder calls, emails, text messages, nursing services, dietician, and psychological support. An adalimumab starter pack, injection guide, digital and print educational materials were also provided.

Study Details

The objective of this post-marketing observational study (PMOS) was to evaluate the effectiveness of adalimumab plus the AbbVie Care 2.0 patient support program in participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) in the routine clinical setting in Hungary.

Key Dates

Start date
Apr 7, 2016
Status verified
Sep 2019
Primary completion
Apr 3, 2018
Completion
Apr 3, 2018

Study Design

Enrollment
427 participants (actual)

Arms

  • Arm: Adalimumab and AbbVie Care 2.0
    Adalimumab administered via subcutaneous (SC) injection for 12 months according to the approved EMA label and Hungarian financial protocols and supportive services via the AbbVie Care 2.0 patient support program

Primary Outcome Measure

Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months [ Time Frame: Baseline (Month 0) and 12 months ]

Related Studies