Clinical trial NCT02750800: 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)
Official title: Post-marketing Observational Study to Evaluate the Effect of HUMIRA (Adalimumab) Treatment With AbbVie's Patient Support Program on Patient Reported Outcomes and Health Resource Utilization in Inflammatory Arthritis, Psoriasis and Inflammatory Bowel Diseases in Hungary in a Real-life Setting: VALUE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Ankylosing Spondylitis
Psoriatic Arthritis
Psoriasis
Crohn's Disease
Ulcerative Colitis
Keywords: Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthritis
Psoriasis
Crohn's disease
Ulcerative colitis
Patient support program
Quality of life
Patient related outcomes
Observational study
Adalimumab
Humira
Adherence
Health-related quality of life
Healthcare resource utilization
Disease activity
Treatment satisfaction
Workability
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-04-26
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC)

Brief summary: 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.

Detailed description: This was a prospective, open label, multicenter, observational cohort study. Adalimumab was prescribed in the usual manner in accordance with the terms of the local marketing authorization and professional and reimbursement guidelines with regards to dose, population and indication. AbbVie offered an array of services as part of a patient support program, called AbbVie Care 2.0, to study participants. The purpose of the AbbVie Care 2.0 program was to provide educational resources that aimed to help participants understand their health condition and disease management (e.g., lifestyle - exercise or diet), but also help to them understand how to administer the product safely and be empowered to stay on track with their prescribed treatment plan, all with the goal of maximizing patient outcomes. There were five target visits: a baseline visit at enrollment and follow-up visits at 3, 6, 9 and 12 months.

Eligibility criteria: Inclusion criteria:

* Diagnosis of rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC) by the treating physician
* Age ≥ 18 years at the time of enrollment
* RA, AS, PsA, Ps, UC or CD patients for whom adalimumab treatment was indicated as per local Summary of Product Characteristics (SmPC) and professional/reimbursement guidelines
* Participants assigned to adalimumab treatment not more than 1 month prior to inclusion
* Participants to whom participation in AbbVie Care 2.0 Patient Support Program (PSP) program was offered and participant decided to join and had started the PSP
* Participants willing to be involved in the study and to sign patient informed consent form (ICF) and subject information form (SIF) in order to allow use and disclosure of his/her personal health information

Exclusion Criteria:

* Participants who could not be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines
* Participants treated with \> 1 prior biologic disease modifying anti rheumatic drug (DMARD) for RA, AS, PsA, Ps, UC or CD
* Prior treatment with adalimumab for more than 1 month
* Participants currently participating in other clinical research studies
* Participants who were unwilling or unable to complete the quality of life and other patient-reported questionnaires

Primary outcomes:
measure: Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
Secondary outcomes:
measure: Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Short Quality of Life in Inflammatory Bowel Disease Questionnaire (SIBDQ) Score at 12 Months in Participants With Crohn's Disease and Ulcerative Colitis
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 12 Months in Participants With Psoriasis and Psoriatic Arthritis
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) Score at 12 Months in Participants With Ankylosing Spondylitis and Participants With Psoriatic Arthritis With Axial Symptoms
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (TSQM) Version 1.4 Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Total Satisfaction With Information About Medicines Scale (SIMS) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Total Morisky Medication Adherence Scale, 4 Questions (MMAS-4) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospital Inpatient Days and Number of Sick Leave Days
timeFrame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)
measure: Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Hospitalizations and Number of Sick Leaves
timeFrame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)
measure: Mean Change From the 12 Months Prior to Treatment With Adalimumab to the 12 Months After Beginning Treatment With Adalimumab in Health Resource Utilization: Number of Outpatient Visits
timeFrame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)
measure: Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS ESR) at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Partial Mayo (pMayo) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 12 Months
timeFrame: Baseline (Month 0) and 12 months
measure: Participants' Rating of the AbbVie Care 2.0 Program at 12 Months
timeFrame: 12 months
measure: Correlation Between Disease Activity Scores and Disease-specific Quality of Life Scores
timeFrame: Baseline (Month 0) and 12 months
measure: Correlation Between the Length of AbbVie Care 2.0 Duration and Participant Outcomes
timeFrame: From Baseline (Month 0) to 12 months
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: Morisky DE, Green LW, Levine DM. Concurrent and predictive validity of a self-reported measure of medication adherence. Med Care. 1986 Jan;24(1):67-74. doi: 10.1097/00005650-198601000-00007.
citation: Morisky DE, Malotte CK, Choi P, Davidson P, Rigler S, Sugland B, Langer M. A patient education program to improve adherence rates with antituberculosis drug regimens. Health Educ Q. 1990 Fall;17(3):253-67. doi: 10.1177/109019819001700303.
citation: Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. No abstract available.