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)
VALUE
1 other identifier
observational
427
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 7, 2016
CompletedFirst Submitted
Initial submission to the registry
April 13, 2016
CompletedFirst Posted
Study publicly available on registry
April 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 3, 2018
CompletedResults Posted
Study results publicly available
November 6, 2019
CompletedNovember 6, 2019
September 1, 2019
2 years
April 13, 2016
March 29, 2019
October 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months
The health assessment questionnaire Short Form 36 Version 2.0 (SF-36 V2 ) determines participants' overall quality of life by assessing 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality; 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health. Items 1-4 primarily contribute to the physical component summary score (PCS) of the SF-36. Items 5-8 primarily contribute to the mental component summary score (MCS) of the SF-36. Scores on each item are summed and averaged (range = 0 "worst"-100 "best"). Positive numbers indicate improvement from baseline.
Baseline (Month 0) and 12 months
Secondary Outcomes (21)
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months
Baseline (Month 0) and 12 months
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months
Baseline (Month 0) and 12 months
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Visual Analog Scale Score at 12 Months
Baseline (Month 0) and 12 months
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
Baseline (Month 0) and 12 months
Mean Change From Baseline in Dermatology Life Quality Index (DLQI) Score at 12 Months in Participants With Psoriasis and Psoriatic Arthritis
Baseline (Month 0) and 12 months
- +16 more secondary outcomes
Study Arms (1)
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
Interventions
Pre-filled syringe or pen, administered by subcutaneous injection
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.
Eligibility Criteria
Adult participants with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) or ulcerative colitis (UC)
You may qualify if:
- 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 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Related Publications (3)
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.
PMID: 3945130BACKGROUNDMorisky 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.
PMID: 2228629BACKGROUNDMorisky 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.
PMID: 21144706BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The key limitation of the study is the absence of a control group (participants treated with adalimumab without AbbVie Care 2.0). Given this limitation it is difficult to measure the impact of adding AbbVie Care 2.0 to adalimumab on study outcomes.
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2016
First Posted
April 26, 2016
Study Start
April 7, 2016
Primary Completion
April 3, 2018
Study Completion
April 3, 2018
Last Updated
November 6, 2019
Results First Posted
November 6, 2019
Record last verified: 2019-09