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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02750800
Date of registration: 13/04/2016
Prospective Registration: Yes
Primary sponsor: AbbVie
Public title: 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
Scientific 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
Date of first enrolment: April 7, 2016
Target sample size: 427
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02750800
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Hungary
Contacts
Name:     AbbVie Inc.
Address: 
Telephone:
Email:
Affiliation:  AbbVie
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 99 Years
Gender: All
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis
Crohn's Disease
Psoriasis
Psoriatic Arthritis
Rheumatoid Arthritis
Ulcerative Colitis
Intervention(s)
Behavioral: AbbVie Care 2.0
Biological: Adalimumab
Primary Outcome(s)
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]
Secondary Outcome(s)
Correlation Between Disease Activity Scores and Disease-specific Quality of Life Scores [Time Frame: Baseline (Month 0) and 12 months]
Correlation Between the Length of AbbVie Care 2.0 Duration and Participant Outcomes [Time Frame: From Baseline (Month 0) to 12 months]
Mean Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS ESR) at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
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 [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Clinical Disease Activity Index (CDAI) Score at 12 Months [Time Frame: 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 [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Disease Activity Score 28 (DAS28) at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in EuroQol 5 Dimension 5 Level (EQ-5D-5L) Index Score at 12 Months [Time Frame: 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 [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI-SHP) Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Partial Mayo (pMayo) Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Mental Component Summary (MCS) Score at 12 Months [Time Frame: 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 [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Total Morisky Medication Adherence Scale, 4 Questions (MMAS-4) Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Total Satisfaction With Information About Medicines Scale (SIMS) Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
Mean Change From Baseline in Treatment Satisfaction Questionnaire for Medicine (TSQM) Version 1.4 Score at 12 Months [Time Frame: Baseline (Month 0) and 12 months]
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 [Time Frame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)]
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 [Time Frame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)]
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 [Time Frame: 12 months prior to treatment start (Month 0 [baseline]) and 12 months after treatment start (total 24 months)]
Participants' Rating of the AbbVie Care 2.0 Program at 12 Months [Time Frame: 12 months]
Secondary ID(s)
P15-673
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available: Yes
Date Posted: 06/11/2019
Date Completed:
URL: https://clinicaltrials.gov/ct2/show/results/NCT02750800
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