Post-marketing Observational Study to Evaluate the Incremental Impact of AbbVie's Patient Support… (NCT02750800) | Clinical Trial Compass
CompletedNot Applicable
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)
427 participantsStarted 2016-04-07
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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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
What they're measuring
1
Mean Change From Baseline in Short Form 36 Version 2.0 (SF-36 V2) Physical Component Summary (PCS) Score at 12 Months