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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)

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ClinicalTrials.gov Identifier: NCT02750800
Recruitment Status : Completed
First Posted : April 26, 2016
Last Update Posted : April 6, 2018
Sponsor:
Collaborator:
AdWare Research Kft.
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study aims at evaluate the effect of adalimumab with patient support program (PSP) on clinical, health economic, patient reported outcomes in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn's disease and ulcerative colitis in the routine clinical setting in Hungary.

Condition or disease
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Psoriasis Crohn's Disease Ulcerative Colitis

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Study Type : Observational
Actual Enrollment : 429 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Actual Study Start Date : April 7, 2016
Actual Primary Completion Date : April 3, 2018
Actual Study Completion Date : April 3, 2018


Group/Cohort
Patients with psoriatic arthritis
Patients with psoriatic arthritis
Patients with rheumatoid arthritis
Patients with rheumatoid arthritis
Patients with Crohn's disease
Patients with Crohn's disease
Patients with ulcerative colitis
Patients with ulcerative colitis
Patients with ankylosing spondylitis
Patients with ankylosing spondylitis
Patients with psoriasis
Patients with psoriasis



Primary Outcome Measures :
  1. Change from baseline (month 0) in 36-Item Short Form Health Survey, Version 2.0 (SF-36 V2) Physical Component Score (PCS) [ Time Frame: From Month 0 to 12 ]
    SF-36 V2 is a generic 36-item questionnaire measuring health-related quality of life (HRQL). It consists of 8 subscales. The PCS is represented by 4 subscales: physical function, role limitations due to physical problems, bodily pain, and general health perception. Participants self-report on items in a subscale that have choices per item. Scoring is done for both PCS subscale scores and summary scores; for each, the range is 0 (worst HRQL) to 100 (best HRQL).


Secondary Outcome Measures :
  1. Change from baseline (month 0) in total Satisfaction with Information About Medicines Scale (SIMS) score [ Time Frame: From Month 0 to 12 ]
    SIMS assesses whether the individual has received enough information about a range of topics relating to prescribed medication. Scores range from 0 to 17 with high scores indicating a high degree of overall satisfaction with the amount of medication information received.

  2. Change from baseline (month 0) in total Morisky Medication Adherence Scale, 4 questions (MMAS-4) score [ Time Frame: From Month 0 to 12 ]
    MMAS-4 is a tool to screen for compliance in Immune-mediated Inflammatory Disease (IMID) patients. It consists of four questions evaluating drug intake habits in patients on chronic therapies with a scoring scheme of "Yes" = 0 and "No" = 1. The items are summed to give a range of scores evaluated as high adherence (0), medium adherence (1-2) or low adherence (3-4).

  3. Change from baseline (month 0) in EuroQol five-dimension scale (EQ-5D-5L) quality of life score [ Time Frame: From Month 0 to 12 ]
    EQ-5D-5L is a widely-used survey instrument for measuring economic preferences for health states, a standardized, self-administered, generic instrument to measure health outcome.

  4. Changes from baseline (month 0) in Work Productivity and Activity Impairment (WPAI) Specific Health Problem (SHP) score [ Time Frame: From Month 0 to 12 ]
    This is a patient-reported quantitative assessment of the amount of absenteeism, presenteeism and daily activity impairment attributable to a specific health problem.

  5. Change from baseline (month 0) in total Treatment Satisfaction Questionnaire for Medication (TSQM)-1.4 score [ Time Frame: From Month 0 to 12 ]
    TSQM is a generic measure of treatment satisfaction for medication, was rigorously developed with sound psychometric properties. TSQM Ver 1.4 (14 items) includes domains like effectiveness, side effects, convenience and global satisfaction.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), psoriasis (Ps), Crohn's disease (CD) and ulcerative colitis (UC).
Criteria

Inclusion Criteria:

  • Diagnosis of RA, AS, PsA, Ps, CD or UC by treating physician.
  • RA, AS, PsA, Ps, UC or CD patients whom adalimumab treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional/reimbursement guidelines.
  • Subjects assigned to adalimumab treatment not more than 1 month prior to inclusion.
  • Patient to whom participation in AbbVie CARE 2.0 Patient Support Program (PSP) program was offered and patient decided to join and has started the PSP.
  • Patients 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:

  • Patients who cannot be treated with adalimumab according to the local adalimumab SmPC and local professional and reimbursement guidelines.
  • Patients treated with > 1 prior biologic DMARD for RA, AS, PsA, Ps, UC or CD.
  • Prior treatment with adalimumab for more than 1 month.
  • Patients currently participating in other clinical research.
  • Patients who are unwilling or unable to complete the quality of life and other patient reported questionnaires.
  • Patients who choose not to participate in ABBVIE Care 2.0.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02750800


Locations
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Hungary
Pecsi Tudomanyegyetem
Pécs, Pecs, Hungary, 7624
Markusovszky Egyetemi Oktatókórház
Szombathely, Vas, Hungary, 9700
Budai Irgalmasrendi Korhaz
Budapest, Hungary, 1023
MH Honvedkorhaz
Budapest, Hungary, 1062
Semmelweis Egyetem
Budapest, Hungary, 1085
Szent Janos Korhaz
Budapest, Hungary, 1125
Debreceni Egyetem Klinikai Koz
Debrecen, Hungary, 4032
Petz Aladar Megyei Oktato Korh
Gyor, Hungary, 9023
Bekes Megyei Pandy Kalman Korh
Gyula, Hungary, 5700
Hevizgyogyfurdo es Szent Andra
Heviz, Hungary, 8380
Somogy Megyei Kaposi Mor Oktat
Kaposvár, Hungary, 7400
Bacs-Kiskun Megyei Korhaz
Kecskemét, Hungary, 6000
Pest Megyei Flor Ferenc Korhaz
Kistarcsa, Hungary, 2143
BAZ Megyei E.O. Korhaz
Miskolc, Hungary, 3526
HUNIKO Egeszsegugyi Szolgaltat
Miskolc, Hungary, 3533
Josa Andras Oktato Korhaz
Nyíregyháza, Hungary, 4400
Szegedi Tudomanyegyetem
Szeged, Hungary, 6720
Fejer Megyei Szent Gyorgy Korh
Szekesfehervar, Hungary, 8000
Tolna Megyei Onkormanyzat Bala
Szekszard, Hungary, 7100
Sponsors and Collaborators
AbbVie
AdWare Research Kft.
Investigators
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Study Director: AbbVie Inc. AbbVie

Additional Information:
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02750800     History of Changes
Other Study ID Numbers: P15-673
First Posted: April 26, 2016    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie:
Rheumatoid arthritis
Ankylosing spondylitis
Psoriatic arthritis
Psoriasis
Crohn's disease
Ulcerative colitis
Patient support program
Quality of life
Patient related outcomes
Observational study

Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Psoriasis
Crohn Disease
Colitis
Ulcer
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Spondylitis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes
Bone Diseases, Infectious
Infection
Bone Diseases
Spinal Diseases
Spondylarthropathies