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Completed

NCT Number: NCT03155243

Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice

This study aims at evaluating real life effectiveness of originator adalimumab (Humira®) participants with active non-infectious intermediate, posterior and panuveitis (NIIPPU) despite high-dose corticosteroid therapy; including effect on ocular inflammation, health-related quality of life, health resource utilization, work ability and medication burden, as well as describe the characteristics of NIIPPU participants treated with Humira® in the real-life setting.

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Key information

Conditions

Uveitis Eye Diseases Panuveitis Uveal Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical University of Vienna /ID# 206190, Vienna, State of Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants voluntarily signed a patient authorization form to use and disclose personal health information (or informed consent, where applicable).
  • Age >= 18 years at the time of the enrollment.
  • Diagnosis of active NIIPP uveitis as defined by the presence of at least 1 of the following parameters:
  • Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
  • >= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
  • >= 2+ vitreous haze [National Eye Institute (NEI)/SUN criteria]
  • Humira® treatment is indicated as per local Summary of Product Characteristics (SmPC) and professional and/or reimbursement guidelines.
  • Decision on the treatment with Humira® was made prior to any decision to approach the patient to participate in this study.

Exclusion criteria

  • Participants who cannot be treated with Humira® according to the local Humira® SmPC and/or local professional and reimbursement guidelines.
  • Prior treatment with Humira®, including current course of Humira® started prior to baseline visit assessments.
  • Participants currently participating in other clinical research.
  • Participants who are unwilling or unable to complete the quality of life and other patient reported questionnaires.

Treatment and study plan

Primary outcomes

  1. Proportion of participants who achieve treatment response at any of the follow-up visits

    Time frame: Up to Month 12

    Definition of response: "quiescence" defined as patients with no new active chorioretinal inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.

Secondary outcomes

  1. Proportion of participants with maintained response at any of follow up visits

    Time frame: Up to Month 12

    Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.

  2. Percent change in Presenteeism

    Time frame: Up to Month 12

    Assessing percent change in presenteeism

  3. Proportion of participants with maintained response separately for each follow-up visit

    Time frame: Up to Month 12

    Maintained response is defined as quiescence achieved at respective prior visit and no flare at current visit.

  4. Percent Change in Total activity impairment

    Time frame: Up to Month 12

    Assessing Percent Change in Total activity impairment

  5. Changes in total score of Work Productivity & Activity Impairment (WPAI)-UV score

    Time frame: From Month 1 to Month 12

    Assessing changes in total score of WPAI-UV score

  6. Change in emergency room admissions

    Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)

    Assessing change in emergency room admissions

  7. Proportion of participants with treatment response separately for each follow-up visit

    Time frame: Up to Month 12

    Response is defined as participants with no new active inflammatory lesions and having anterior chamber (AC) cell and vitreous haze (VH) grade of <=0.5+ in both eyes.

  8. Change from baseline in Best corrected visual acuity (BCVA)

    Time frame: From Month 1 to Month 12

    Assessing change from baseline in Best corrected visual acuity (BCVA)

  9. Change in cumulative hospital admissions

    Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)

    Assessing change in cumulative hospital admissions

  10. Change from baseline in Central Retinal Thickness (CRT)

    Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)

    Assessing change from baseline in Central Retinal Thickness (CRT)

  11. Proportion of participants with flare at any of follow up visit

    Time frame: Up to Month 12

    Flare is defined as new active inflammatory lesions or AC cell grade of >=2+ or VH grade of >=2+ at least in one eye.

  12. Percent change in Absenteeism

    Time frame: Up to Month 12

    Assessing percent change in absenteeism

  13. Percent Change in Total work productivity impairment

    Time frame: Up to Month 12

    Assessing Percent Change in Total work productivity impairment

  14. Change in outpatient visits

    Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)

    Assessing change in outpatient visits

  15. Change in hospitalization days prior to and during Humira® treatment

    Time frame: From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)

    Assessing change in hospitalization days prior to and during Humira® treatment

  16. Change from baseline in intraocular pressure

    Time frame: From Month 1 to Month 12

    Assessing change from baseline in intraocular pressure

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

Impact of Humira® Therapy on Ocular Inflammation, Selected Health Care Resource Utilization and Patient Reported Outcomes in Patients With Active Non-infectious Intermediate, Posterior and Panuveitis in Routine Clinical Practice -HOPE

Acronym: HOPE

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
May 16, 2017
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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