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)

February 9, 2021 updated by: AbbVie

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8010
        • Medizinische Universität Graz /ID# 206301
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medical University of Vienna /ID# 206190
  • Colombia
      • Bucaramanga, Colombia, 680001
        • Foscal /Id# 207362
      • Medellín, Colombia, 050010
        • Fundacion hospitalaria San Vicente de Paul /ID# 208295
    • Atlantico
      • Barranquilla, Atlantico, Colombia, 080020
        • Clinica Oftalmologica del Caribe /ID# 206448
  • Czechia
      • Prague, Czechia, 128 08
        • Vseobecna Fakultni Nemocnice /ID# 209530
  • Germany
      • Berlin, Germany, 13353
        • Charite Campus Virchow-Klinikum /ID# 204879
      • Hamburg, Germany, 20251
        • Universitätsklinikum Hamburg-Eppendorf /ID# 205234
      • Munster, Germany, 48145
        • St. Franziskus Hosp Muenster /ID# 206695
  • Greece
      • Athens, Greece, 11525
        • Omma /Id# 163750
      • Athens, Greece, 16675
        • Athens Eye Hospital /ID# 163751
      • Ioannina, Greece, 45500
        • University General Hospital of Ioannina /ID# 163752
      • Thessaloniki, Greece, 57001
        • Interbalkan Medical Center /ID# 163753
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 163647
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem /ID# 163646
  • Ireland
      • Dublin, Ireland, 2
        • Royal Victoria Eye and Ear Hos /ID# 163653
  • Israel
      • Ashkelon, Israel, 78278
        • Barzilai Medical Center /ID# 163025
      • Haifa, Israel, 3339419
        • Bnai Zion Medical Center /ID# 163026
      • Ramat Gan, Israel, 5262100
        • Sheba Medical Center /ID# 163109
    • Tel-Aviv
      • Petakh Tikva, Tel-Aviv, Israel, 4941492
        • Rabin Medical Center /ID# 163108
      • Tel Aviv-Yafo, Tel-Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Ctr /ID# 163024
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 91120
        • Hadassah Medical Center /ID# 169305
  • Kuwait
      • Kuwait, Kuwait, 35151
        • Albahar Ophtalmology Center /ID# 210124
  • Lebanon
      • Beirut, Lebanon, 1107
        • American University of Beirut /ID# 210122
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital, Universitaetsklinik /ID# 201027
      • Lausanne, Switzerland, 1000
        • Hop Ophtalmique Jules Gonin /ID# 201028
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8063
        • Stadtspital Triemli /ID# 206204
  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates
        • Cleveland Clinic Abu Dhabi /ID# 210123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants with diagnosed active non- infectious intermediate, posterior or panuveitis (NIIPPU) that are being treated with Humira® as per locally approved label and prescription guidelines.

Description

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:

    1. Active, inflammatory, chorioretinal and/or inflammatory retinal vascular lesion
    2. >= 2+ anterior chamber cells [Standardization of Uveitis Nomenclature (SUN) criteria]
    3. >= 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Participants receiving adalimumab (Humira®)
Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to Month 12
Percent change in Presenteeism
Time Frame: Up to Month 12
Assessing percent change in presenteeism
Up to Month 12
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.
Up to Month 12
Percent Change in Total activity impairment
Time Frame: Up to Month 12
Assessing Percent Change in Total activity impairment
Up to Month 12
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
From Month 1 to Month 12
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
From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
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.
Up to Month 12
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)
From Month 1 to Month 12
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
From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
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)
From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
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.
Up to Month 12
Percent change in Absenteeism
Time Frame: Up to Month 12
Assessing percent change in absenteeism
Up to Month 12
Percent Change in Total work productivity impairment
Time Frame: Up to Month 12
Assessing Percent Change in Total work productivity impairment
Up to Month 12
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
From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
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
From 6 months prior to treatment start (Week 0 [baseline]) to 12 months after treatment start (total 18 months)
Change from baseline in intraocular pressure
Time Frame: From Month 1 to Month 12
Assessing change from baseline in intraocular pressure
From Month 1 to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 20, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 24, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 24, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P16-537

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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