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

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Brief 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

Official 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

Brief Summary

      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 Type

Observational


Primary Outcome

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

Secondary Outcome

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

Condition

Uveitis


Study Arms / Comparison Groups

 Participants receiving adalimumab (Humira®)
Description:  Participants with active non- infectious intermediate, posterior or panuveitis receiving adalimumab (Humira®).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

155

Start Date

June 20, 2017

Completion Date

February 24, 2020

Primary Completion Date

February 24, 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

AbbVie Inc., , 

Location Countries

Austria

Location Countries

Austria

Administrative Informations


NCT ID

NCT03155243

Organization ID

P16-537


Responsible Party

Sponsor

Study Sponsor

AbbVie


Study Sponsor

AbbVie Inc., Study Director, AbbVie


Verification Date

March 2020