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

NCT ID: NCT03155243

Last Updated: 2021-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-20

Study Completion Date

2020-02-24

Brief Summary

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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.

Detailed Description

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Conditions

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Uveitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants receiving adalimumab (Humira®)

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Medizinische Universität Graz /ID# 206301

Graz, Styria, Austria

Site Status

Medical University of Vienna /ID# 206190

Vienna, Vienna, Austria

Site Status

Clinica Oftalmologica del Caribe /ID# 206448

Barranquilla, Atlántico, Colombia

Site Status

Foscal /Id# 207362

Bucaramanga, , Colombia

Site Status

Fundacion hospitalaria San Vicente de Paul /ID# 208295

Medellín, , Colombia

Site Status

Vseobecna Fakultni Nemocnice /ID# 209530

Prague, , Czechia

Site Status

Charite Campus Virchow-Klinikum /ID# 204879

Berlin, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf /ID# 205234

Hamburg, , Germany

Site Status

St. Franziskus Hosp Muenster /ID# 206695

Münster, , Germany

Site Status

Omma /Id# 163750

Athens, , Greece

Site Status

Athens Eye Hospital /ID# 163751

Athens, , Greece

Site Status

University General Hospital of Ioannina /ID# 163752

Ioannina, , Greece

Site Status

Interbalkan Medical Center /ID# 163753

Thessaloniki, , Greece

Site Status

Semmelweis Egyetem /ID# 163647

Budapest, , Hungary

Site Status

Szegedi Tudomanyegyetem /ID# 163646

Szeged, , Hungary

Site Status

Royal Victoria Eye and Ear Hos /ID# 163653

Dublin, , Ireland

Site Status

Hadassah Medical Center /ID# 169305

Jerusalem, Jerusalem, Israel

Site Status

Rabin Medical Center /ID# 163108

Petakh Tikva, Tel Aviv, Israel

Site Status

Tel Aviv Sourasky Medical Ctr /ID# 163024

Tel Aviv, Tel Aviv, Israel

Site Status

Barzilai Medical Center /ID# 163025

Ashkelon, , Israel

Site Status

Bnai Zion Medical Center /ID# 163026

Haifa, , Israel

Site Status

Sheba Medical Center /ID# 163109

Ramat Gan, , Israel

Site Status

Albahar Ophtalmology Center /ID# 210124

Kuwait City, , Kuwait

Site Status

American University of Beirut /ID# 210122

Beirut, , Lebanon

Site Status

Stadtspital Triemli /ID# 206204

Zurich, Canton of Zurich, Switzerland

Site Status

Inselspital, Universitaetsklinik /ID# 201027

Bern, , Switzerland

Site Status

Hop Ophtalmique Jules Gonin /ID# 201028

Lausanne, , Switzerland

Site Status

Cleveland Clinic Abu Dhabi /ID# 210123

Abu Dhabi, , United Arab Emirates

Site Status

Countries

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Austria Colombia Czechia Germany Greece Hungary Ireland Israel Kuwait Lebanon Switzerland United Arab Emirates

Other Identifiers

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P16-537

Identifier Type: -

Identifier Source: org_study_id

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