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

NCT03155243 | Completed

• 1 other identifier: P16-537
• Study Type: observational
• Target: 155
• Locations: 12 countries
• Sites: 28

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.

Conditions

Uveitis

Keywords

Humira®; Adalimumab; Ocular inflammation; Active non-infectious intermediate, posterior and panuveitis

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (16)

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

  Up to Month 12

• Percent change in Presenteeism

  Up to Month 12

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

  Up to Month 12

• Percent Change in Total activity impairment

  Up to Month 12

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

  From Month 1 to Month 12

Study Arms (1)

Participants receiving adalimumab (Humira®)

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (28)

Medizinische Universität Graz /ID# 206301

Graz, Styria, 8010, Austria

Location

Medical University of Vienna /ID# 206190

Vienna, Vienna, 1090, Austria

Location

Clinica Oftalmologica del Caribe /ID# 206448

Barranquilla, Atlántico, 080020, Colombia

Location

Foscal /Id# 207362

Bucaramanga, 680001, Colombia

Location

Fundacion hospitalaria San Vicente de Paul /ID# 208295

Medellín, 050010, Colombia

Location

Vseobecna Fakultni Nemocnice /ID# 209530

Prague, 128 08, Czechia

Location

Charite Campus Virchow-Klinikum /ID# 204879

Berlin, 13353, Germany

Location

Universitätsklinikum Hamburg-Eppendorf /ID# 205234

Hamburg, 20251, Germany

Location

St. Franziskus Hosp Muenster /ID# 206695

Münster, 48145, Germany

Location

Omma /Id# 163750

Athens, 11525, Greece

Location

Athens Eye Hospital /ID# 163751

Athens, 16675, Greece

Location

University General Hospital of Ioannina /ID# 163752

Ioannina, 45500, Greece

Location

Interbalkan Medical Center /ID# 163753

Thessaloniki, 57001, Greece

Location

Semmelweis Egyetem /ID# 163647

Budapest, 1085, Hungary

Location

Szegedi Tudomanyegyetem /ID# 163646

Szeged, 6720, Hungary

Location

Royal Victoria Eye and Ear Hos /ID# 163653

Dublin, 2, Ireland

Location

Hadassah Medical Center /ID# 169305

Jerusalem, Jerusalem, 91120, Israel

Location

Rabin Medical Center /ID# 163108

Petakh Tikva, Tel Aviv, 4941492, Israel

Location

Tel Aviv Sourasky Medical Ctr /ID# 163024

Tel Aviv, Tel Aviv, 6423906, Israel

Location

Barzilai Medical Center /ID# 163025

Ashkelon, 78278, Israel

Location

Bnai Zion Medical Center /ID# 163026

Haifa, 3339419, Israel

Location

Sheba Medical Center /ID# 163109

Ramat Gan, 5262100, Israel

Location

Albahar Ophtalmology Center /ID# 210124

Kuwait City, 35151, Kuwait

Location

American University of Beirut /ID# 210122

Beirut, 1107, Lebanon

Location

Stadtspital Triemli /ID# 206204

Zurich, Canton of Zurich, 8063, Switzerland

Location

Inselspital, Universitaetsklinik /ID# 201027

Bern, 3010, Switzerland

Location

Hop Ophtalmique Jules Gonin /ID# 201028

Lausanne, 1000, Switzerland

Location

Cleveland Clinic Abu Dhabi /ID# 210123

Abu Dhabi, United Arab Emirates

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Uveitis; Panuveitis

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: May 16, 2017
• Study Start: June 20, 2017
• Primary Completion: February 24, 2020
• Study Completion: February 24, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

GR (4); IE (1); HU (2); CH (3); CO (3); KU (1); DE (3); LE (1); AE (1); CZ (1); IL (6); AU (2)