HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis

October 7, 2021 updated by: AbbVie

HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)

This study evaluates the long- term safety and effectiveness of adalimumab in participants with non-infectious intermediate-, posterior-, or pan-uveitis in daily practice in Japan.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

259

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

  • Japan
      • Kagoshima, Japan, 890-8520
        • Kagoshima Uni Med and Dental /ID# 164150
      • Kakogawa, Japan, 489-0065
        • Kakogawa Central City Hospital /ID# 167706
      • Miyakonojo, Japan, 885-0051
        • Miyata Ophthalmic Hospital /ID# 167707
      • Nishinomiya-shi, Japan, 663-8501
        • Duplicate_The Hospital of Hyogo College /ID# 166913
      • Omihachiman, Japan, 523-0082
        • Omihachiman Community Med Ctr /ID# 164978
      • Osaka, Japan, 572-0854
        • Osaka Hospital /ID# 164151
      • Osaka-shi, Japan
        • Yodogawa Christian Hospital /ID# 161741
      • Seto, Japan, 489-8642
        • Tosei General Hospital /ID# 167708
      • Tokorozawa, Japan, 359-0042
        • Natl Defense Med College Hosp /ID# 162946
      • Tokyo, Japan, 108-6303
        • Abbott Japan /ID# 147893
      • Tokyo, Japan, 162-8543
        • Tokyo Shinjuku Medical Center /ID# 166934
      • Tottori, Japan, 680-8501
        • Tottori Municipal Hospital /ID# 159431
    • Chiba
      • Urayasu-shi, Chiba, Japan, 279-0021
        • Juntendo University Urayasu Hospital /ID# 168358
    • Ehime
      • Matsuyama-shi, Ehime, Japan, 790-0826
        • Matsuyama Red Cross Hospital /ID# 164149
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital /ID# 163042
      • Fukuoka-shi, Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital /ID# 163043
      • Kurume-shi, Fukuoka, Japan, 830-0011
        • Kurume University Hospital /ID# 162945
    • Gunma
      • Maebashi-shi, Gunma, Japan, 371-8511
        • Gunma University Hospital /ID# 166916
    • Hiroshima
      • Hiroshima-shi, Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital /ID# 166915
    • Hokkaido
      • Sapporo-shi, Hokkaido, Japan, 060-8648
        • Hokkaido University Hospital /ID# 163041
    • Hyogo
      • Kobe-shi, Hyogo, Japan, 650-0017
        • Kobe University Hospital /ID# 165250
    • Ishikawa
      • Kanazawa-shi, Ishikawa, Japan, 920-8641
        • Duplicate_Kanazawa University Hospital /ID# 166914
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 240-8555
        • Yokohama Municipal Citizen's Hospital /ID# 161742
    • Kochi
      • Nankoku-shi, Kochi, Japan, 783-8505
        • Kochi Medical School Hospital /ID# 164144
    • Nagano
      • Matsumoto-shi, Nagano, Japan, 390-8621
        • Shinshu University Hospital /ID# 164153
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8520
        • Niigata University Medical & Dental Hospital /ID# 169563
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0871
        • Osaka University Hospital /ID# 164147
    • Saitama
      • Iruma-gun, Saitama, Japan, 350-0451
        • Saitama Medical University Hospital /ID# 162944
    • Tochigi
      • Shimotsuga-gun, Tochigi, Japan, 321-0293
        • Dokkyo Medical University Hospital /ID# 164154
    • Tokushima
      • Tokushima-shi, Tokushima, Japan, 770-8503
        • Tokushima University Hospital /ID# 164145
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 169564
      • Bunkyo-ku, Tokyo, Japan, 113-8519
        • Tokyo Medical And Dental University, Medical Hospital /ID# 165251
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Nippon Medical School Hospital /ID# 166938
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • The University of Tokyo Hospital /ID# 162943
      • Minato-ku, Tokyo, Japan, 105-8471
        • The Jikei University Hospital /ID# 164152
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital /ID# 164146
      • Shinjuku-ku, Tokyo, Japan, 162-8655
        • Center Hospital of the National Center for Global Health and Medicine /ID# 164148
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Tokyo Women's Medical University Hospital /ID# 165248
    • Yamaguchi
      • Ube-shi, Yamaguchi, Japan, 755-8505
        • Yamaguchi University Hospital /ID# 165249

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

Ages Eligible for Study

1 second to 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Participants with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Description

Inclusion Criteria:

  • Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Exclusion Criteria:

  • Participants previously treated with adalimumab

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Participants receiving adalimumab
Participants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse drug reactions (ADR)
Time Frame: Up to Week 52
ADR is the causal relationship between adalimumab and adverse events.
Up to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Visual Functioning Questionnaire (VFQ)-25 score
Time Frame: From Week 0 (baseline) to Week 52
The National Eye Institute VFQ-25 is an ocular disease-specific survey that measures the influence of visual disability and visual symptoms on generic health domains such as emotional well-being and social functioning, in addition to task-oriented domains related to daily visual functioning. The VFQ-25 consists of a base set of 25 vision-targeted questions plus an additional single-item general health rating question. The overall composite score ranges from 0 to 100, where higher scores or increases in score indicate better vision-related functioning.
From Week 0 (baseline) to Week 52
Change in Visual acuity in each eye
Time Frame: From Week 0 (baseline) to Week 52
Visual acuity change is assessed.
From Week 0 (baseline) to Week 52
Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye
Time Frame: From Week 0 (baseline) to Week 52

Slit lamp examinations will be conducted at each visit to assess AC cell count. The number of AC cells observed within a 1 mm × 1 mm slit beam will be used to determine the grade according to the Standardization of Uveitis Nomenclature (SUN) criteria:

Grade 0 = < 1 cell

Grade 0.5+ = 1 - 5 cells

Grade 1+ = 6 - 15 cells

Grade 2+ = 16 - 25 cells

Grade 3+ = 26 - 50 cells

Grade 4+ = > 50 cells.
From Week 0 (baseline) to Week 52
Percentage of Overall improvement
Time Frame: Up to Week 52
This is assessed by physicians.
Up to Week 52
Change in retinal lesions in each eye
Time Frame: From Week 0 (baseline) to Week 52
The change in retinal lesion are assessed.
From Week 0 (baseline) to Week 52
Change in central retinal thickness in each eye
Time Frame: From Week 0 (baseline) to Week 52
This is assessed by Optical Coherence Tomography (OCT)
From Week 0 (baseline) to Week 52
Change in Vitreous Haze grade in each eye
Time Frame: From Week 0 (baseline) to Week 52

Vitreous haze will be measured using dilated indirect ophthalmoscopy (DIO) and assessed by the Investigator according to National Eye Institute (NEI)/ SUN criteria:

Grade 0: No evident vitreous haze;

Grade 0.5+: Slight blurring of the optic disc margin because of the haze; normal striations and reflex of the nerve fiber layer cannot be visualized;

Grade 1+: Permits a better definition of both the optic nerve head and the retinal vessels (compared to higher grades);

Grade 2+: Permits better visualization of the retinal vessels (compared to higher grades);

Grade 3+: Permits the observer to see the optic nerve head, but the borders are quite blurry;

Grade 4+: Optic nerve head is obscured.
From Week 0 (baseline) to Week 52

Collaborators and Investigators

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

Sponsor

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.

General Publications

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)

November 15, 2016

Primary Completion (Actual)

October 14, 2020

Study Completion (Actual)

October 14, 2020

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 24, 2016

First Posted (Estimate)

September 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 7, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P15-665

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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