NCT02916017

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2016

Longer than P75 for all trials

Geographic Reach
1 country

39 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2020

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

3.9 years

First QC Date

September 14, 2016

Last Update Submit

October 7, 2021

Conditions

Uveitis

Keywords

HumiraAdalimumabNon-infectious Intermediate-, Posterior-, or Pan-uveitis

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse drug reactions (ADR)

    ADR is the causal relationship between adalimumab and adverse events.

    Up to Week 52

Secondary Outcomes (7)

  • Change in Visual Functioning Questionnaire (VFQ)-25 score

    From Week 0 (baseline) to Week 52

  • Change in Visual acuity in each eye

    From Week 0 (baseline) to Week 52

  • Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye

    From Week 0 (baseline) to Week 52

  • Percentage of Overall improvement

    Up to Week 52

  • Change in retinal lesions in each eye

    From Week 0 (baseline) to Week 52

  • +2 more secondary outcomes

Study Arms (1)

Participants receiving adalimumab

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

Eligibility Criteria

Age0 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Participants previously treated with adalimumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (39)

Juntendo University Urayasu Hospital /ID# 168358

Urayasu-shi, Chiba, 279-0021, Japan

Location

Matsuyama Red Cross Hospital /ID# 164149

Matsuyama, Ehime, 790-0826, Japan

Location

Kyushu University Hospital /ID# 163042

Fukuoka, Fukuoka, 812-8582, Japan

Location

Fukuoka University Hospital /ID# 163043

Fukuoka, Fukuoka, 814-0180, Japan

Location

Kurume University Hospital /ID# 162945

Kurume-shi, Fukuoka, 830-0011, Japan

Location

Gunma University Hospital /ID# 166916

Maebashi, Gunma, 371-8511, Japan

Location

Hiroshima University Hospital /ID# 166915

Hiroshima, Hiroshima, 734-8551, Japan

Location

Hokkaido University Hospital /ID# 163041

Sapporo, Hokkaido, 060-8648, Japan

Location

Kobe University Hospital /ID# 165250

Kobe, Hyōgo, 650-0017, Japan

Location

Duplicate_Kanazawa University Hospital /ID# 166914

Kanazawa, Ishikawa-ken, 920-8641, Japan

Location

Yokohama Municipal Citizen's Hospital /ID# 161742

Yokohama, Kanagawa, 240-8555, Japan

Location

Kochi Medical School Hospital /ID# 164144

Nankoku-shi, Kochi, 783-8505, Japan

Location

Shinshu University Hospital /ID# 164153

Matsumoto-shi, Nagano, 390-8621, Japan

Location

Niigata University Medical & Dental Hospital /ID# 169563

Niigata, Niigata, 951-8520, Japan

Location

Osaka University Hospital /ID# 164147

Suita-shi, Osaka, 565-0871, Japan

Location

Saitama Medical University Hospital /ID# 162944

Iruma-gun, Saitama, 350-0451, Japan

Location

Dokkyo Medical University Hospital /ID# 164154

Shimotsuga-gun, Tochigi, 321-0293, Japan

Location

Tokushima University Hospital /ID# 164145

Tokushima, Tokushima, 770-8503, Japan

Location

Juntendo University Hospital /ID# 169564

Bunkyo-ku, Tokyo, 113-8431, Japan

Location

Tokyo Medical And Dental University, Medical Hospital /ID# 165251

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Nippon Medical School Hospital /ID# 166938

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

The University of Tokyo Hospital /ID# 162943

Bunkyo-ku, Tokyo, 113-8655, Japan

Location

The Jikei University Hospital /ID# 164152

Minato-ku, Tokyo, 105-8471, Japan

Location

Tokyo Medical University Hospital /ID# 164146

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Center Hospital of the National Center for Global Health and Medicine /ID# 164148

Shinjuku-ku, Tokyo, 162-8655, Japan

Location

Tokyo Women's Medical University Hospital /ID# 165248

Shinjuku-ku, Tokyo, 162-8666, Japan

Location

Yamaguchi University Hospital /ID# 165249

Ube-shi, Yamaguchi, 755-8505, Japan

Location

Kagoshima Uni Med and Dental /ID# 164150

Kagoshima, 890-8520, Japan

Location

Kakogawa Central City Hospital /ID# 167706

Kakogawa, 489-0065, Japan

Location

Miyata Ophthalmic Hospital /ID# 167707

Miyakonojō, 885-0051, Japan

Location

Duplicate_The Hospital of Hyogo College /ID# 166913

Nishinomiya-shi, 663-8501, Japan

Location

Osaka Hospital /ID# 164151

Osaka, 572-0854, Japan

Location

Yodogawa Christian Hospital /ID# 161741

Osaka, Japan

Location

Omihachiman Community Med Ctr /ID# 164978

Ōmihachiman, 523-0082, Japan

Location

Tosei General Hospital /ID# 167708

Seto, 489-8642, Japan

Location

Natl Defense Med College Hosp /ID# 162946

Tokorozawa, 359-0042, Japan

Location

Abbott Japan /ID# 147893

Tokyo, 108-6303, Japan

Location

Tokyo Shinjuku Medical Center /ID# 166934

Tokyo, 162-8543, Japan

Location

Tottori Municipal Hospital /ID# 159431

Tottori, 680-8501, Japan

Location

Related Publications (1)

  • Namba K, Kaburaki T, Tsuruga H, Ogawa Y, Iwashita E, Goto H. Long-Term Safety and Effectiveness of Adalimumab in Japanese Patients with Noninfectious Intermediate, Posterior, or Panuveitis: Post-Marketing Surveillance of 251 Patients. Ophthalmol Ther. 2022 Jun;11(3):1147-1161. doi: 10.1007/s40123-022-00493-z. Epub 2022 Mar 19.

    PMID: 35305254DERIVED

Related Links

MeSH Terms

Conditions

Uveitis

Condition Hierarchy (Ancestors)

Uveal DiseasesEye 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

September 14, 2016

First Posted

September 27, 2016

Study Start

November 15, 2016

Primary Completion

October 14, 2020

Study Completion

October 14, 2020

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations

JP(39)