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UveitisNCT02916017

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

An observational study of Uveitis, run by AbbVie at 39 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 0 to 100 years
Conditions the study is for
Uveitis
How many people
259 participants
Where
39 sitesJapan
Study dates
15 Nov 2016to 14 Oct 2020
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: Participants with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

Who may be able to join

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

Who cannot join

  • Participants previously treated with adalimumab

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Japan39 sites

  • Juntendo University Hospital /ID# 169564

    Bunkyo-ku, Tokyo, 113-8431

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

    Bunkyo-ku, Tokyo, 113-8519

  • Nippon Medical School Hospital /ID# 166938

    Bunkyo-ku, Tokyo, 113-8603

  • The University of Tokyo Hospital /ID# 162943

    Bunkyo-ku, Tokyo, 113-8655

  • Kyushu University Hospital /ID# 163042

    Fukuoka, Fukuoka, 812-8582

  • Fukuoka University Hospital /ID# 163043

    Fukuoka, Fukuoka, 814-0180

  • Hiroshima University Hospital /ID# 166915

    Hiroshima, Hiroshima, 734-8551

  • Saitama Medical University Hospital /ID# 162944

    Iruma-gun, Saitama, 350-0451

  • Kagoshima Uni Med and Dental /ID# 164150

    Kagoshima, 890-8520

  • Kakogawa Central City Hospital /ID# 167706

    Kakogawa, 489-0065

  • Duplicate_Kanazawa University Hospital /ID# 166914

    Kanazawa, Ishikawa-ken, 920-8641

  • Kobe University Hospital /ID# 165250

    Kobe, Hyōgo, 650-0017

  • Kurume University Hospital /ID# 162945

    Kurume-shi, Fukuoka, 830-0011

  • Gunma University Hospital /ID# 166916

    Maebashi, Gunma, 371-8511

  • Shinshu University Hospital /ID# 164153

    Matsumoto-shi, Nagano, 390-8621

  • Matsuyama Red Cross Hospital /ID# 164149

    Matsuyama, Ehime, 790-0826

  • The Jikei University Hospital /ID# 164152

    Minato-ku, Tokyo, 105-8471

  • Miyata Ophthalmic Hospital /ID# 167707

    Miyakonojō, 885-0051

  • Kochi Medical School Hospital /ID# 164144

    Nankoku-shi, Kochi, 783-8505

  • Niigata University Medical & Dental Hospital /ID# 169563

    Niigata, Niigata, 951-8520

  • Duplicate_The Hospital of Hyogo College /ID# 166913

    Nishinomiya-shi, 663-8501

  • Omihachiman Community Med Ctr /ID# 164978

    Ōmihachiman, 523-0082

  • Osaka Hospital /ID# 164151

    Osaka, 572-0854

  • Yodogawa Christian Hospital /ID# 161741

    Osaka

  • Hokkaido University Hospital /ID# 163041

    Sapporo, Hokkaido, 060-8648

  • Tosei General Hospital /ID# 167708

    Seto, 489-8642

  • Dokkyo Medical University Hospital /ID# 164154

    Shimotsuga-gun, Tochigi, 321-0293

  • Tokyo Medical University Hospital /ID# 164146

    Shinjuku-ku, Tokyo, 160-0023

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

    Shinjuku-ku, Tokyo, 162-8655

  • Tokyo Women's Medical University Hospital /ID# 165248

    Shinjuku-ku, Tokyo, 162-8666

  • Osaka University Hospital /ID# 164147

    Suita-shi, Osaka, 565-0871

  • Natl Defense Med College Hosp /ID# 162946

    Tokorozawa, 359-0042

  • Tokushima University Hospital /ID# 164145

    Tokushima, Tokushima, 770-8503

  • Abbott Japan /ID# 147893

    Tokyo, 108-6303

  • Tokyo Shinjuku Medical Center /ID# 166934

    Tokyo, 162-8543

  • Tottori Municipal Hospital /ID# 159431

    Tottori, 680-8501

  • Yamaguchi University Hospital /ID# 165249

    Ube-shi, Yamaguchi, 755-8505

  • Juntendo University Urayasu Hospital /ID# 168358

    Urayasu-shi, Chiba, 279-0021

  • Yokohama Municipal Citizen's Hospital /ID# 161742

    Yokohama, Kanagawa, 240-8555

Other trials in Japan

About this study

Official title: 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.

Conditions
Uveitis
Keywords
Humira, Adalimumab, Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Medical subject headings
Uveitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02916017
Study groupRoleWhat they receive
Participants receiving adalimumabParticipants receiving adalimumab for the treatment of Non-infectious Intermediate-, Posterior-, or Pan-uveitis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse drug reactions (ADR)

    ADR is the causal relationship between adalimumab and adverse events.

    Measured: Up to Week 52

Secondary outcomes (7)

  1. Change in Visual Functioning Questionnaire (VFQ)-25 score

    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.

    Measured: From Week 0 (baseline) to Week 52

  2. Change in Visual acuity in each eye

    Visual acuity change is assessed.

    Measured: From Week 0 (baseline) to Week 52

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

    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.

    Measured: From Week 0 (baseline) to Week 52

  4. Percentage of Overall improvement

    This is assessed by physicians.

    Measured: Up to Week 52

  5. Change in retinal lesions in each eye

    The change in retinal lesion are assessed.

    Measured: From Week 0 (baseline) to Week 52

  6. Change in central retinal thickness in each eye

    This is assessed by Optical Coherence Tomography (OCT)

    Measured: From Week 0 (baseline) to Week 52

  7. Change in Vitreous Haze grade in each eye

    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.

    Measured: From Week 0 (baseline) to Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2016 (estimated)
  2. Study start15 Nov 2016
  3. Primary completion14 Oct 2020
  4. Study completion14 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
259 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02916017
Sponsor's protocol ID
P15-665
Status last verified
Oct 2021
First submitted
14 Sep 2016
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 35305254

Questions about this trial

What is this clinical trial studying?

An observational study of Uveitis, run by AbbVie at 39 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse drug reactions (ADR) (time frame: Up to Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02916017, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.

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