Clinical trial NCT02916017: HUMIRA® Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Official title: HUMIRA® Special Investigation (Long-term Treatment in Patients With Non-infectious Intermediate-, Posterior-, or Pan-uveitis)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Uveitis
Keywords: Humira
Adalimumab
Non-infectious Intermediate-, Posterior-, or Pan-uveitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-09-27
Enrollment: 259
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with Non-infectious Intermediate-, Posterior-, or Pan-uveitis

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Participants previously treated with adalimumab

Primary outcomes:
measure: Incidence of adverse drug reactions (ADR)
timeFrame: Up to Week 52
Secondary outcomes:
measure: Change in Visual Functioning Questionnaire (VFQ)-25 score
timeFrame: From Week 0 (baseline) to Week 52
measure: Change in Visual acuity in each eye
timeFrame: From Week 0 (baseline) to Week 52
measure: Change in Anterior Chamber (AC) cell grade (standardization of uveitis nomenclature (SUN) criteria) in each eye
timeFrame: From Week 0 (baseline) to Week 52
measure: Percentage of Overall improvement
timeFrame: Up to Week 52
measure: Change in retinal lesions in each eye
timeFrame: From Week 0 (baseline) to Week 52
measure: Change in central retinal thickness in each eye
timeFrame: From Week 0 (baseline) to Week 52
measure: Change in Vitreous Haze grade in each eye
timeFrame: From Week 0 (baseline) to Week 52
Other outcomes:
Locations:
city: Urayasu-shi
country: Japan
facility: Juntendo University Urayasu Hospital /ID# 168358
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 164149
state: Ehime
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 163042
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Fukuoka University Hospital /ID# 163043
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 162945
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Gunma University Hospital /ID# 166916
state: Gunma
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 166915
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital /ID# 163041
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 165250
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Duplicate_Kanazawa University Hospital /ID# 166914
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 161742
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Kochi Medical School Hospital /ID# 164144
state: Kochi
city: Matsumoto-shi
country: Japan
facility: Shinshu University Hospital /ID# 164153
state: Nagano
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 169563
state: Niigata
city: Suita-shi
country: Japan
facility: Osaka University Hospital /ID# 164147
state: Osaka
city: Iruma-gun
country: Japan
facility: Saitama Medical University Hospital /ID# 162944
state: Saitama
city: Shimotsuga-gun
country: Japan
facility: Dokkyo Medical University Hospital /ID# 164154
state: Tochigi
city: Tokushima-shi
country: Japan
facility: Tokushima University Hospital /ID# 164145
state: Tokushima
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 169564
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University, Medical Hospital /ID# 165251
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Nippon Medical School Hospital /ID# 166938
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: The University of Tokyo Hospital /ID# 162943
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 164152
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 164146
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Center Hospital of the National Center for Global Health and Medicine /ID# 164148
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 165248
state: Tokyo
city: Ube-shi
country: Japan
facility: Yamaguchi University Hospital /ID# 165249
state: Yamaguchi
city: Kagoshima
country: Japan
facility: Kagoshima Uni Med and Dental /ID# 164150
city: Kakogawa
country: Japan
facility: Kakogawa Central City Hospital /ID# 167706
city: Miyakonojo
country: Japan
facility: Miyata Ophthalmic Hospital /ID# 167707
city: Nishinomiya-shi
country: Japan
facility: Duplicate_The Hospital of Hyogo College /ID# 166913
city: Omihachiman
country: Japan
facility: Omihachiman Community Med Ctr /ID# 164978
city: Osaka-shi
country: Japan
facility: Yodogawa Christian Hospital /ID# 161741
city: Osaka
country: Japan
facility: Osaka Hospital /ID# 164151
city: Seto
country: Japan
facility: Tosei General Hospital /ID# 167708
city: Tokorozawa
country: Japan
facility: Natl Defense Med College Hosp /ID# 162946
city: Tokyo
country: Japan
facility: Abbott Japan /ID# 147893
city: Tokyo
country: Japan
facility: Tokyo Shinjuku Medical Center /ID# 166934
city: Tottori
country: Japan
facility: Tottori Municipal Hospital /ID# 159431
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.