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Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study)

Patient registry of inflammatory bowel disease to investigate the clinical course and predictors of treatment outcomes : A multicenter observational study (INSIGHT study) - INSIGHT study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000058147
Enrollment
10000
Registered
2025-06-20
Start date
2023-12-31
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory bowel disease

Interventions

None listed

Sponsors

Nagoya University
Lead Sponsor
Department of Endoscopy, TOYOTA Memorial Hospital, 1-1 Heiwa-cho, Toyota-shi, Aichi, Japan Department of Gastroenterology and Hepatology, Ichinomiya Municipal Hospital, 2-2-22 Bunkyo, Ichinomiya, Japan Department of Gastroenterology, National Hospital Organization Nagoya Medical Center, 4-1-1 Sannomaru, Naka-ku, Nagoya, Japan Department of Gastroenterology, Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital, 3-35 Michishita-cho Nakamura-ku Nagoya, Japan Department of Gastroenter
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: [New onset group] Meet all of the following (1) to (3) (1) Cases newly diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) at Nagoya University Hospital or any research institute after January 1, 2013 (2) Age 18 or older at the time of new onset (3) Gender does not matter. [New treatment group] (1) Patients who started treatment with tacrolimus, infliximab, adalimumab, golimumab, tofacitinib, vedolizumab, cyclosporine, ustekinumab, cytapheresis, steroids, azathioprine, 5-ASA, local therapy, filgotinib, upadacitinib, mikilizumab, carotegrast methyl, risankizumab, zentacort, colletiment, osamonide, or guselkumab at Nagoya University Hospital or any research institute on or after January 1, 2013. (2) Patients must be 18 years of age or older at the time of starting new treatment. (3) Gender does not matter. [Postoperative follow-up group] Meet all of the following (1) to (3) (1) Patients who underwent surgical treatment for inflammatory bowel disease at Nagoya University Hospital or at each research institute during the study period from January 1, 2013 onwards (2) Patients must be aged 18 or older at the time of surgical treatment. (3) Gender does not matter. [Endoscopy group] Meet all of the following (1) to (3) (1) Patients who underwent endoscopic examination for inflammatory bowel disease at Nagoya University Hospital or at each research institute during the study period from January 1, 2013 onwards (2) Patients must be aged 18 or older at the time of endoscopic examination. (3) Gender does not matter.

Exclusion criteria

Exclusion criteria: [New onset group] -None [New treatment introduction group] -None [Postoperative follow-up observation group] -None [Endoscopy group] -None

Design outcomes

Primary

MeasureTime frame
Efficacy rates of newly introduced drugs in the short term (2 weeks and 2 months), mid-term (3 months and 6 months), and long term (1 year, 3 years, and 5 years), treatment continuation rates, and factors correlated with these

Secondary

MeasureTime frame
Rates of new treatment introduction, hospitalization, and surgery in newly diagnosed cases, and factors correlating with them Relapse and reoperation rates in postoperative cases, and factors correlating with them Efficacy rates, endoscopic improvement rates, and continuation rates of 1st-line, 2nd-line, and 3rd-line treatments, and factors correlating with them Endoscopic remission achievement rate, treatment continuation rate, hospitalization rate, and surgery rate for 2nd-line treatment in cases who achieved clinical remission with 1st-line treatment Efficacy of anti-TNF antibody preparations, IL12/23 (23) antibody preparations, and JAK inhibitors in cases with a history of anti-TNF antibody treatment, and efficacy after anti-TNF treatment and molecular targeted drug treatment Comparison with cases without treatment Efficacy of anti-TNF antibody preparations and IL12/23 (23) antibody preparations in cases with a history of IL12/23 (23) antibody preparation treatment, comparison with cases after anti-TNF treatment and without molecular targeted drug treatment Efficacy of anti-TNF antibody preparations and IL12/23 (23) antibody preparations in cases with a history of JAK treatment, comparison with cases without molecular targeted drug treatment Efficacy of anti-TNF antibody preparations, IL12/23 (23) antibody preparations, and JAK inhibitors in cases with a history of VDZ treatment, comparison with cases without molecular targeted drug treatment Endoscopic findings, scores, and clinical factors correlated with prognosis

Countries

Japan

Contacts

Public ContactTsunaki Sawada

Nagoya University Hospitao Department of Endoscopy

sawada.tsunaki.d5@f.mail.nagoya-u.ac.jp09035532957

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026