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Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease

Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03204136
Enrollment
60
Registered
2017-06-29
Start date
2017-07-01
Completion date
2019-12-01
Last updated
2017-06-29

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

Conditions

Inflammatory Bowel Diseases

Brief summary

Mesalazine, steroid, immunosuppressants and biologic agents are main medical treatments in treating inflammatory bowel diseases. Yet some patients develop severe side effects or initial invalid to conventional therapies. Some studies have already showed that tarcolimus and methotrexate are both effective in inducing and maintaining disease remission. Here we conduct a retrospective study to compare the efficancy of tarcolimus and methotrexate in treating refractory inflammatory bowel diseases as rescue therapy.

Interventions

None listed

Sponsors

Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents

Exclusion criteria

* Pregnant woman

Design outcomes

Primary

MeasureTime frameDescription
disease activity assessment after one year treatmentone yearDisease activity is assessed through blood test, radiology and clinical for both Crohn's disease and ulverative colitis. We evaluate clinical response based on Crohn's disease activity index (CDAI) for CD and Mayo score for UC at the end of one year observation.

Secondary

MeasureTime frameDescription
The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.one yearThe number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Countries

China

Contacts

Primary ContactJun Shen, MD
shenjun@vip.163.com8613651829887

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026