Inflammatory Bowel DiseasesNCT03204136
Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease
An observational study of Inflammatory Bowel Diseases, run by Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to 1 Dec 2019
- 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 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Inflammatory bowel disease patients who are refractory or intolerance to conventional therapy (including mesalazine, steroid, azathioprine and biological agents). Tarcolimus or methotrexate was used in these patients.
Who may be able to join
- Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents
Who cannot join
- Pregnant woman
Trial locations and contacts
1 site in 1 country.
China1 site
Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200000
Jun Shen, MD, 8613651829887, shenjun@vip.163.com
About this study
Official title: Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study
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.
- Conditions
- Inflammatory Bowel Diseases
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tarcolimus | refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission | |
| methotrexate | refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease activity assessment after one year treatment
Disease 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.
Measured: one year
Secondary outcomes (1)
The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.
The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start1 Jul 2017 (estimated)
- Primary completion1 Apr 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhanghan Dai, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China
- Investigators
- Zhihua Ran, MD, Principal investigator, Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03204136
- Sponsor's protocol ID
- shrjibdc20170401
- Status last verified
- Jun 2017
- First submitted
- 11 Jun 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tacrolimus Versus Methotrexate as Rescue Therapy for Refractory Inflammatory Bowel Disease: an Open-label, Retrospective Study
- ClinicalTrials.gov ID
- NCT03204136
- Acronym / sponsor ID
- shrjibdc20170401
- Conditions
- Inflammatory Bowel Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, ChinaOther government
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- 1 Apr 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tarcolimus | – | –refractory inflammatory bowel disease patents who used tarcolimus to induce and maintain remission |
| methotrexate | – | –refractory inflammatory bowel disease patents who used methotrexate to induce and maintain remission |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Inflammatory bowel disease patients who are refractory or intolerance to conventional therapy (including mesalazine, steroid, azathioprine and biological agents). Tarcolimus or methotrexate was used in these patients.
Key inclusion criteria (1 listed)
- Tarcolimus or methotrexate was used in refractory inflammatory bowel disease patents
Key exclusion criteria (1 listed)
- Pregnant woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease activity assessment after one year treatment
Time frame: one year
Disease 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.
1 secondary outcome
The number of participants require surgical intervention during treatment and the number of participants with treatment-related adverse events.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhihua Ran, MD principal investigator
Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health；Shanghai Inflammatory Bowel Disease Research Center；Renji Hospital, School of Medicine, Shanghai Jiao Tong University; Shanghai Institute of
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases, run by Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, China at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Shen, MD (8613651829887, shenjun@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease activity assessment after one year treatment (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jun 2017.