Crohn's DiseasesNCT02675153
To Evaluate the Efficacy and Safety of Rapamycin for Crohn's Disease-related Stricture
A study testing Rapamycin in people with Crohn's Diseases, run by The Second Hospital of Nanjing Medical University at 1 site in China.
Trial summary
Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Diseases
- What is being tested?
- Rapamycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2015to Oct 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chinese patients (≥18 years of age) with a documented definite diagnosis of CD;
- the presence of a clinically symptomatic stricture;
- strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE).
Who cannot join
- Patients who were pregnant, diagnosed with intestinal perforation, complete intestinal obstruction, any signs of dysplasia or malignancy, or use of anti-tumor necrosis factor (TNF) in the last three months;
- Patients who were not followed up between the inception of medication and any other subsequent treatments.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210011
Faming Zhang, MD, PhD, 086-25-58509883, fzhang@njmu.edu.cn
About this study
Official title: Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture
Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.
Read the detailed description
Management of Crohn's disease （CD） with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.
- Conditions
- Crohn's Diseases
- Being tested
- Rapamycin
- Keywords
- rapamycin, stricture, fibrosis
- Medical subject headings
- Crohn Disease, Constriction, Pathologic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RapamycinDrug
Also called Sirolimus
Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.
| Study group | Role | What they receive |
|---|---|---|
| Upper gastrointestinal strictures | Experimental | Patients with upper gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months. Receives: Drug: Rapamycin |
| Lower gastrointestinal strictures | Experimental | Patients with lower gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months. Receives: Drug: Rapamycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response was defined as the following criteria: (a) the ability to tolerate a normal diet (vegetable fiber), with a reduction of ≥ 75% in overall baseline target score and sub-score ≤ 2 (Table S1); (b) no need for ED or surgery; (c) no severe adverse events or any other reasons leading to rapamycin withdrawal.
Measured: up to 24 weeks
Secondary outcomes (2)
Adverse events
New onset of symptoms and the exacerbation of previous symptoms were recorded as adverse events (AEs)
Measured: through study completion, an average of 3 years
The rate of surgery or ED after rapamycin
For long-term treatment outcomes, the primary endpoint was the rate of surgery or ED after rapamycin.
Measured: through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start1 Apr 2015
- Primary completionOct 2020 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faming Zhang, The Second Hospital of Nanjing Medical University
- Investigators
- Faming Zhang, MD,PhD, Principal investigator, The Second Hospital of Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675153
- Sponsor's protocol ID
- RAPA-CN-160122
- Status last verified
- Oct 2020
- First submitted
- 21 Jan 2016
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Mutalib M, Borrelli O, Blackstock S, Kiparissi F, Elawad M, Shah N, Lindley K. The use of sirolimus (rapamycin) in the management of refractory inflammatory bowel disease in children. J Crohns Colitis. 2014 Dec;8(12):1730-4. doi: 10.1016/j.crohns.2014.08.014. Epub 2014 Sep 18.
PubMed 25240477Massey DC, Bredin F, Parkes M. Use of sirolimus (rapamycin) to treat refractory Crohn's disease. Gut. 2008 Sep;57(9):1294-6. doi: 10.1136/gut.2008.157297.
PubMed 18719139
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Rapamycin in the Treatment of Crohn's Disease-related Stricture
- ClinicalTrials.gov ID
- NCT02675153
- Acronym / sponsor ID
- RAPA-CN-160122
- Conditions
- Crohn's Diseases
- Keywords
- rapamycin, stricture, fibrosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- The Second Hospital of Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2015 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 5 Feb 2016 (estimated)
- 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.
Crohn's disease （CD） with stenosis has limited therapeutic options and with high surgical rate. The present clinical trial aims to evaluate the efficacy and safety of rapamycin in the treatment of stricturing Crohn's Disease.
Detailed description
Management of Crohn's disease （CD） with stenosis is challenging and often requires endoscopic dilatation or surgical resection of the strictured bowel. Sirolimus (rapamycin), a macrocyclic antibiotic with immunosuppressive and antineoplastic properties, has been reported as promising rescue therapy for refractory CD. This study aims to evaluate the use of sirolimus for stricturing Crohn's Disease. Patients in this study will receive a continuous dosing schedule of oral sirolimus 2mg daily for six months. Clinical responses were defined as the ability to tolerate the regular diet with vegetable fiber combined with a reduction of ≥ 75% in overall target score and a score of less than two points for each item.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper gastrointestinal strictures | Experimental | Drug: RapamycinPatients with upper gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months. |
| Lower gastrointestinal strictures | Experimental | Drug: RapamycinPatients with lower gastrointestinal strictures were treated with rapamycin (2mg/day, Sirolimus, Roche) for at least six months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chinese patients (≥18 years of age) with a documented definite diagnosis of CD;
- the presence of a clinically symptomatic stricture;
- strictures confirmed by endoscopy (passage of the endoscope with resistance or not traversable) or imaging (CT enterography (CTE) or MR enterography (MRE).
Key exclusion criteria (2 listed)
- Patients who were pregnant, diagnosed with intestinal perforation, complete intestinal obstruction, any signs of dysplasia or malignancy, or use of anti-tumor necrosis factor (TNF) in the last three months;
- Patients who were not followed up between the inception of medication and any other subsequent treatments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RapamycinAlso: SirolimusParticipants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months. | Drug | Lower gastrointestinal strictures, Upper gastrointestinal strictures |
Primary outcome
Response rate
Time frame: up to 24 weeks
Response was defined as the following criteria: (a) the ability to tolerate a normal diet (vegetable fiber), with a reduction of ≥ 75% in overall baseline target score and sub-score ≤ 2 (Table S1); (b) no need for ED or surgery; (c) no severe adverse events or any other reasons leading to rapamycin withdrawal.
2 secondary outcomes
Adverse events
Time frame: through study completion, an average of 3 years
The rate of surgery or ED after rapamycin
Time frame: through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.
- Background: PubMed 25240477Mutalib M, Borrelli O, Blackstock S, Kiparissi F, Elawad M, Shah N, Lindley K. The use of sirolimus (rapamycin) in the management of refractory inflammatory bowel disease in children. J Crohns Colitis. 2014 Dec;8(12):1730-4. doi: 10.1016/j.crohns.2014.08.014. Epub 2014 Sep 18.
- Background: PubMed 18719139Massey DC, Bredin F, Parkes M. Use of sirolimus (rapamycin) to treat refractory Crohn's disease. Gut. 2008 Sep;57(9):1294-6. doi: 10.1136/gut.2008.157297.
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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.
Faming Zhang, MD,PhD principal investigator
The Second Hospital of Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapamycin in people with Crohn's Diseases, run by The Second Hospital of Nanjing Medical University 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 3 inclusion and 2 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 8 Oct 2020. 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 Faming Zhang, MD,PhD (086-25-58509883, fzhang@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: up to 24 weeks). 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 NCT02675153, which also lists 2 linked publications.
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 8 Oct 2020.