Crohn DiseaseEarly Phase 1NCT02956538
Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide
A Early Phase 1 study testing Thalidomide in people with Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Thalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2018
- Phase
- Early Phase 1
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-50 years old
- Diagnosis of patients with CD
- Disease in the activity: CDA Ⅰ > 150 points, endoscopic see active lesions
- Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance
Who cannot join
- Fiber stenosis caused by gastrointestinal obstruction symptoms
- Fistula exclude anal fistula
- Pregnancy or lactation
- Period of women have fertility program during the study
- Treatment not foot eight weeks after last IFX
- Central or peripheral nerve disease
Show all 10Show fewer
- Abnormal in liver and renal function
- Heart function failure
- Malignant tumor
- Active tuberculosis
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gastroenterology
Guangzhou, Guangdong, 510000
Xiang Peng, MM, 18302076916, stefaniepx@163.com
About this study
Official title: Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.
Read the detailed description
It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.
- Conditions
- Crohn Disease
- Being tested
- Thalidomide, placebo(for thalidomide)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThalidomideDrug
placebo(for thalidomide)Drug
sugar pill manufactured to mimic thalidomide 100mg tablet
| Study group | Role | What they receive |
|---|---|---|
| thalidomide | Experimental | thalidomide 100mg tablet by mouth, every night for 8 weeks Receives: Drug: Thalidomide |
| placebo | Active comparator | placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks Receives: Drug: placebo(for thalidomide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference CDAI between thalidomide group and placebo group
CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores."
Measured: 8 weeks
difference SES-CD score between thalidomide group and placebo group
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
Measured: 8weeks
Secondary outcomes (2)
difference CDAI between different thalidomide dosage group
CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores."
Measured: 1 year
difference SES-CD score between different thalidomide dosage group
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Xiang gao, MD, Study chair, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956538
- Sponsor's protocol ID
- E2016022
- Status last verified
- Nov 2016
- First submitted
- 13 Oct 2016
- Last updated
- 7 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Induced Adult Refractory Active Crohn's Disease Clinical Relieving by Using Thalidomide: A Randomized, Double-blind, Placebo-controlled Multicenter Clinical Study
- ClinicalTrials.gov ID
- NCT02956538
- Acronym / sponsor ID
- E2016022
- Conditions
- Crohn Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 7 Nov 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.
With the development and application of biological agents, the treatment effect was considerable degree improvement on refractory corn's disease. However, there are quite a part of the CD patients lost response during treatment of using response. Moreover, due to various reasons, there still a lot limited on the using of biological agents in China, that make quite a part of the refractory CD patients lack of further medical treatment options. There has been a RCT study which prove that thalidomide effect and safety on treating refractory CD or who were lost response by using biological agents in Italy, but the object of study is only limited in children and adolescents. There are some small sample studies also confirmed the efficacy and safety on refractory corn's disease by using thalidomide, but need more RCT evidence.
Detailed description
It will be divided two groups of patients by using randomized, double-blind. One group was treated by thalidomide, the other was placebo. It will be unlocked blind and analysis the effect and safety about thalidomide after 8 weeks. The second, patients still use thalidomide after unlock blind to prove its longtime treatment effect and safety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| thalidomide | Experimental | Drug: Thalidomidethalidomide 100mg tablet by mouth, every night for 8 weeks |
| placebo | Active comparator | Drug: placebo(for thalidomide)placebo (for thalidomide) 100mg tablet by mouth, every night for 8 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-50 years old
- Diagnosis of patients with CD
- Disease in the activity: CDA Ⅰ > 150 points, endoscopic see active lesions
- Refractory: immunosuppressive drugs or biological agents which are used in current treatment is invalid and/or intolerance
Key exclusion criteria (10 listed)
- Fiber stenosis caused by gastrointestinal obstruction symptoms
- Fistula exclude anal fistula
- Pregnancy or lactation
- Period of women have fertility program during the study
- Treatment not foot eight weeks after last IFX
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 |
|---|---|---|
| Thalidomide | Drug | thalidomide |
| placebo(for thalidomide)sugar pill manufactured to mimic thalidomide 100mg tablet | Drug | placebo |
Primary outcome
difference CDAI between thalidomide group and placebo group
Time frame: 8 weeks
CDAI means Crohn's Disease Activity Index.The purpose of this crohn's disease activity index (CDAI) calculator is to gauge the progress or lack of progress for people with crohn's disease. The reference article says "generally speaking, CDAI scores below 150 indicate a better prognosis than higher scores."
difference SES-CD score between thalidomide group and placebo group
Time frame: 8weeks
SES-CD means Simple endoscopic score for Crohn's disease ,which predicts long-term prognosis in Crohn's disease patients with clinical remission.
2 secondary outcomes
difference CDAI between different thalidomide dosage group
Time frame: 1 year
difference SES-CD score between different thalidomide dosage group
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2016.
- Individual participant dataSharing planned: Yes
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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.
Xiang gao, MD study chair
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Thalidomide in people with Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen 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 4 inclusion and 10 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 7 Nov 2016. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiang Peng, MM (18302076916, stefaniepx@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference CDAI between thalidomide group and placebo group (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 7 Nov 2016.