Inflammatory Bowel DiseasesSTAMPNCT03370601
Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies in Chronic Inflammatory Diseases
A study testing Infliximab, Mercaptopurine and Azathioprine in people with Inflammatory Bowel Diseases, run by University Hospital, Lille at 1 site in France.
Trial summary
This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Infliximab, Mercaptopurine and Azathioprine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2017to Jan 2019
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with ulcerative colitis or crohn's disease
- treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
- active disease ( HBI > 5 for CD patients or SCCAI> 6 for UC patients)
- patients treated with infliximab only at the time of loss of response
Who cannot join
- Patients with CD with ano perineal lesions and without luminal activity
- patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
- patients with acute severe flare (HBI>12 for CD patients and Lichtiger score > 10 for UC patients)
- pregnant female
- patients with anal disease alone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab
This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Infliximab, Mercaptopurine, Azathioprine
- Keywords
- crohn's disease, ulcerative colitis, infliximab, loss of response
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Infliximab 10mg/kg every 8 weeks
MercaptopurineDrug
Also called addition strategy with 6-mercaptopurine in second intention
6-mercaptopurine 1 à 1,5 mg/kg
AzathioprineDrug
Also called addition strategy with azathioprine in first intention
Azathioprine 2 à 2.5mg/kg/j
InfliximabDrug
Infliximab 5mg/kg every 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Optimisation strategy | Other | increase of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks Receives: Drug: Infliximab |
| Addition strategy | Other | same dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine Receives: Drug: Mercaptopurine; Drug: Azathioprine; Drug: Infliximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients in Clinical remission
the clinical remission is defined by Harvey Bradshaw (HBI) Index < 4 for Crohn's disease or Simple Clinical Colitis Activity Index (SCCAI)<4 for ulcerative colitis.
Measured: At Week 52
Secondary outcomes (7)
Number of patients in deep remission
clinical remission associated with endoscopic remission (CDEIS <3 for CD patients or Mayo score<2 for UC patients)
Measured: At Week 52
Number of patient in remission and clinical response
clinical response is defined as a decrease of at least 3 points of HBI for CD patients or SCCAI for UC patients compared to baseline (week 0).
Simple Clinical Colitis Activity Index (SCCAI)<4 for ulcerative colitisHBI pour MC et SCCAI pour RCH <4 associated at CRP < 5 mg/dl.
Measured: At week 16
infliximab blood concentration
Measured: Baseline, week 16 ad week 52
infliximab antibodies concentration
Measured: Baseline, week 16 ad week 52
economic criteria
medical fees in each arm
Measured: At week 52
number of patient with adverse effects and allergic reactions with infliximab
Measured: At week 52
Inflammatory bowel disease questionnaire (score IBDQ)
quality of life
Measured: Baseline and week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2017
- Study start3 Jan 2017
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Not enough recruitment Lack of funding CR
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benjamin Pariente, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03370601
- Sponsor's protocol ID
- 2015_23
- Other IDs
- 2015-A00940-49
- Acronym
- STAMP
- Status last verified
- Feb 2019
- First submitted
- 7 Dec 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
PubMed 40013523
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical and Immunological Impact of Two Therapeutic Strategies (Increasing the Infliximab Dose or Introduction of Immunosuppressive Therapy) in Patients Chronic Inflammatory Bowel Diseases in Loss of Response to Infliximab
- ClinicalTrials.gov ID
- NCT03370601
- Acronym / sponsor ID
- STAMP / 2015_23
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- crohn's disease, ulcerative colitis, infliximab, loss of response
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough recruitment Lack of funding CR
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 12 Dec 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.
This study evaluates 2 therapeutic strategies (increase infliximab dose or add an immunosuppressant) in patients with inflammatory bowel disease in loss of response to infliximab. Addition of an immunosuppressant may be more efficient at long term and is less expensive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optimisation strategy | Other | Drug: Infliximabincrease of Infliximab dose from 5mg/kg every 8 weeks to Infliximab 10 mg/kg every 8 weeks |
| Addition strategy | Other | Drug: Mercaptopurine, Drug: Azathioprine, Drug: Infliximabsame dose of Infliximab ( 5mg/kg every 8 weeks) with addition of immunosuppressive agent: Azathioprine or Mercaptopurine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patients with ulcerative colitis or crohn's disease
- treated with infliximab (5mg/kg per 8 weeks) and with loss of response after at least 4 infusions of infliximab
- active disease ( HBI > 5 for CD patients or SCCAI> 6 for UC patients)
- patients treated with infliximab only at the time of loss of response
Key exclusion criteria (5 listed)
- Patients with CD with ano perineal lesions and without luminal activity
- patients treated with cortico steroids and having had history of intolerance to azathioprin, 6-mercaptopurine or methotrexate
- patients with acute severe flare (HBI>12 for CD patients and Lichtiger score > 10 for UC patients)
- pregnant female
- patients with anal disease alone
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 |
|---|---|---|
| InfliximabInfliximab 10mg/kg every 8 weeks | Drug | Optimisation strategy |
| MercaptopurineAlso: addition strategy with 6-mercaptopurine in second intention6-mercaptopurine 1 à 1,5 mg/kg | Drug | Addition strategy |
| AzathioprineAlso: addition strategy with azathioprine in first intentionAzathioprine 2 à 2.5mg/kg/j | Drug | Addition strategy |
| InfliximabInfliximab 5mg/kg every 8 weeks | Drug | Addition strategy |
Primary outcome
Number of patients in Clinical remission
Time frame: At Week 52
the clinical remission is defined by Harvey Bradshaw (HBI) Index < 4 for Crohn's disease or Simple Clinical Colitis Activity Index (SCCAI)<4 for ulcerative colitis.
7 secondary outcomes
Number of patients in deep remission
Time frame: At Week 52
Number of patient in remission and clinical response
Time frame: At week 16
infliximab blood concentration
Time frame: Baseline, week 16 ad week 52
infliximab antibodies concentration
Time frame: Baseline, week 16 ad week 52
economic criteria
Time frame: At week 52
number of patient with adverse effects and allergic reactions with infliximab
Time frame: At week 52
Inflammatory bowel disease questionnaire (score IBDQ)
Time frame: Baseline and week 52
Results and safety
The study was stopped early (reason given: Not enough recruitment Lack of funding CR). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Derived from this study: PubMed 40013523Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.
- Individual participant dataSharing planned: No
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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.
Benjamin Pariente, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Infliximab, Mercaptopurine and Azathioprine in people with Inflammatory Bowel Diseases, run by University Hospital, Lille at 1 site in France.
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 5 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: stopped early, as of the sponsor's last update on 15 Feb 2019. 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 France. 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?
The study was stopped early (reason given: Not enough recruitment Lack of funding CR). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients in Clinical remission (time frame: At Week 52). 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 NCT03370601, which also lists 1 linked publication.
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 15 Feb 2019.