Crohn's DiseasePhase 4TISKidsNCT02517684
Top-down Infliximab Study in Kids With Crohn's Disease
A Phase 4 study testing Infliximab, Prednisolone and Exclusive enteral nutrition in people with Crohn's Disease, run by Erasmus Medical Center at 13 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in… Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Infliximab, Prednisolone and Exclusive enteral nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 13 sitesin 3 countries
- Study dates
- Apr 2015to Jan 2024
- Phase
- Phase 4
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (age 3-17 years, both male and female, weight >10kg) with new-onset,
- untreated CD with moderate-to-severe disease activity assessed by a wPCDAI >40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria
Who cannot join
- Patients with the following characteristics will be excluded:
- immediate need for surgery,
- symptomatic stenosis or stricture in the bowel due to scarring,
- active perianal fistulas,
- severe co-morbidity,
- severe infection such as sepsis or opportunistic infections,
Show all 12Show fewer
- positive stool culture,
- positive Clostridium difficile assay,
- positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy,
- those already started with CD specific therapy,
- patients with a suspected or
- definitive pregnancy
Trial locations and contacts
13 sites in 3 countries.
13 sites in 3 countries
Netherlands10 sites
Academic Medical Center
Amsterdam
VU University Medical Center
Amsterdam
Amphia Hospital
Breda
Medisch Spectrum Twente
Enschede
Leiden University Medical Center
Leiden
Radboud University Medical Center
Nijmegen
Erasmus Medical Center
Rotterdam, South Holland, 3000 CA
Maasstad Hospital
Rotterdam
University Medical Center Utrecht
Utrecht
Isala hospital
Zwolle
Belgium2 sites
University Hospital Brussels
Brussels
University Hospitals Leuven
Leuven
About this study
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
Read the detailed description
Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing IFX and AZA at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or EEN and AZA, in moderate-to-severe pediatric CD patients.
Sample size: We will include 100 (2 x 50) patients. With these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05).
Study design: an international open-label randomised controlled trial Study population: Children (age 3-17 yrs) with new-onset, untreated, CD with moderate-to-severe disease activity (weighted Pediatric CD Index [wPCDAI] >40) Intervention: Patients will be randomised to either top-down or conventional step-up treatment.
Treatment arm 1: Top-down IFX treatment will consist of a total of 5 IFX infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral AZA 2-3 mg/kg once daily. AZA therapy will continue after the last IFX infusion to maintain remission.
Treatment arm 2: Step-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.
Main study parameters/endpoints: Clinical remission at 52 weeks without need for additional CD related therapy or surgery. Secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth, quality of life and adverse events.
- Conditions
- Crohn's Disease
- Being tested
- Infliximab, Prednisolone, Exclusive enteral nutrition, Azathioprine
- Keywords
- Crohn's disease, pediatric, infliximab, top-down, TISKids
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InfliximabDrug
Also called Inflectra
PrednisoloneDrug
Exclusive enteral nutritionOther
AzathioprineDrug
Also called Imuran
| Study group | Role | What they receive |
|---|---|---|
| Top-down | Experimental | Infliximab and azathioprine; patients will receive 5 infliximab infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks). IFX will be discontinued after 5 IFX infusions. Patients will also receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment. Receives: Drug: Infliximab; Drug: Azathioprine |
| Step-up | Active comparator | Step-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment. Receives: Drug: Prednisolone; Other: Exclusive enteral nutrition; Drug: Azathioprine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission without need for additional CD related therapy or surgery
Clinical remission is defined as a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 12.5 points
Measured: 52 weeks
Secondary outcomes (14)
Clinical response rates
Response is defined by a decrease in wPCDAI score above 17.5 points compared to baseline
Measured: 10 weeks
Clinical remission rates
Remission is wPCDAI<12.5
Measured: 10 and 52 weeks
Mucosal healing
Assessed by endoscopy (SES-CD) and/or fecal calprotectin (<100microgram/gram)
Measured: 10 and 52 weeks
Change in height Z-scores
Measured: 10 and 52 weeks
Change in BMI Z-scores
Measured: 10 and 52 weeks
Change bone age
Measured: 10 and 52 weeks
Change in Tanner stage
Measured: 10 and 52 weeks
Therapy failure rates over time
Therapy failure: primary non-response, loss of response according to wPCDAI and medication intolerance
Measured: 52 weeks
Adverse events rates
Adverse events includes therapy side effects, disease complications (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)
Measured: 52 weeks, and 260 weeks
Cumulative therapy use
Measured: 52 weeks, and 260 weeks
Long-term yearly remission rates without need for additional CD related therapy or surgery
Clinical remission is defined as a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 12.5 points
Measured: 260 weeks
Long-term yearly number of flares
Measured: 260 weeks
Long-term yearly clinical remission rates
Clinical remission is defined as a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 12.5 points
Measured: 260 weeks
Long-term yearly mucosal healing (calprotectin) rates
fecal calprotectin <100microgram/gram
Measured: 260 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startApr 2015
- Primary completionDec 2019
- Study completionJan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Hospira, now a wholly owned subsidiary of Pfizer
- Responsible party
- Principal investigator, Lissy de Ridder, Erasmus Medical Center
- Investigators
- Lissy de Ridder, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517684
- Sponsor's protocol ID
- NL52030.078.15
- Other IDs
- 2014-005702-37, MEC-2015-080, 2014
- Acronym
- TISKids
- Status last verified
- Mar 2024
- First submitted
- 1 Jul 2015
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Vuijk SA, Jongsma MME, Cozijnsen MA, van Pieterson M, de Meij TGJ, Groeneweg M, Wolters VM, van Wering H, Hojsak I, Kolho KL, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg-Roord S, Pruijsen-Nienhuis JM, Rizopoulos D, Escher JC, Samsom JN, de Ridder L. Randomized Trial Comparing 5-Year Follow-Up of First-Line Infliximab to Conventional Therapy in Pediatric Crohn's Disease. Clin Gastroenterol Hepatol. 2026 Jul 4:S1542-3565(26)00488-X. doi: 10.1016/j.cgh.2026.06.029. Online ahead of print.
PubMed 42401249Vuijk SA, Jongsma MME, Hoeven BM, Cozijnsen MA, van Pieterson M, de Meij TGJ, Norbruis OF, Groeneweg M, Wolters VM, van Wering H, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg S, Rizopoulos D, Poley MJ, Escher JC, de Ridder L. Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease. Aliment Pharmacol Ther. 2024 Jun;59(12):1510-1520. doi: 10.1111/apt.18000. Epub 2024 Apr 21.
PubMed 38644588Jongsma MME, Costes LMM, Tindemans I, Cozijnsen MA, Raatgreep RHC, van Pieterson M, Li Y, Escher JC, de Ridder L, Samsom JN. Serum Immune Profiling in Paediatric Crohn's Disease Demonstrates Stronger Immune Modulation With First-Line Infliximab Than Conventional Therapy and Pre-Treatment Profiles Predict Clinical Response to Both Treatments. J Crohns Colitis. 2023 Aug 21;17(8):1262-1277. doi: 10.1093/ecco-jcc/jjad049.
PubMed 36934327Jongsma MME, Aardoom MA, Cozijnsen MA, van Pieterson M, de Meij T, Groeneweg M, Norbruis OF, Wolters VM, van Wering HM, Hojsak I, Kolho KL, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg-Roord STA, Schreurs MWJ, Rizopoulos D, Doukas M, Escher JC, Samsom JN, de Ridder L. First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial. Gut. 2022 Jan;71(1):34-42. doi: 10.1136/gutjnl-2020-322339. Epub 2020 Dec 31.
PubMed 33384335Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol. 2016 Dec 22;3(1):e000123. doi: 10.1136/bmjgast-2016-000123. eCollection 2016.
PubMed 28090335
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Top-down Infliximab Study in Kids With Crohn's Disease
- ClinicalTrials.gov ID
- NCT02517684
- Acronym / sponsor ID
- TISKids / NL52030.078.15
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, pediatric, infliximab, top-down, TISKids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development, Hospira, now a wholly owned subsidiary of Pfizer
- Study start
- Apr 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2024 (actual)
- First posted
- 7 Aug 2015 (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.
The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
Detailed description
Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing IFX and AZA at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or EEN and AZA, in moderate-to-severe pediatric CD patients.
Sample size: We will include 100 (2 x 50) patients. With these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided α 0.05).
Study design: an international open-label randomised controlled trial Study population: Children (age 3-17 yrs) with new-onset, untreated, CD with moderate-to-severe disease activity (weighted Pediatric CD Index [wPCDAI] >40) Intervention: Patients will be randomised to either top-down or conventional step-up treatment.
Treatment arm 1: Top-down IFX treatment will consist of a total of 5 IFX infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral AZA 2-3 mg/kg once daily. AZA therapy will continue after the last IFX infusion to maintain remission.
Treatment arm 2: Step-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.
Main study parameters/endpoints: Clinical remission at 52 weeks without need for additional CD related therapy or surgery. Secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth, quality of life and adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Top-down | Experimental | Drug: Infliximab, Drug: AzathioprineInfliximab and azathioprine; patients will receive 5 infliximab infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks). IFX will be discontinued after 5 IFX infusions. Patients will also receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment. |
| Step-up | Active comparator | Drug: Prednisolone, Other: Exclusive enteral nutrition, Drug: AzathioprineStep-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children (age 3-17 years, both male and female, weight >10kg) with new-onset,
- untreated CD with moderate-to-severe disease activity assessed by a wPCDAI >40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria
Key exclusion criteria (12 listed)
- immediate need for surgery,
- symptomatic stenosis or stricture in the bowel due to scarring,
- active perianal fistulas,
- severe co-morbidity,
- severe infection such as sepsis or opportunistic infections,
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 |
|---|---|---|
| InfliximabAlso: Inflectra | Drug | Top-down |
| Prednisolone | Drug | Step-up |
| Exclusive enteral nutrition | Other | Step-up |
| AzathioprineAlso: Imuran | Drug | Step-up, Top-down |
Primary outcome
Clinical remission without need for additional CD related therapy or surgery
Time frame: 52 weeks
Clinical remission is defined as a weighted Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 12.5 points
14 secondary outcomes
Clinical response rates
Time frame: 10 weeks
Clinical remission rates
Time frame: 10 and 52 weeks
Mucosal healing
Time frame: 10 and 52 weeks
Change in height Z-scores
Time frame: 10 and 52 weeks
Change in BMI Z-scores
Time frame: 10 and 52 weeks
Change bone age
Time frame: 10 and 52 weeks
Change in Tanner stage
Time frame: 10 and 52 weeks
Therapy failure rates over time
Time frame: 52 weeks
Adverse events rates
Time frame: 52 weeks, and 260 weeks
Cumulative therapy use
Time frame: 52 weeks, and 260 weeks
Long-term yearly remission rates without need for additional CD related therapy or surgery
Time frame: 260 weeks
Long-term yearly number of flares
Time frame: 260 weeks
Long-term yearly clinical remission rates
Time frame: 260 weeks
Long-term yearly mucosal healing (calprotectin) rates
Time frame: 260 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 42401249Vuijk SA, Jongsma MME, Cozijnsen MA, van Pieterson M, de Meij TGJ, Groeneweg M, Wolters VM, van Wering H, Hojsak I, Kolho KL, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg-Roord S, Pruijsen-Nienhuis JM, Rizopoulos D, Escher JC, Samsom JN, de Ridder L. Randomized Trial Comparing 5-Year Follow-Up of First-Line Infliximab to Conventional Therapy in Pediatric Crohn's Disease. Clin Gastroenterol Hepatol. 2026 Jul 4:S1542-3565(26)00488-X. doi: 10.1016/j.cgh.2026.06.029. Online ahead of print.
- Derived from this study: PubMed 38644588Vuijk SA, Jongsma MME, Hoeven BM, Cozijnsen MA, van Pieterson M, de Meij TGJ, Norbruis OF, Groeneweg M, Wolters VM, van Wering H, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg S, Rizopoulos D, Poley MJ, Escher JC, de Ridder L. Randomised clinical trial: First-line infliximab biosimilar is cost-effective compared to conventional treatment in paediatric Crohn's disease. Aliment Pharmacol Ther. 2024 Jun;59(12):1510-1520. doi: 10.1111/apt.18000. Epub 2024 Apr 21.
- Derived from this study: PubMed 36934327Jongsma MME, Costes LMM, Tindemans I, Cozijnsen MA, Raatgreep RHC, van Pieterson M, Li Y, Escher JC, de Ridder L, Samsom JN. Serum Immune Profiling in Paediatric Crohn's Disease Demonstrates Stronger Immune Modulation With First-Line Infliximab Than Conventional Therapy and Pre-Treatment Profiles Predict Clinical Response to Both Treatments. J Crohns Colitis. 2023 Aug 21;17(8):1262-1277. doi: 10.1093/ecco-jcc/jjad049.
- Derived from this study: PubMed 33384335Jongsma MME, Aardoom MA, Cozijnsen MA, van Pieterson M, de Meij T, Groeneweg M, Norbruis OF, Wolters VM, van Wering HM, Hojsak I, Kolho KL, Hummel T, Stapelbroek J, van der Feen C, van Rheenen PF, van Wijk MP, Teklenburg-Roord STA, Schreurs MWJ, Rizopoulos D, Doukas M, Escher JC, Samsom JN, de Ridder L. First-line treatment with infliximab versus conventional treatment in children with newly diagnosed moderate-to-severe Crohn's disease: an open-label multicentre randomised controlled trial. Gut. 2022 Jan;71(1):34-42. doi: 10.1136/gutjnl-2020-322339. Epub 2020 Dec 31.
- Derived from this study: PubMed 28090335Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol. 2016 Dec 22;3(1):e000123. doi: 10.1136/bmjgast-2016-000123. eCollection 2016.
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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.
Lissy de Ridder, MD PhD principal investigator
Erasmus Medical Center
13 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Infliximab, Prednisolone and Exclusive enteral nutrition in people with Crohn's Disease, run by Erasmus Medical Center at 13 sites in 3 countries.
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 2 inclusion and 12 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: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Netherlands, Belgium, Finland. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical remission without need for additional CD related therapy or surgery (time frame: 52 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 NCT02517684, which also lists 5 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 5 Mar 2024.