Inflammatory Bowel DiseaseNCT00586599
Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
A study testing measurement of inflammatory markers in people with Inflammatory Bowel Disease and Crohn's Disease, run by Indiana University at 1 site in United States.
Trial summary
The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- What is being tested?
- measurement of inflammatory markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Jul 2014
- 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 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children with a new diagnosis of Crohn's Disease and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
- Clinical diagnosis within the previous 21 days
- Above age 7 and younger than age 18
- Signed informed consent statement and assent statement.
- Children with a new diagnosis of Ulcerative Colitis and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
- Clinical diagnosis within the previous 21 days
Show all 21Show fewer
- Above age 7 and younger than age 18
- Signed informed consent statement and assent statement.
- Children with Crohn's Disease whose physician has initiated Infliximab treatment for the first time (10 Subjects):
- Clinical diagnosis of Crohn's Disease
- Above age 7 and younger that age 18
- Signed informed consent statement and assent statement.
- Children with Ulcerative Colitis whose physician has initiated Infliximab treatment for the first time (10 Subjects):
- Clinical diagnosis of Ulcerative Colitis
- Above age 7 and younger than age 18
- Signed informed consent statement and assent statement.
- Healthy Controls (10 Subjects):
- Above age 7 and younger than age 18
- otherwise healthy, with no intercurrent illness as determined by a member of the study team using the eligibility checklist
- controls will be gender and age (± 2 years) matched to the patient groups described above
- Signed informed consent statement and assent statement
Who cannot join
- unwilling to give consent for this study.
- child with prior prescription and administration of Infliximab
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University-Riley Hospital
Indianapolis, Indiana, 46202
About this study
The goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients. We hypothesize that the beta to alpha ratio will be higher in patients with active disease and that there will be a correlation between the ratio and the severity of disease.
- Being tested
- measurement of inflammatory markers
- Keywords
- IBD, CD, UC, Crohn's Disease, Ulcerative Colitis, Pediatric, inflammatory markers
- 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.
measurement of inflammatory markersOther
measuring inflammatory markers and comparing to controls.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Subjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms. Receives: Other: measurement of inflammatory markers |
| IBD and infliximab | Other | Subjects who have IBD and will be receiving infliximab for the first time. Receives: Other: measurement of inflammatory markers |
| Newly Diagnosed IBD | Other | Subjects who are newly diagnosed with IBD and given corticosteroid therapy. Receives: Other: measurement of inflammatory markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
This study hopes to assess the relative levels of the Stat4a and Stat4β isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, or from control patients.
Measured: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startAug 2007
- Primary completionJun 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana 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
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven J Steiner, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586599
- Sponsor's protocol ID
- 0707-69
- Other IDs
- IRB # 0707-69
- Status last verified
- Apr 2015
- First submitted
- 21 Dec 2007
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Levels of the Stat4 Alpha and Stat4 Beta Isoforms in PBMCs From Patients With Crohn's Disease and Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00586599
- Acronym / sponsor ID
- 0707-69
- Keywords
- IBD, CD, UC, Crohn's Disease, Ulcerative Colitis, Pediatric, inflammatory markers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 4 Jan 2008 (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 goal in these studies will be to assess the relative levels of the Stat4 alpha and Stat4 beta isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, celiac disease or from control patients. We hypothesize that the beta to alpha ratio will be higher in patients with active disease and that there will be a correlation between the ratio and the severity of disease.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Other: measurement of inflammatory markersSubjects who have no inflammatory disease who will be age/gender matched controls for the 2 other arms. |
| IBD and infliximab | Other | Other: measurement of inflammatory markersSubjects who have IBD and will be receiving infliximab for the first time. |
| Newly Diagnosed IBD | Other | Other: measurement of inflammatory markersSubjects who are newly diagnosed with IBD and given corticosteroid therapy. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (21 listed)
- Children with a new diagnosis of Crohn's Disease and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
- Clinical diagnosis within the previous 21 days
- Above age 7 and younger than age 18
- Signed informed consent statement and assent statement.
- Children with a new diagnosis of Ulcerative Colitis and whose physician has not yet initiated corticosteroid treatment (10 Subjects):
Key exclusion criteria (2 listed)
- unwilling to give consent for this study.
- child with prior prescription and administration of Infliximab
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 |
|---|---|---|
| measurement of inflammatory markersmeasuring inflammatory markers and comparing to controls. | Other | Control, IBD and infliximab, Newly Diagnosed IBD |
Primary outcome
This study hopes to assess the relative levels of the Stat4a and Stat4β isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, or from control patients.
Time frame: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).
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 3 Apr 2015.
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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.
Steven J Steiner, MD principal investigator
Indiana 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 measurement of inflammatory markers in people with Inflammatory Bowel Disease and Crohn's Disease, run by Indiana University at 1 site in United States.
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 21 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: finished, as of the sponsor's last update on 3 Apr 2015. 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 United States. 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 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?
This study hopes to assess the relative levels of the Stat4a and Stat4β isoforms in PBMCs from patients with Crohn's Disease, ulcerative colitis, or from control patients. (time frame: Total duration of treatment will be 20-24 weeks (Arm A and Arm B) or 50-54 weeks (Arm C/ Arm D).). 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 3 Apr 2015.