Crohn's DiseaseNCT01144156
Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
A study testing Treatment with Adalimumab in people with Crohn's Disease, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Treatment with Adalimumab
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- 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
- Isolated small bowel Crohn's disease.
- Age ≥18.
- Active disease (CDAI≥220).
Who cannot join
- Known fixed stricture in the small intestine.
- Former small bowel obstruction or obstructive symptoms.
- Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
- Colonic disease (except ileocecal valve area).
- Anti-TNF treatment in the last 3 months.
- Sensitivity or lack of response to previous adalimumab treatment.
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- Current gastrointestinal infection.
- History of malignant disease (except BCC of skin).
- Congestive heart failure, severe renal or hepatic dysfunction.
- Patients suffering from tuberculosis, hepatitis B or C.
- Pregnancy or unwillingness to use contraception during study period.
- Dysphagia or swallowing disorders
- Gastroparesis or severe gastrointestinal motility dysfunction.
- Patients with cardiac pacemaker or implanted cardioverter devices.
- Unable to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
The study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.
- Conditions
- Crohn's Disease
- Being tested
- Treatment with Adalimumab
- Keywords
- Crohn's disease, Small bowel, Mucosal healing, Capsule endoscopy, Adalimumab, Small bowel Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with AdalimumabDrug
Also called Humira (Abbott Laboratories)
All patients will receive SC adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg from week 4 every 2 weeks up to 12 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete mucosal healing
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
Measured: After 14 weeks of treatment
Secondary outcomes (2)
Partial mucosal healing
Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
Measured: After 14 weeks of treatment
Correlation with clinical activity
Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.
Measured: After 14 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2010 (estimated)
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 Crohn's DiseaseStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01144156
- Sponsor's protocol ID
- Gal002
- Status last verified
- May 2010
- First submitted
- 13 Jun 2010
- Last updated
- 15 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Gal E, Geller A, Fraser G, Levi Z, Niv Y. Assessment and validation of the new capsule endoscopy Crohn's disease activity index (CECDAI). Dig Dis Sci. 2008 Jul;53(7):1933-7. doi: 10.1007/s10620-007-0084-y. Epub 2007 Nov 22.
PubMed 18034304
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
- ClinicalTrials.gov ID
- NCT01144156
- Acronym / sponsor ID
- Gal002
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, Small bowel, Mucosal healing, Capsule endoscopy, Adalimumab, Small bowel Crohn's disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- First posted
- 15 Jun 2010 (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 study hypothesis is that adalimumab induces mucosal healing in the small bowel and that mucosal healing correlates with disease activity. 30 Patients with isolated active small bowel Crohn's disease which are candidates to receive anti-TNF treatment will be included in the study. All patients will undergo patency capsule examination and capsule endoscopy afterwards. Small bowel endoscopic disease severity will be assessed by the capsule endoscopy Crohn's disease activity index (CECDAI). The patients will receive Adalimumab (Humira)injections (160mg,80mg and 40mg every 2 weeks ) for 12 weeks. on week 14 a second capsule endoscopy will be performed and CECDAI calculated again. The patients clinical condition, CDAI,IBDQ and laboratory results including CRP, CBC and fecal calprotectin will be assessed on weeks o, 7 and 14 and results will be compared with the endoscopic score.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Isolated small bowel Crohn's disease.
- Age ≥18.
- Active disease (CDAI≥220).
Key exclusion criteria (15 listed)
- Known fixed stricture in the small intestine.
- Former small bowel obstruction or obstructive symptoms.
- Patients expected to undergo small bowel surgery in the near future or had intestinal surgery in the previous 6 months.
- Colonic disease (except ileocecal valve area).
- Anti-TNF treatment in the last 3 months.
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 |
|---|---|---|
| Treatment with AdalimumabAlso: Humira (Abbott Laboratories)All patients will receive SC adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg from week 4 every 2 weeks up to 12 weeks | Drug | – |
Primary outcome
Complete mucosal healing
Time frame: After 14 weeks of treatment
Complete mucosal healing of active inflammatory lesions in the small intestine, as assessed by capsule endoscopy
2 secondary outcomes
Partial mucosal healing
Time frame: After 14 weeks of treatment
Correlation with clinical activity
Time frame: After 14 weeks of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2010.
- Background: PubMed 18034304Gal E, Geller A, Fraser G, Levi Z, Niv Y. Assessment and validation of the new capsule endoscopy Crohn's disease activity index (CECDAI). Dig Dis Sci. 2008 Jul;53(7):1933-7. doi: 10.1007/s10620-007-0084-y. Epub 2007 Nov 22.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with Adalimumab in people with Crohn's Disease, run by Rabin Medical Center at 1 site in Israel.
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 15 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 15 Jun 2010. 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 Israel. 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?
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?
Complete mucosal healing (time frame: After 14 weeks of treatment). 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 NCT01144156, 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 Jun 2010.