Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy
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|ClinicalTrials.gov Identifier: NCT01144156|
Recruitment Status : Unknown
Verified May 2010 by Rabin Medical Center.
Recruitment status was: Not yet recruiting
First Posted : June 15, 2010
Last Update Posted : June 15, 2010
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: Treatment with Adalimumab||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Small Bowel Mucosal Healing Induced by Adalimumab in Crohn's Disease Patients as Assessed by Capsule Endoscopy|
- Drug: Treatment with Adalimumab
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 weeksOther Name: Humira (Abbott Laboratories)
- 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
- Partial mucosal healing [ Time Frame: After 14 weeks of treatment ]Reduction of at least 50% in the Capsule Endoscopy Crohn's Disease Activity Index (CECDAI) after treatment.
- Correlation with clinical activity [ Time Frame: After 14 weeks of treatment ]Statistical correlation between CECDAI reduction and reduction in clinical (CDAI, IBDQ) and laboratory (CRP, calprotectin etc.) indices of disease activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144156
|Rabin Medical Center - Beilinson Hospital|
|Petach Tikva, Israel, 4910|