Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
Hali
Wadhamini
Oregon Health and Science University
Washirika
Centocor, Inc.
JARIBIO LA KLINIKI: NCT01266785
BioSeek: NCT01266785
Maneno muhimu
Kikemikali
Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract. Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It is a lifelong disease with frequent flares during the course of the disease. Crohn's disease is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication for treating severe Crohn's disease. This medicine is effective by blocking special substance (tumor necrosis factor) released from certain white blood cells in the body. Infliximab is given via a vessel at week 0, 2, 6 initially, then every 2 monthly for maintenance. However, some of patients with Crohn's disease do not respond infliximab. Currently there is no test to reveal which patients will respond to treatment. This study aims to analyze and compare particular subgroup of white cells and its products during and after infliximab treatment which may determine the responsiveness to infliximab treatment.
Maelezo
All patients will have chest x-ray and pregnancy test (if female) prior to infliximab treatment.
There will be total 5 study visits. At each visit, body weight will be measured, abdominal exam will be performed , 2 tablespoonful of blood will be drawn, stool will be collected, a questionnaire will be completed.
Tarehe
| Imethibitishwa Mwisho: | 04/30/2019 |
| Iliyowasilishwa Kwanza: | 12/22/2010 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 12/22/2010 |
| Iliyotumwa Kwanza: | 12/23/2010 |
| Sasisho la Mwisho Liliwasilishwa: | 05/05/2019 |
| Sasisho la Mwisho Lilichapishwa: | 05/07/2019 |
| Tarehe halisi ya kuanza kwa masomo: | 11/30/2010 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 06/30/2012 |
| Tarehe ya Kukamilisha Utafiti: | 06/30/2012 |
Hali au ugonjwa
Crohn's Disease
Uingiliaji / matibabu
Drug: Infliximab
Awamu
-
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 18 Years Kwa 18 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Newly diagnosed or exacerbating CD (Moderate to severe CD). - The diagnosis of moderate to severe CD will be confirmed by previous endoscopy and biopsy. - Have the capacity to understand and sign an informed consent form. |
Matokeo
Hatua za Matokeo ya Msingi
1. Changes of IL-2 and Treg cell levels [1 year]
To determine if the change of IL-2 and Treg cell levels can be used clinically as a predictive marker for differentiating Infliximab responders from nonresponders
