Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
Vetëm përdoruesit e regjistruar mund të përkthejnë artikuj
Identifikohuni Regjistrohu
Lidhja ruhet në kujtesën e fragmenteve
Statusi
Sponsorët
Oregon Health and Science University
Bashkëpunëtorë
Centocor, Inc.
TRAJTIM KLINIKAL: NCT01266785
BioSeek: NCT01266785
Fjalë kyçe
Abstrakt
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.
Përshkrim
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.
Datat
| Verifikuar së fundmi: | 04/30/2019 |
| Paraqitur së pari: | 12/22/2010 |
| Regjistrimi i vlerësuar u dorëzua: | 12/22/2010 |
| Postuar së pari: | 12/23/2010 |
| Përditësimi i fundit i paraqitur: | 05/05/2019 |
| Përditësimi i fundit i postuar: | 05/07/2019 |
| Data e fillimit të studimit aktual: | 11/30/2010 |
| Data e vlerësuar e përfundimit primar: | 06/30/2012 |
| Data e vlerësimit të përfundimit të studimit: | 06/30/2012 |
Gjendja ose sëmundja
Crohn's Disease
Ndërhyrja / trajtimi
Drug: Infliximab
Faza
-
Kriteret e pranimit
| Moshat e pranueshme për studim | 18 Years Për të 18 Years |
| Gjinitë e pranueshme për studim | All |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | 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. |
Rezultati
Masat Kryesore të Rezultateve
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
