Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
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|ClinicalTrials.gov Identifier: NCT00688636|
Recruitment Status : Completed
First Posted : June 3, 2008
Results First Posted : September 26, 2016
Last Update Posted : September 26, 2016
|Condition or disease||Intervention/treatment||Phase|
|Crohn's Disease||Drug: infliximab Drug: placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||January 2009|
|Active Comparator: 1||
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
Other Name: Remicade
|Placebo Comparator: 2||
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
- Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year [ Time Frame: one year ]Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.
- Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200 [ Time Frame: One year ]The Crohn's Disease Activity Index (CDAI) is calculated by a measurement of symptoms, signs, and lab tests over a time period of the previous 7 days. The CDAI includes: Number of very soft stools; sum of abdominal pain ratings: (0=none, 1= mild, 2=moderate, 3=severe); general well being (0=well, 1=slightly below par, 2=poor, 3=very poor, 4=terrible); Symptoms or findings presumed related to Crohn's disease (present): arthritis or arthralgia, iritis or uveitis, erythema nodosum, pyoderma gangrenosum, aphthous stomatitis, anal fissure, fistula or perirectal abscess, other bowel related fistula, febrile episode over 100 degrees during past week, taking lomotil or opiates for diarrhea, abnormal mass (0=none; 0.4=questionable; 1=present) hematocrit [(typical-current) X 6] Normal average male = 47, female =42, body weight
- Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis [ Time Frame: One year ]Histologic recurrence based on a histologic activity score and the presence of polymononuclear cells. The maximum score is 14 per biopsy site.
- C-reactive Protein Concentration as a Surrogate Marker of Inflammation [ Time Frame: one year ]The CRP was obtained at each study visit as a surrogate marker of inflammation. The CRP was recorded as milligram per deciliter (mg/dl). A normal CRP was 0-0.8 mg/dl; levels exceeding 0.8 mg/dl indicated inflammation.
- Mean Erythrocyte Sedimentation Rate [ Time Frame: one year ]erythrocyte sedimentation rate value - blood test
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): NCT00688636
|United States, Pennsylvania|
|University of Pittsburgh|
|Pittsburgh, Pennsylvania, United States, 15261|
|Principal Investigator:||Miguel D Regueiro, M.D.||University of Pittsburgh|