A Multicenter Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease (CD) Patients Undergoing Surgical Resection Who Are at an Increased Risk of Recurrence



Status:Terminated
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 99
Updated:4/21/2016
Start Date:November 2010
End Date:December 2014

Use our guide to learn which trials are right for you!

Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Comparing REMICADE (Infliximab) and Placebo in the Prevention of Recurrence in Crohn's Disease Patients Undergoing Surgical Resection Who Are at Increased Risk of Recurrence

REMICADE (infliximab) is a drug used to treat active Crohn's disease and is being tested in
an experiment to see if it may be useful in preventing relapse of Crohn's disease after
surgical resection. This study will compare the effects (both good and bad) of REMICADE
(infliximab) to those of placebo. Placebo looks like the drug being studied but has no
active ingredients.

The purpose of this study is to assess the effects of REMICADE (infliximab) in preventing
relapse of Crohn's disease after surgical resection. Patients will be assigned to a group
that will initially receive either infliximab or placebo. Each patient who is allowed to
join the study is put into a group by chance (randomly), like flipping a coin. There is a
possibility that patients can receive both the study drug and placebo at different times in
the study. If a patient is initially randomized to receive placebo, and their study doctor
confirms that they have had a return of active Crohn's Disease symptoms, they can receive
infliximab. If a patient is initially randomized to receive infliximab, and their study
doctor confirms that they are experiencing symptoms of Crohn's Disease, they may receive an
increase in their infliximab dose. Infusions will be administered at Week 0 and then every 8
weeks thereafter through Week 200. The study will use a measure of Crohn's Disease activity
that will be evaluated at each visit and at any time the patient has symptoms suggestive of
their disease getting worse in order to capture recurrence. During the study, patients who
meet the study definition of clinical recurrence will be eligible to have a blinded
infliximab dose increase of 5 mg/kg. In other words, patients receiving placebo would
receive infliximab 5 mg/kg, and patients receiving infliximab 5 mg/kg would have a dose
increase to 10 mg/kg. Approximately 175 sites will be utilized, and approximately 290
patients will be enrolled. The interval between the first and last dose of study agent is
200 weeks. The planned duration of study participation is a maximum of 209 weeks (with a
1-week screening period, a 200-week treatment period, and a final study visit at Week 208).
Group I (infliximab infusions): infliximab (5 mg/kg) will be administered by intravenous
(IV) infusion at Week 0 and every 8 weeks thereafter through Week 200. Group II (placebo
infusions): placebo will be administered by IV infusion at Week 0 and every 8 weeks
thereafter through Week 200

Inclusion Criteria:

- Have a documented diagnosis of CD confirmed by endoscopic, histologic and/or
radiologic studies prior to resection or by tissue obtained at resection

- Have undergone an ileocolonic surgical resection

- Patients must also be at an increased risk of recurrence of active CD

- Patients must not have previously discontinued infliximab as a result of tolerability
issues or they must be naive to treatment with infliximab. Provided patients meet the
above criteria pertaining to infliximab, they are eligible to enroll if they received
prior treatment with adalimumab and/or certolizumab

- Patients must undergo screening for HBV

- Baseline CDAI < 200

- Have adequate blood and liver test values

Exclusion Criteria:

- Have a history of latent or active granulomatous infection, including histoplasmosis
or coccidioidomycosis, prior to screening

- Have a chest radiograph within 3 months prior to the first infusion of study agent
that shows a clinically significant abnormality, such as a malignancy or infection,
or any abnormalities suggestive of TB

- Have macroscopically active CD which was not resected at the time of surgery

- Do not meet the criteria for being at an increased risk of postoperative recurrence
of active CD as outlined in the inclusion criteria

- Have evidence of an active infection at the time of randomization or have had a
serious infection not related to CD (e.g., hepatitis, pneumonia, or pyelonephritis),
within 6 months prior to screening

- Have or have had an opportunistic infection (e.g., herpes zoster [shingles],
cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria
other than TB) within 6 months prior to screening

- Have any known malignancy or history of malignancy within the 5-year period prior to
screening (with the exception of squamous or basal cell carcinoma of the skin that
has been completely excised without evidence of recurrence)

- Have any condition that, in the opinion of the investigator, would compromise the
well-being of the patient or the study or prevent the patient from meeting or
performing study requirements.
We found this trial at
63
sites
1932
mi
from 91732
Ann Arbor, MI
Click here to add this to my saved trials
8190
mi
from 91732
Adelaide,
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
1589
mi
from 91732
Baton Rouge, LA
Click here to add this to my saved trials
1784
mi
from 91732
Birmingham, AL
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2467
mi
from 91732
Burlington, VT
Click here to add this to my saved trials
2194
mi
from 91732
Chapel Hill, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
2208
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
2278
mi
from 91732
Chevy Chase, MD
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1880
mi
from 91732
Cincinnati, OH
Click here to add this to my saved trials
2032
mi
from 91732
Cleveland, OH
Click here to add this to my saved trials
1417
mi
from 91732
Clive, IA
Click here to add this to my saved trials
1924
mi
from 91732
Decatur, GA
Click here to add this to my saved trials
2202
mi
from 91732
Durham, NC
Click here to add this to my saved trials
2103
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
2504
mi
from 91732
Glastonbury, CT
Click here to add this to my saved trials
1206
mi
from 91732
Grapevine, TX
Click here to add this to my saved trials
2447
mi
from 91732
Great Neck, NY
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
1528
mi
from 91732
Iowa City, IA
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
99
mi
from 91732
La Jolla, CA
Click here to add this to my saved trials
2515
mi
from 91732
Lebanon, NH
Click here to add this to my saved trials
1350
mi
from 91732
Lees Summit, MO
Click here to add this to my saved trials
1881
mi
from 91732
Lexington, KY
Click here to add this to my saved trials
813
mi
from 91732
Littleton, CO
Click here to add this to my saved trials
1813
mi
from 91732
Louisville, KY
Click here to add this to my saved trials
1978
mi
from 91732
Macon, GA
Click here to add this to my saved trials
1654
mi
from 91732
Madison, WI
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2499
mi
from 91732
Middletown, CT
Click here to add this to my saved trials
2407
mi
from 91732
Morristown, NJ
Click here to add this to my saved trials
2220
mi
from 91732
Naples, FL
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
1655
mi
from 91732
New Orleans, LA
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
1227
mi
from 91732
Plano, TX
Click here to add this to my saved trials
1501
mi
from 91732
Plymouth, MN
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2214
mi
from 91732
Raleigh, NC
Click here to add this to my saved trials
333
mi
from 91732
Redwood City, CA
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
1524
mi
from 91732
Rochester, MN
Click here to add this to my saved trials
2245
mi
from 91732
Rochester, NY
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
939
mi
from 91732
Tacoma, WA
Click here to add this to my saved trials
2300
mi
from 91732
Towson, MD
Click here to add this to my saved trials
1964
mi
from 91732
Troy, MI
Click here to add this to my saved trials
2303
mi
from 91732
Weston, FL
Click here to add this to my saved trials
2184
mi
from 91732
Winter Park, FL
Click here to add this to my saved trials