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
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ClinicalTrials.gov Identifier: NCT01190839 |
Recruitment Status
:
Terminated
(Study is terminated as per Sponsor's Decision.)
First Posted
: August 30, 2010
Results First Posted
: October 22, 2014
Last Update Posted
: February 4, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Biological: Infliximab Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 297 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | December 2014 |
Actual Study Completion Date : | December 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: Infliximab
Infliximab Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
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Biological: Infliximab
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
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Placebo Comparator: Placebo
Placebo Type=equal unit=mg number=5 form=intravenous infusion route=intravenous use once every 8 weeks
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Drug: Placebo
Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
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- Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76 [ Time Frame: Baseline up to Week 76 ]CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD] before or at Week 76 were considered to have clinical recurrence.
- Percentage of Participants With Endoscopic Recurrence of CD Prior to or at Week 76 [ Time Frame: Baseline up to Week 76 ]Endoscopic recurrence is defined as an ileal Rutgeert's score of >= i2 either at the anastomotic site or elsewhere in the gastrointestinal tract. In addition, participants who had a treatment failure (initiated a prohibited CD medication, had a prohibited use of a CD medication, or had a surgery for CD) prior to Week 76, and who developed a new draining external fistula or re-opening and draining of a previously existing external fistula or developed a new internal fistula, new perianal abscess or new intra-abdominal abscess more than 3 months after the date of the index surgery were considered to have had endoscopic recurrence prior to or at Week 76.
- Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 104 [ Time Frame: Baseline up to Week 104 ]CR criteria:1) A >=70-point increase from baseline in CDAI score [in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities];2)A CDAI score >=200;3)Evidence of endoscopic recurrence [ileal Rutgeerts score of >=i2 at anastomotic site or its equivalent elsewhere in GI tract] and 4)A negative stool test for C. difficile toxin (if, in the opinion of the investigator, the participant's symptoms are predominantly diarrheal); or at least 1 of followings:1) developing a new draining external fistula;2)re-opening and draining of a previously existing external fistula;3)developing a new internal fistula;4)developing a new perianal abscess or 5)developing a new intra-abdominal abscess more than 3 months after date of index surgery. In addition, participants who had a treatment failure [initiated a prohibited CD medication, had prohibited use of CD medication, or had surgery for CD]before or at Week 104 were considered to have clinical recurrence.

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Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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): NCT01190839

Study Director: | Janssen Biotech Inc. Clinical Trial | Janssen Biotech, Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Janssen Biotech, Inc. |
ClinicalTrials.gov Identifier: | NCT01190839 History of Changes |
Other Study ID Numbers: |
CR017080 REMICADECRD3001 ( Other Identifier: Janssen Biotech Inc. ) 2010-018431-18 ( EudraCT Number ) PREVENT ( Other Identifier: Janssen Biotech Inc. ) |
First Posted: | August 30, 2010 Key Record Dates |
Results First Posted: | October 22, 2014 |
Last Update Posted: | February 4, 2016 |
Last Verified: | December 2015 |
Keywords provided by Janssen Biotech, Inc.:
Crohn's Disease Inflammatory Bowel Disease infliximab TNF-alpha |
Additional relevant MeSH terms:
Crohn Disease Recurrence Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |
Disease Attributes Pathologic Processes Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |