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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02505568
Date of registration: 29/06/2015
Prospective Registration: Yes
Primary sponsor: Janssen Korea, Ltd., Korea
Public title: A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease BEGIN
Scientific title: An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subject With Moderate-to-Severe Refractory Intestinal Behcet's Disease
Date of first enrolment: July 22, 2015
Target sample size: 33
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02505568
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 3
Countries of recruitment
Korea, Republic of
Contacts
Name:     Janssen Korea, Ltd Clinical Trial
Address: 
Telephone:
Email:
Affiliation:  Janssen Korea, Ltd
Key inclusion & exclusion criteria

Inclusion Criteria:

- Participant had diagnosed of definite or probable intestinal Behcet's Disease (BD)
prior to Screening

- Participant must have active intestinal BD, defined as; a) A baseline Disease Activity
Index for intestinal Behcet's disease (DAIBD) score of greater than or equal to (>=)
40; b) Endoscopy with evidence of active intestinal BD (defined as ulcerations in the
ileum and/or colon). The endoscopy must have occurred within 3 months prior to
baseline

- Must either be currently receiving treatment with, or have a history of having failed
to respond to, or tolerate, at least 1 of the following therapies as assessed by
treating physician: oral corticosteroids, 6-mercaptopurine (6-MP), azathioprine (AZA),
or methotrexate (MTX). a) Have no response to oral corticosteroids within the
preceding 18 months; b) Have no response to 6-MP, AZA or MTX within the preceding 5
years

- Prior to the baseline, the following conditions must be met: a) If receiving 6-MP,
AZA, or MTX must have been receiving it for at least 12 weeks, and the dose must be
stable for at least 4 weeks; b) If 6-MP, AZA, or MTX have been recently discontinued,
they must have been stopped for at least 4 weeks; c) If receiving oral
5-aminosalicylate (5-ASA) compounds or oral corticosteroids, the dose must have been
stable for at least 2 weeks; d) If oral 5-ASA compounds or oral corticosteroids have
been recently discontinued, they must have been stopped for at least 2 weeks; e) If
receiving cyclosporine, the dose must have been stable for at least 6 weeks; f) If
cyclosporine have been recently discontinued, they must have been stopped for at least
6 weeks

- Participant must be medically stable on the basis of physical examination, medical
history, vital signs and 12-lead electrocardiogram (ECG) performed at Screening. If
there are abnormalities, they must be consistent with the underlying illness in the
study population, or the participant may be included only if the investigator judge
the abnormalities from normal to be not clinically significant or to be appropriate.
This determination must be recorded in the participant's source documents by the
investigator

Exclusion Criteria:

- Participant has complications of intestinal BD such as symptomatic strictures or
stenoses, short gut syndrome, central nervous system or vascular manifestation, or any
other manifestation that might be anticipated to require surgery, could preclude the
use of the DAIBD to assess response to therapy, or would possibly confound the ability
to assess the effect of treatment with infliximab

- Participant currently has or is suspected to have an abscess. Recent cutaneous and
perianal abscesses are not exclusionary if drained and adequately treated at least 3
weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses,
provided that there is no anticipated need for any further surgery. Participants with
active fistulas may be included if there is no anticipation of a need for surgery and
there are currently no abscesses identified

- Participant has had any kind of bowel resection within 6 months or any other
intra-abdominal surgery within 3 months prior to baseline

- Participant has a draining (ie, functioning) stoma or ostomy

- Participant has received any of the following prescribed medications or therapies
within the specified period: a) Intravenous (IV) corticosteroids within 3 weeks prior
to baseline; b) Other oral immunomodulatory agents (eg, 6-thioguanine (6-TG),
tacrolimus, sirolimus, or mycophenolate mofetil) within 6 weeks prior to baseline; c)
Non-biologic experimental or investigational agents within 4 weeks or within 5
half-lives of agent prior to baseline, whichever is longer; d) Other immunomodulatory
biologic agents within 12 weeks or within 5 half-lives of agent prior to baseline,
whichever is longer; e) Treatment with apheresis (eg, Adacolumn apheresis) or total
parenteral nutrition (TPN) as a treatment for intestinal BD within 3 weeks prior to
baseline



Age minimum: 19 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Behcet Disease
Intervention(s)
Drug: Infliximab
Primary Outcome(s)
The Mean Decrease in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score of 20 or More From Baseline at Week 8 [Time Frame: Baseline and Week 8]
Secondary Outcome(s)
Change in C -Reactive Protein (CRP) Concentration From Baseline at Week 8 and 32 [Time Frame: Baseline, Week 8 and 32]
Change in Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 8 and 32 [Time Frame: Baseline, Week 8 and 32]
Change in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score From Baseline at Week 32 [Time Frame: Baseline and Week 32]
Number of Participants with Adverse Events (AEs) and Serious AEs [Time Frame: Up to Week 36]
Percentage of Participant With Clinical Remission (Disease Activity Index for Intestinal Behcet's Disease [DAIBD] Score less than or equal to [<=] 19) at Week 32 [Time Frame: Week 32]
Percentage of Participant With Clinical Response by Disease Activity Index for Intestinal Behcet's Disease (DAIBD) at Week 8 and 32 [Time Frame: At Week 8 and 32]
Percentage of Participant With Crohn's Disease Activity Index (CDAI) 70 Response at Week 8 and 32 [Time Frame: At Week 8 and 32]
Percentage of Participants With Mucosal Healing at Week 32 [Time Frame: Week 32]
Period Needed to Reach Clinical Remission From Baseline at Week 32 [Time Frame: Up to Week 32]
Secondary ID(s)
CR107121
REMICADEBEC3001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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