Clinical Trial: A Study to Evaluate Efficacy and Safety of Infliximab in Participant With Moderate-to-Severe Refractory Intestinal Behcet's Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official 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 Disea

Brief Summary: The purpose of this study is to evaluate the efficacy of infliximab in induction regimen by assessing the mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD) score of 20 or more in participants with active intestinal Behcet's disease who are refractory to conventional therapies.

Detailed Summary: This is an open-label (all participants know the identity of the intervention), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) study of Infliximab in participant with Moderate-to-Severe Refractory Intestinal Behcet's Disease. The study consists of 3 Phases: Screening Phase (4 weeks), induction Phase for 8 weeks, and maintenance Phase for 24 weeks extending from Week 0 (baseline), and a safety Follow up visit (Week 36 or approximately 6 weeks after the last administration of study drug). The duration of participation in the study for each participant is approximately 40 weeks. The mean decrease in Disease Activity Index for intestinal Behcet's disease (DAIBD) score of 20 or more will be evaluated primarily. Participants' safety will be monitored throughout the study.
Sponsor: Janssen Korea, Ltd., Korea

Current Primary Outcome: 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 ]

The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.


Original Primary Outcome: The Mean Decrease in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score of 20 or More [ Time Frame: Baseline to Week 8 ]

The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.


Current Secondary Outcome:

  • 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 ]
    The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.
  • Percentage of Participant With Crohn's Disease Activity Index (CDAI) 70 Response at Week 8 and 32 [ Time Frame: At Week 8 and 32 ]
    The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables. These 8 variables are: extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid stools, abdominal pain/cramping, and general well-being. The last 3 variables are scored over 7 days by the participant on a diary card. The CDAI 70-response is defined as a reduction from baseline in the CDAI score of greater than or equal to (>=) 70 points.
  • Change in Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 8 and 32 [ Time Frame: Baseline, Week 8 and 32 ]
    The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables. These 8 variables are: extraintestinal manifestations, abdominal mass, weight, hematocrit, use of antidiarrheal drug(s) and/or opiates, total number of liquid stools, abdominal pain/cramping, and general well-being. The last 3 variables are scored over 7 days by the participant on a diary card.
  • Change in C -Reactive Protein (CRP) Concentration From Baseline at Week 8 and 32 [ Time Frame: Baseline, Week 8 and 32 ]
    The CRP has been demonstrated to be useful as a marker of inflammation in patients with inflammatory bowel disease (IBD). In Behcet's Disease (BD), CRP concentrations in active disease participants have been found to be higher than those in inactive participants. Blood samples for the measurement of CRP will be collected from all participants. CRP will be assayed using a validated, high sensitivity CRP assay.
  • Change in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score From Baseline at Week 32 [ Time Frame: Baseline and Week 32 ]
    The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.
  • 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 ]
    The DAIBD will be assessed by collecting information on 8 different intestinal BD-related variables. These 8 variables are: fever, abdominal mass, abdominal tenderness, intestinal complications, extraintestinal manifestations, general well-being, abdominal pain, and total number of liquid stools. The last 3 variables are scored over 7 days by the participant on a diary card. Abdominal pain will be measured using the 11-point numeric rating scale (NRS) to standardize the evaluation of pain and the result of 11-point NRS will be divided into 4 grades (none, mild, moderate, severe) to fill out the DAIBD. where, None indicate 0; Mild indicate 1-3; Moderate indicate 4-6; Severe indicate 7-10.
  • Period Needed to Reach Clinical Remission From Baseline at Week 32 [ Time Frame: Up to Week 32 ]
    The duration for participants required to reach clinical remission will be analysed.
  • Percentage of Participants With Mucosal Healing at Week 32 [ Time Frame: Week 32 ]
    Mucosal healing will be assessed using endoscopy (ileocolonoscopy) in consenting participants. A video ileocolonoscopic examination will be performed according to the study reference manual provided to each site, at Screening and Week 32. Investigators will measure the longest diameter (none, >= 1 centimeter [cm] to less than [<] 2 cm, >= 2 cm to < 3, >= 3 cm) of ileum and/or colon largest open ulcer and assess mucosal healing in 4 grades compared to the baseline according to the following; Grade 0: Mucosal hea

    Original Secondary Outcome: Same as current

    Information By: Janssen Korea, Ltd., Korea

    Dates:
    Date Received: June 29, 2015
    Date Started: July 22, 2015
    Date Completion: December 31, 2017
    Last Updated: May 12, 2017
    Last Verified: May 2017