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| ID | Type | Description | Link |
|---|---|---|---|
| REMICADEBEC3001 | Other Identifier | Janssen Korea, Ltd |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infliximab | Experimental | Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 and will be evaluated for the induction phase at Week 8. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion at Week 14, Week 22, and Week 30 in the maintenance phase and will be evaluated at Week 32. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 for the induction phase. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion every 8 weeks up to week 32 in the maintenance phase. |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Decrease in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score of 20 or More From Baseline at 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. | Baseline and Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participant With Clinical Response by Disease Activity Index for Intestinal Behcet's Disease (DAIBD) 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Korea, Ltd Clinical Trial | Janssen Korea, Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Busan | South Korea | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36578194 | Derived | Cheon JH, Kim HS, Han DS, Kim SK, Shin SJ, Kim JS, Ye BD, Song GA, Lee Y, Kim Y, Lee Y, Kim WH; BEGIN Study Group. Efficacy and Safety of Infliximab in Intestinal Behcet's Disease: A Multicenter, Phase 3 Study (BEGIN). Gut Liver. 2023 Sep 15;17(5):777-785. doi: 10.5009/gnl220278. Epub 2022 Dec 29. |
| Label | URL |
|---|---|
| An Interventional, Open-label, Single Arm, Multicenter Study to Evaluate Efficacy and Safety of Infliximab in Subjects with Moderate-to-Severe Refractory Intestinal Behcet's Disease | View source |
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| At Week 8 and 32 |
| Percentage of Participant With Crohn's Disease Activity Index (CDAI) 70 Response 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. | At Week 8 and 32 |
| Change in Crohn's Disease Activity Index (CDAI) Score From Baseline 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. | Baseline, Week 8 and 32 |
| Change in C -Reactive Protein (CRP) Concentration From Baseline at 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. | Baseline, Week 8 and 32 |
| Change in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score From Baseline at 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. | Baseline and Week 32 |
| 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 | 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. | Week 32 |
| Period Needed to Reach Clinical Remission From Baseline at Week 32 | The duration for participants required to reach clinical remission will be analysed. | Up to Week 32 |
| Percentage of Participants With Mucosal Healing at 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 healing; Grade 1: marked improvement (reduction to <= 1/4); Grade 2: improvement (reduction to <= 1/2 - > 1/4); Grade 3: no change or worse (reduction less than 1/2 or expansion). | Week 32 |
| Number of Participants with Adverse Events (AEs) and Serious AEs | An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | Up to Week 36 |
| Daegu |
| South Korea |
| Gangwon-do | South Korea |
| Gyeonggi-do | South Korea |
| Seoul | South Korea |
| ID | Term |
|---|---|
| D001528 | Behcet Syndrome |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014606 | Uveitis, Anterior |
| D015864 | Panuveitis |
| D014605 | Uveitis |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D056660 | Hereditary Autoinflammatory Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017445 | Skin Diseases, Vascular |
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| ID | Term |
|---|---|
| D000069285 | Infliximab |
| ID | Term |
|---|---|
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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