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

NCT02505568 | Completed Phase 3

• 2 other identifiers: CR107121REMICADEBEC3001
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 5

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.

Conditions

Behcet Disease

Keywords

Behcet Disease; Infliximab; Adult participants

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Percentage of Participant With Clinical Response by Disease Activity Index for Intestinal Behcet's Disease (DAIBD) at Week 8 and 32

  At Week 8 and 32

• Percentage of Participant With Crohn's Disease Activity Index (CDAI) 70 Response at Week 8 and 32

  At Week 8 and 32

• Change in Crohn's Disease Activity Index (CDAI) Score From Baseline at Week 8 and 32

  Baseline, Week 8 and 32

• Change in C -Reactive Protein (CRP) Concentration From Baseline at Week 8 and 32

  Baseline, Week 8 and 32

• Change in Disease Activity Index for Intestinal Behcet's Disease (DAIBD) Score From Baseline at Week 32

  Baseline and Week 32

Study Arms (1)

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.

Drug: Infliximab

Interventions

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.

Infliximab

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (5)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gangwon-do, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36578194 DERIVED

Related Links

• 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

MeSH Terms

Conditions

Behcet Syndrome

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Janssen Korea, Ltd Clinical Trial

  Janssen Korea, Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2015
• First Posted: July 22, 2015
• Study Start: July 22, 2015
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: October 17, 2019

Record last verified: 2019-10

Locations

KR (5)