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| ID | Type | Description | Link |
|---|---|---|---|
| C0168IBD4020 | Other Identifier | Janssen Scientific Affairs, LLC | |
| 2015-001653-32 | EudraCT Number |
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Study was terminated due to the inability to enroll a sufficient number of the required subject population
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The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain clinical response) from dose escalation above the currently approved dose [5 milligram (mg)/kilogram (kg) every 8 weeks (q8wk)] and the safety of that dose escalation.
This is a multicenter (when more than one hospital or medical school team work on a medical research study), prospective (study following participants forward in time), open-label (all people know the identity of the intervention) study of infliximab in pediatric participants with inflammatory bowel disease. The study consists of 3 Phases: screening Phase (up to 4 weeks), open-label treatment Phase (56 weeks) and follow up safety Phase (8 weeks). The duration of participation in the study for each participant is approximately up to 68 weeks (including screening period). Participants' efficacy and safety outcomes will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation Group | Experimental | Participants must have completed: a) recommended infliximab induction dosing regimen of 5 milligram (mg)/kilogram (kg) at Weeks 0, 2, and 6, followed by at least 1 maintenance doses of 5 mg/kg every 8 weeks (q8wk); or b) induction regimen with doses >6 mg/kg and have received at least 2 maintenance doses of 5 mg/kg q8wk with clinical response for at least 28 days after the most recent 5 mg/kg maintenance dose; or c) maintenance doses >6 mg/kg within past 6 months and at least 2 maintenance doses of 5 mg/kg q8wk with clinical response for at least 28 days after the most recent 5 mg/kg maintenance dose; d) must have lost clinical response, after first or subsequent q8wk maintenance dose of infliximab 5 mg/kg for participants who have completed the recommended infliximab induction dosing regimen or, after most recent (second or later) q8wk maintenance dose of infliximab 5 mg/kg for participants with an induction regimen with doses >6 mg/kg or with previous maintenance doses >6 mg/kg. |
|
| Reference Group | Experimental | Participants must have completed: a) the recommended infliximab induction dosing regimen of 5 mg/kg at Weeks 0, 2, and 6, and have maintained a stable clinical response to infliximab after at least 1 maintenance doses of 5 mg/kg q8wk; or b) an induction regimen with doses >6 mg/kg and have received at least 2 maintenance doses of 5 mg/kg q8wk and have maintained clinical response for at least 28 days after the most recent 5 mg/kg maintenance dose 5 mg/kg maintenance dose; or c) maintenance doses >6 mg/kg within the past 6 months and at least 2 maintenance doses of 5 mg/kg q8wk and have maintained a clinical response for at least 28 days after the most recent 5 mg/kg maintenance dose 5 mg/kg maintenance dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infliximab | Drug | Participants in the dose escalation group will escalate dose from infliximab 5 mg/kg q8w to 10 mg/kg q8w at the time of loss response. Participants in the reference group will be maintained on infliximab 5 mg/kg q8w. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants | Clinical response was defined as Crohn's disease (CD) participants with decrease from baseline in PCDAI of greater than or equal to (>=) 15 points with total score of less than or equal to (<=) 30 points. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for Dose escalation (DE) group only. | Week 16 |
| Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants | Clinical Response as per Mayo score was defined as decrease from baseline in partial Mayo score of >= 2 points and >= 30 percent (%) and decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of less than or equal to (<=) 1 point (for UC participants). A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Data for this OM was planned to be analyzed for the DE group only. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained Clinical Response Through 56 Weeks After Dose Escalation | Sustained clinical response at Week 56 was defined as achieving clinical response per the primary OM definitions at Week 16 and maintaining clinical response at 1 year after dose escalation (Week 56). Clinical response was defined as a decrease from baseline in PCDAI of >= 15 points with total score of =< 30 points (for CD participants) and a decrease from baseline in partial Mayo score of >=2 points and >=30% and a decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of =< point (for UC participants). Data for this OM was planned to be analyzed for the DE group only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Scientific Affairs, LLC Clinical Trial | Janssen Scientific Affairs, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab.
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| ID | Title | Description |
|---|---|---|
| FG000 | Reference Group | Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2018 | Apr 22, 2020 |
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| Up to Week 56 |
| Change From Baseline in Abdominal Pain and Loose/Watery Stool Frequency Sub-scores of the PCDAI at Week 16 and Week 56 in CD Participants | Abdominal and loose/watery stool frequency was evaluated by using the relevant sub-scores of the PCDAI. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 and Week 56 |
| Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Change from baseline in abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in CD participants was reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 and Week 56 |
| Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Change from baseline in Absolute stool frequency at Week 16 and Week 56 in CD participants were reported. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. An absolute stool frequency subscore of =<1 point was indicative of mild disease. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 and Week 56 |
| Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change from baseline in Stool frequency sub-score of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute stool frequency subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 and Week 56 |
| Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change from baseline in rectal bleeding sub-scores of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute rectal bleeding subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 and Week 56 |
| Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants | Change from baseline in Abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in UC participants were reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 And Week 56 |
| Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants | Change from baseline in absolute stool frequency at Week 16 and Week 56 in UC participants were reported. Data for this OM was planned to be analyzed for the DE group only. | Baseline, Week 16 And Week 56 |
| Correlation of Wong-Baker FACES Scale With Clinical Remission and Response at Week 16 | The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis. | Week 16 |
| Relationship Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Participants | PCDAI is validated clinical tool used to assess disease severity in pediatric CD participants. PCDAI collects information on disease-related variables:Total number of liquid stools, abdominal pain, and general well-being (scored by participants or participant's legal representative);Extra-intestinal manifestations;Physical examinations of abdominal mass, perirectal disease;Weight change, height change or, height velocity;Hematocrit;erythrocyte sedimentation rate; albumin. PCDAI score is calculated as sum of individual component scores and ranges from 0-100 points. Wong-Baker FACES Pain Scale combines pictures and numbers to allow pain to be rated by children over age of 3. Scale shows a series of faces ranging from a happy face at 0, "No hurt" to crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis. | Week 16 and 56 |
| Los Angeles |
| California |
| United States |
| San Francisco | California | United States |
| Hartford | Connecticut | United States |
| Wilmington | Delaware | United States |
| Atlanta | Georgia | United States |
| Chicago | Illinois | United States |
| Peoria | Illinois | United States |
| Indianapolis | Indiana | United States |
| Shreveport | Louisiana | United States |
| Portland | Maine | United States |
| Baltimore | Maryland | United States |
| Boston | Massachusetts | United States |
| Waltham | Massachusetts | United States |
| Rochester | Minnesota | United States |
| Saint Paul | Minnesota | United States |
| Kansas City | Missouri | United States |
| Mineola | New York | United States |
| New York | New York | United States |
| Stony Brook | New York | United States |
| Chapel Hill | North Carolina | United States |
| Cleveland | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Pittsburgh | Pennsylvania | United States |
| Charleston | South Carolina | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Fairfax | Virginia | United States |
| Madison | Wisconsin | United States |
| Vancouver | British Columbia | Canada |
| Halifax | Nova Scotia | Canada |
| Hamilton | Ontario | Canada |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Montreal | Quebec | Canada |
| Sherbrooke | Quebec | Canada |
| FG001 | Dose Escalation Group | Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64. |
| Cross-over to Dose Escalation Group | This participant was counted in both arms for safety analysis. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Reference Group | Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation. |
| BG001 | Dose Escalation Group | Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants | Clinical response was defined as Crohn's disease (CD) participants with decrease from baseline in PCDAI of greater than or equal to (>=) 15 points with total score of less than or equal to (<=) 30 points. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for Dose escalation (DE) group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint | Posted | Number | Participants | Week 16 |
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| Primary | Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants | Clinical Response as per Mayo score was defined as decrease from baseline in partial Mayo score of >= 2 points and >= 30 percent (%) and decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of less than or equal to (<=) 1 point (for UC participants). A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and physician's global assessment [PGA]) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint | Posted | Number | Participants | Week 16 |
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| Secondary | Sustained Clinical Response Through 56 Weeks After Dose Escalation | Sustained clinical response at Week 56 was defined as achieving clinical response per the primary OM definitions at Week 16 and maintaining clinical response at 1 year after dose escalation (Week 56). Clinical response was defined as a decrease from baseline in PCDAI of >= 15 points with total score of =< 30 points (for CD participants) and a decrease from baseline in partial Mayo score of >=2 points and >=30% and a decrease in rectal bleeding sub-score by >= 1 point or achievement of an absolute sub-score of =< point (for UC participants). Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint. | Posted | Number | Participants | Up to Week 56 |
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| Secondary | Change From Baseline in Abdominal Pain and Loose/Watery Stool Frequency Sub-scores of the PCDAI at Week 16 and Week 56 in CD Participants | Abdominal and loose/watery stool frequency was evaluated by using the relevant sub-scores of the PCDAI. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. Data for this OM was planned to be analyzed for the DE group only. | As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected. | Posted | Baseline, Week 16 and Week 56 |
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| Secondary | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Change from baseline in abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in CD participants was reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint. | Posted | Number | Score on a scale | Baseline, Week 16 and Week 56 |
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| Secondary | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Change from baseline in Absolute stool frequency at Week 16 and Week 56 in CD participants were reported. PCDAI includes three history items (abdominal pain, number of liquid stools, general wellbeing), five physical examination items (abdominal examination, perirectal disease, extraintestinal manifestations, weight, height), and three laboratory tests (hematocrit, albumin, erythrocyte sedimentation rate). Items are scored on a three-point scale (zero, 5, or 10 points) except for hematocrit and erythrocyte sedimentation rate which are scored as zero, 2.5 or 5 points. PCDAI scores can range from zero to 125 with higher scores indicating more active disease. An absolute stool frequency subscore of =<1 point was indicative of mild disease. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint. | Posted | Number | Score on a scale | Baseline, Week 16 and Week 56 |
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| Secondary | Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change from baseline in Stool frequency sub-score of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute stool frequency subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Score on a scale | Baseline, Week 16 and Week 56 |
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| Secondary | Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change from baseline in rectal bleeding sub-scores of the partial Mayo score at Week 16 and Week 56 in UC participants were reported. A Partial Mayo Score which is Mayo score without endoscopy ranges from 0 (normal or inactive disease) to 9 (severe disease) and calculated as the sum of 3 subscores (stool frequency, rectal bleeding and PGA) with each ranging from 0 to 3 (0=normal, 1=mild, 2=moderate, 3=severe). An absolute rectal bleeding subscore of <=1 point was indicative of mild disease. Higher scores indicate more severe disease. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Score on a scale | Baseline, Week 16 and Week 56 |
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| Secondary | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants | Change from baseline in Abdominal pain using the Wong-Baker FACES scale at Week 16 and Week 56 in UC participants were reported. The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". The participant must choose the face that best describes how they are feeling. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Score on scale | Baseline, Week 16 And Week 56 |
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| Secondary | Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants | Change from baseline in absolute stool frequency at Week 16 and Week 56 in UC participants were reported. Data for this OM was planned to be analyzed for the DE group only. | Analysis population included all participants who received at least one infusion of infliximab after enrollment. Here 'N' (number of participants analyzed) signifies the number of participants for whom data was available for this endpoint and 'n' (number analyzed) signifies number of participants analyzed at specified timepoints. | Posted | Number | Score on a scale | Baseline, Week 16 And Week 56 |
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| Secondary | Correlation of Wong-Baker FACES Scale With Clinical Remission and Response at Week 16 | The Wong-Baker FACES Pain Scale is a pain scale that combines pictures and numbers to allow pain to be rated by children over the age of 3. The scale shows a series of faces ranging from a happy face at 0, "No hurt" to a crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis. | As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected. | Posted | Week 16 |
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| Secondary | Relationship Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Participants | PCDAI is validated clinical tool used to assess disease severity in pediatric CD participants. PCDAI collects information on disease-related variables:Total number of liquid stools, abdominal pain, and general well-being (scored by participants or participant's legal representative);Extra-intestinal manifestations;Physical examinations of abdominal mass, perirectal disease;Weight change, height change or, height velocity;Hematocrit;erythrocyte sedimentation rate; albumin. PCDAI score is calculated as sum of individual component scores and ranges from 0-100 points. Wong-Baker FACES Pain Scale combines pictures and numbers to allow pain to be rated by children over age of 3. Scale shows a series of faces ranging from a happy face at 0, "No hurt" to crying face at 10 "Hurts worst". Data for this OM was planned to be analyzed for the DE group only. Statistical test of the hypothesis (regression model) was not performed due to insufficient data being collected to permit analysis. | As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected. | Posted | Week 16 and 56 |
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Up to Week 64
The safety analysis population included all participants who received at least one infusion of infliximab after enrollment. Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab. One participants who had crossed-over from reference group to Dose escalation group was counted in both arms and safety is presented accordingly.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Reference Group | Participants received infliximab 5 mg/kg intravenous (IV) infusion every 8 weeks (q8wk) up to 56 weeks with a final safety visit at Week 64. Those who lost clinical response during participation in the study were eligible to cross over to the Dose Escalation Group and receive a total of 56 weeks of therapy with infliximab, which included duration of therapy while in the Reference Group prior to dose escalation. | 0 | 45 | 2 | 45 | 36 | 45 |
| EG001 | Dose Escalation Group | Participants received infliximab 10 mg/kg IV infusion q8wk from Week 0 to 56 with a final safety visit at Week 64. | 0 | 9 | 1 | 9 | 8 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dry Eye | Eye disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anorectal Disorder | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Colitis Ulcerative | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Epigastric Discomfort | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Faeces Soft | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lip Swelling | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Mouth Haemorrhage | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tongue Erythema | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tooth Disorder | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tooth Impacted | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Discomfort | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Allergy to Arthropod Bite | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Food Allergy | Immune system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Adenovirus Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Clostridium Difficile Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ear Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eczema Infected | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Epstein-Barr Virus Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Eye Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Otitis Media | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pharyngitis Streptococcal | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Staphylococcal Impetigo | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Viral Upper Respiratory Tract Infection | Infections and infestations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Animal Bite | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Burns Second Degree | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Joint Dislocation | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Joint Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ligament Sprain | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Limb Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lip Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Soft Tissue Injury | Injury, poisoning and procedural complications | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| C-Reactive Protein Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Faecal Calprotectin Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Heart Rate Irregular | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hepatic Enzyme Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vitamin D Decreased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| White Blood Cell Count Increased | Investigations | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Vitamin D Deficiency | Metabolism and nutrition disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Costochondritis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Synovial Cyst | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Torticollis | Musculoskeletal and connective tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin Papilloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dizziness Postural | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hemianopia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Ovarian Cyst | Reproductive system and breast disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Asthma Exercise Induced | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dyspnoea Exertional | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Respiratory Tract Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Acne Cystic | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Skin Warm | Skin and subcutaneous tissue disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
| |
| Orthostatic Hypertension | Vascular disorders | MedDRA Version 21.1 | Non-systematic Assessment |
|
Study was terminated due to the inability to enroll a sufficient number of the required participants.
If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director | Janssen Scientific Affairs | 844-434-4210 | ClinicalTrialDisclosure@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2019 | Apr 22, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| C536315 | Pediatric ulcerative colitis |
| C536215 | Pediatric Crohn's disease |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
|
|
|
|
|
| Participants |
|
|
|
|
|
|
| Participants |
|