Inflammatory Bowel Diseases
Conditions
Keywords
Pediatric Inflammatory Bowel Disease, Infliximab, Pediatric Participants, Pediatric Ulcerative Colitis, Pediatric Crohn's Disease, Dose Escalation
Brief summary
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.
Detailed description
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.
Interventions
DRUGInfliximab
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.
Sponsors
Janssen Scientific Affairs, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
* Must have a biopsy-confirmed diagnosis of Crohn's disease (CD) or ulcerative colitis (UC) prior to study entry * Must meet concomitant medication stability criteria as specified in protocol * Is considered eligible according to the tuberculosis (TB) Screening criteria specified in protocol * Must have negative stool results for enteric pathogens. Stool studies must include a stool culture and Clostridium difficile toxin assay. These must have been performed during Screening or the current episode of disease exacerbation as long as the stool studies were performed within 4 months prior to the first administration of infliximab at Week 0 * Must have screening laboratory test results as specfied in the protocol * Must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed participants prior to Screening * Must not have discontinued infliximab therapy
Exclusion criteria
* Must not require, or must not have required, within the 2 months prior to Screening, surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intraabdominal or pancreatic abscess requiring surgical drainage, or other conditions possibly confounding the evaluation of benefit from infliximab treatment * Must not have presence or history of colonic or small bowel obstruction within 6 months prior to Screening, confirmed by objective radiographic or endoscopic evidence of a stricture with resulting obstruction (example, dilation of the colon or small bowel proximal to the stricture on barium radiograph or an inability to traverse the stricture at endoscopy) * Must not have local manifestations of CD, such as fistulae, strictures, abscesses, or other disease complications for which surgery might be indicated. Enterocutaneuous fistulae for which surgery is not indicated, are allowed * Must not have presence of a stoma * Must not have documented short bowel syndrome (more than 100 centimeter in total of small bowel resected)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants | Week 16 | 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. |
| Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants | Week 16 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | 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 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. |
| Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Baseline, Week 16 and Week 56 | 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. |
| Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | 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 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. |
| Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | 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 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. |
| Sustained Clinical Response Through 56 Weeks After Dose Escalation | Up to Week 56 | 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. |
| Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants | Baseline, Week 16 And Week 56 | 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. |
| Correlation of Wong-Baker FACES Scale With Clinical Remission and Response at Week 16 | 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. |
| Relationship Between Abdominal Pain PCDAI Sub-Score And the Wong-Baker Faces Scale For CD Participants | Week 16 and 56 | 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. |
| Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants | 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 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. |
| 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 | Baseline, Week 16 and Week 56 | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
Reference arm was planned only for safety analysis in participants being treated with labeled dosing of infliximab.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 45 |
| 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. | 8 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 4 | 2 |
| Overall Study | Other | 6 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 1 |
Baseline characteristics
| Characteristic | Reference Group | Dose Escalation Group | Total |
|---|---|---|---|
| Age, Continuous | 14.1 years STANDARD_DEVIATION 1.9 | 12.9 years STANDARD_DEVIATION 2.7 | 13.9 years STANDARD_DEVIATION 2.05 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 37 Participants | 7 Participants | 44 Participants |
| Region of Enrollment Canada | 3 Participants | 1 Participants | 4 Participants |
| Region of Enrollment United States | 42 Participants | 7 Participants | 49 Participants |
| Sex: Female, Male Female | 16 Participants | 4 Participants | 20 Participants |
| Sex: Female, Male Male | 29 Participants | 4 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 45 | 0 / 9 |
| other Total, other adverse events | 36 / 45 | 8 / 9 |
| serious Total, serious adverse events | 2 / 45 | 1 / 9 |
Outcome results
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.
Time frame: Week 16
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation Group | Clinical Response at Week 16 After Dose Escalation as Evaluated by Mayo Score in Ulcerative Colitis (UC) Participants | 0 Participants |
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.
Time frame: Week 16
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation Group | Clinical Response at Week 16 After Dose Escalation as Evaluated by Pediatric Crohn's Disease Activity Index (PCDAI) in Crohn's Disease (CD) Participants | 4 Participants |
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.
Time frame: Baseline, Week 16 and Week 56
Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.
| Arm | Measure | Group | Value |
|---|---|---|---|
| Unknown | 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 | Change at Week 16 | — |
| Unknown | 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 | Change at Week 56 | — |
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.
Time frame: Baseline, Week 16 and Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 1: Change at Week 16 | 0 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 1: Change at Week 56 | 0 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 2: Change at Week 16 | 0 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 2: Change at Week 56 | NA Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 3: Change at Week 16 | 0 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 3: Change at Week 56 | NA Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 4: Change at Week 16 | 1 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 4: Change at Week 56 | -4 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 5: Change at Week 16 | -5 Score on a scale |
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in CD Participants | Participant 5: Change at Week 56 | -5 Score on a scale |
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.
Time frame: Baseline, Week 16 And Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Abdominal Pain Using the Wong-Baker FACES Scale at Week 16 and Week 56 in UC Participants | Change at Week 16 | -4 Score on scale |
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.
Time frame: Baseline, Week 16 And Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency at Week 16 and Week 56 in UC Participants | Change at Week 16 | -6 Score on a scale |
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.
Time frame: Baseline, Week 16 and Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 1: Change at Week 16 | -9 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 1: Change at Week 56 | -3 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 2: Change at Week 16 | 2 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 2: Change at Week 56 | NA Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 3: Change at Week 16 | -1 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 3:Change at Week 56 | NA Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 4: Change at Week 16 | -2 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 4: Change at Week 56 | -1 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 5: Change at Week 16 | 1 Score on a scale |
| Dose Escalation Group | Change From Baseline in Absolute Stool Frequency Based on PCDAI Score at Week 16 and Week 56 in CD Participants | Participant 5: Change at Week 56 | 1 Score on a scale |
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.
Time frame: Baseline, Week 16 and Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Rectal Bleeding Sub-Scores of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change at Week 16 | 0 Score on a scale |
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.
Time frame: Baseline, Week 16 and Week 56
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dose Escalation Group | Change From Baseline in Stool Frequency Sub-Score of the Partial Mayo Score at Week 16 and Week 56 in UC Participants | Change at Week 16 | -2 Score on a scale |
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.
Time frame: Week 16
Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.
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.
Time frame: Week 16 and 56
Population: As the study was terminated early with lesser participants and lesser sample size, data for this OM was not collected.
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.
Time frame: Up to Week 56
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dose Escalation Group | Sustained Clinical Response Through 56 Weeks After Dose Escalation | 2 Participants |