Crohn Disease
Conditions
Brief summary
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Detailed description
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.
Interventions
DRUGUstekinumab approximately 6 mg/kg (IV)
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
DRUGPlacebo (SC)
Participants will receive SC injection of placebo at Week 0.
DRUGPlacebo (IV)
Participants will receive IV infusion of placebo at Week 0.
DRUGUstekinumab 90 mg (SC) Group 1
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
DRUGUstekinumab 90 mg (SC) Group 2
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Sponsors
Janssen-Cilag Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (\>=) 220 and \<=450 with at least one of the following: Elevated C-reactive protein (CRP) (\>3.0 milligram per liter \[mg/L\]); and/or elevated Fecal calprotectin (fCal) \>250 milligram per kilogram \[mg/kg\]); and/or endoscopy (performed less than or equal to (\<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon) * Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral corticosteroids (for example {e.g.}, prednisone, budesonide) at a prednisone-equivalent dose of \<=40 mg/day or \<=9 mg/day of budesonide, antibiotics used as the primary treatment of Crohn's disease, or conventional immunomodulators (i.e., azathioprine \[AZA\], 6-mercaptopurine \[6-MP\], or methotrexate \[MTX\]) are permitted providing the doses indicated are stable before baseline or have been discontinued before baseline within the protocol defined durations
Exclusion criteria
* Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab * Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified * Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline * A draining (i.e., functioning) stoma or ostomy * Received ustekinumab intravenous re-induction after the initial weight-tiered-based IV induction dose of ustekinumab * Any known history of shortened frequency of SC dose administration (\<q8w) for a secondary loss of response where the participant did not, in the opinion of the treating physician, benefit from the dose interval shortening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Clinical Response at Week 16 | Week 16 | Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for hematology (hematocrit) was reported. |
| Percentage of Participants With Clinical Remission at Week 16 | Week 16 | Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. |
| Percentage of Participants With Clinical Response at Week 8 | Week 8 | Clinical response was defined as a \>=100-point reduction from the baseline in CDAI score or a CDAI score \<150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. |
| Percentage of Participants With Clinical Remission at Week 8 | Week 8 | Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. |
| Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 | Week 16 | Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (\<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as \<=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. |
| Percentage of Participants With Clinical Remission at Week 24 | Week 24 | Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score. |
| Percentage of Participants With Clinical Response at Week 24 | Week 24 | Clinical response was defined as a \>=100-point reduction from the baseline in CDAI score or a CDAI score \<150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score. |
| Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 | Week 24 | Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (\<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as \<=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward. |
| Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported. |
| Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From baseline (Week 0) up to Week 36 | A serious adverse event (SAE) was an adverse event 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; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. |
| Percentage of Participants With Treatment-emergent Infections | From baseline (Week 0) up to Week 36 | Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. |
| Percentage of Participants With Treatment-emergent Serious Infections | From baseline (Week 0) up to Week 36 | Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. |
| Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported. |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported. |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported. |
| Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Baseline, Weeks 8, 16, 24 | Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported. |
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | From baseline (Week 0) up to Week 36 | An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported. |
Countries
Austria, Czechia, France, Germany, Italy, Netherlands, Russia, South Korea, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Ustekinumab (IV Re-induction) Participants who initially responded to ustekinumab induction therapy followed by a secondary loss of response (LoR) to ustekinumab administered as subcutaneous (SC) injection every 8 weeks (q8w) maintenance therapy received a weight-tiered based re-induction dose of ustekinumab 6 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion and placebo matching to ustekinumab as SC injection at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. | 108 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) Participants who initially responded to ustekinumab induction therapy followed by a secondary LoR to ustekinumab administered as SC injection q8w maintenance therapy received ustekinumab 90 mg as SC injection and placebo matching to ustekinumab as an IV infusion at Week 0. At Weeks 8 and 16, all participants received ustekinumab 90 mg maintenance dose as SC injection. At Week 24, all participants underwent study assessments before resuming their standard-of-care therapy at the discretion of the treating physician. Participants were followed-up for safety up to Week 36. | 107 |
| Total | 215 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Other | 16 | 17 |
| Overall Study | Withdrawal by Subject | 7 | 11 |
Baseline characteristics
| Characteristic | Group 1: Ustekinumab (IV Re-induction) | Total | Group 2: Ustekinumab (Continuous q8w SC Maintenance) |
|---|---|---|---|
| Age, Continuous | 41.8 years STANDARD_DEVIATION 13.63 | 40.9 years STANDARD_DEVIATION 13.36 | 40 years STANDARD_DEVIATION 13.07 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 103 Participants | 206 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 17 Participants | 10 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants | 9 Participants | 3 Participants |
| Race (NIH/OMB) White | 90 Participants | 179 Participants | 89 Participants |
| Region of Enrollment Czech Republic | 1 Participants | 5 Participants | 4 Participants |
| Region of Enrollment France | 9 Participants | 14 Participants | 5 Participants |
| Region of Enrollment Germany | 36 Participants | 69 Participants | 33 Participants |
| Region of Enrollment Italy | 6 Participants | 10 Participants | 4 Participants |
| Region of Enrollment Netherlands | 1 Participants | 5 Participants | 4 Participants |
| Region of Enrollment Republic of Korea | 4 Participants | 11 Participants | 7 Participants |
| Region of Enrollment Russia | 3 Participants | 8 Participants | 5 Participants |
| Region of Enrollment Spain | 10 Participants | 16 Participants | 6 Participants |
| Region of Enrollment Sweden | 1 Participants | 2 Participants | 1 Participants |
| Region of Enrollment United Kingdom | 4 Participants | 8 Participants | 4 Participants |
| Region of Enrollment United States of America | 33 Participants | 67 Participants | 34 Participants |
| Sex: Female, Male Female | 62 Participants | 124 Participants | 62 Participants |
| Sex: Female, Male Male | 46 Participants | 91 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 108 | 0 / 107 |
| other Total, other adverse events | 73 / 108 | 77 / 107 |
| serious Total, serious adverse events | 9 / 108 | 13 / 107 |
Outcome results
Primary
Percentage of Participants With Clinical Response at Week 16
Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Time frame: Week 16
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Response at Week 16 | 49.1 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Response at Week 16 | 37.4 Percentage of participants |
Comparison: The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).p-value: 0.08995% CI: [-1.5, 24.5]Cochran-Mantel Haenszel-chi-square test
Secondary
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: Alkaline Phosphatase | -0.072 Units per Liter (U/L) | Standard Deviation 12.9488 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: ALT | 0.463 Units per Liter (U/L) | Standard Deviation 10.147 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: ALT | -0.347 Units per Liter (U/L) | Standard Deviation 9.3642 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: AST | -0.525 Units per Liter (U/L) | Standard Deviation 12.0147 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: Alkaline Phosphatase | -0.296 Units per Liter (U/L) | Standard Deviation 14.2649 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: AST | -0.208 Units per Liter (U/L) | Standard Deviation 12.6366 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: ALT | -0.811 Units per Liter (U/L) | Standard Deviation 8.3898 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: AST | 0.741 Units per Liter (U/L) | Standard Deviation 5.6718 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: Alkaline Phosphatase | -1.343 Units per Liter (U/L) | Standard Deviation 10.7404 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: AST | 1.519 Units per Liter (U/L) | Standard Deviation 7.3047 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: Alkaline Phosphatase | -0.582 Units per Liter (U/L) | Standard Deviation 10.3565 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: Alkaline Phosphatase | 0.923 Units per Liter (U/L) | Standard Deviation 11.5154 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: Alkaline Phosphatase | 0.078 Units per Liter (U/L) | Standard Deviation 16.1594 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: ALT | -0.412 Units per Liter (U/L) | Standard Deviation 7.9001 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: ALT | -0.101 Units per Liter (U/L) | Standard Deviation 9.975 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 24: ALT | 2.224 Units per Liter (U/L) | Standard Deviation 15.5979 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 8: AST | 0.144 Units per Liter (U/L) | Standard Deviation 4.8584 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) | Week 16: AST | 0.163 Units per Liter (U/L) | Standard Deviation 5.4557 |
Secondary
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 8 | 0.108 millimoles per liter (mmol/L) | Standard Deviation 2.5714 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 16 | -0.165 millimoles per liter (mmol/L) | Standard Deviation 2.2299 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 24 | 0.235 millimoles per liter (mmol/L) | Standard Deviation 2.2928 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 8 | 0.126 millimoles per liter (mmol/L) | Standard Deviation 0.3596 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 16 | 0.105 millimoles per liter (mmol/L) | Standard Deviation 0.3745 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 24 | 0.067 millimoles per liter (mmol/L) | Standard Deviation 0.3732 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 8 | 0.078 millimoles per liter (mmol/L) | Standard Deviation 2.9136 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 16 | -0.299 millimoles per liter (mmol/L) | Standard Deviation 2.4798 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 24 | 0.160 millimoles per liter (mmol/L) | Standard Deviation 2.4107 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 8 | 0.279 millimoles per liter (mmol/L) | Standard Deviation 1.005 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 16 | 0.204 millimoles per liter (mmol/L) | Standard Deviation 1.2812 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 24 | 0.304 millimoles per liter (mmol/L) | Standard Deviation 1.2031 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 8 | 0.022 millimoles per liter (mmol/L) | Standard Deviation 0.0967 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 16 | 0.007 millimoles per liter (mmol/L) | Standard Deviation 0.101 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 24 | 0.008 millimoles per liter (mmol/L) | Standard Deviation 0.1101 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 8 | 0.005 millimoles per liter (mmol/L) | Standard Deviation 0.2015 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 16 | 0.006 millimoles per liter (mmol/L) | Standard Deviation 0.1946 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 24 | 0.018 millimoles per liter (mmol/L) | Standard Deviation 0.1612 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 16 | 0.007 millimoles per liter (mmol/L) | Standard Deviation 0.1098 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 8 | -0.061 millimoles per liter (mmol/L) | Standard Deviation 2.2375 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 8 | 0.248 millimoles per liter (mmol/L) | Standard Deviation 1.071 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 16 | 0.011 millimoles per liter (mmol/L) | Standard Deviation 2.337 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 24 | 0.021 millimoles per liter (mmol/L) | Standard Deviation 0.1938 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Sodium: Week 24 | -0.117 millimoles per liter (mmol/L) | Standard Deviation 2.0454 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 16 | 0.029 millimoles per liter (mmol/L) | Standard Deviation 1.2841 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 8 | 0.050 millimoles per liter (mmol/L) | Standard Deviation 0.3269 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 24 | 0.004 millimoles per liter (mmol/L) | Standard Deviation 0.1109 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 16 | -0.002 millimoles per liter (mmol/L) | Standard Deviation 0.3933 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | BUN/urea: Week 24 | 0.179 millimoles per liter (mmol/L) | Standard Deviation 1.0629 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Potassium: Week 24 | 0.001 millimoles per liter (mmol/L) | Standard Deviation 0.3185 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 16 | 0.026 millimoles per liter (mmol/L) | Standard Deviation 0.1905 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 8 | -0.520 millimoles per liter (mmol/L) | Standard Deviation 2.4714 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Calcium: Week 8 | 0.013 millimoles per liter (mmol/L) | Standard Deviation 0.0968 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 16 | -0.489 millimoles per liter (mmol/L) | Standard Deviation 2.5398 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Phosphate: Week 8 | 0.046 millimoles per liter (mmol/L) | Standard Deviation 0.2024 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) | Chloride: Week 24 | -0.481 millimoles per liter (mmol/L) | Standard Deviation 2.216 |
Secondary
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Total Bilirubin | 1.476 micromole per liter (mcmol/L) | Standard Deviation 3.4135 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Direct Bilirubin | 0.109 micromole per liter (mcmol/L) | Standard Deviation 0.5393 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Direct Bilirubin | 0.086 micromole per liter (mcmol/L) | Standard Deviation 0.5495 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Creatinine | -0.446 micromole per liter (mcmol/L) | Standard Deviation 8.9118 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Total Bilirubin | 0.687 micromole per liter (mcmol/L) | Standard Deviation 3.0396 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Creatinine | 0.624 micromole per liter (mcmol/L) | Standard Deviation 9.7987 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Direct Bilirubin | 0.154 micromole per liter (mcmol/L) | Standard Deviation 0.691 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Creatinine | 1.717 micromole per liter (mcmol/L) | Standard Deviation 9.5267 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Total Bilirubin | 0.639 micromole per liter (mcmol/L) | Standard Deviation 2.5303 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Creatinine | 0.336 micromole per liter (mcmol/L) | Standard Deviation 8.402 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Total Bilirubin | -0.131 micromole per liter (mcmol/L) | Standard Deviation 2.9617 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Total Bilirubin | 0.555 micromole per liter (mcmol/L) | Standard Deviation 3.6679 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Total Bilirubin | 0.254 micromole per liter (mcmol/L) | Standard Deviation 3.1664 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Direct Bilirubin | -0.010 micromole per liter (mcmol/L) | Standard Deviation 0.5998 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Direct Bilirubin | 0.071 micromole per liter (mcmol/L) | Standard Deviation 0.7628 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 24: Direct Bilirubin | 0.009 micromole per liter (mcmol/L) | Standard Deviation 0.7612 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 8: Creatinine | -0.308 micromole per liter (mcmol/L) | Standard Deviation 9.6489 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) | Week 16: Creatinine | 1.117 micromole per liter (mcmol/L) | Standard Deviation 9.0316 |
Secondary
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 8 | 0.009 Percentage of red blood cells | Standard Deviation 0.0313 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 16 | 0.010 Percentage of red blood cells | Standard Deviation 0.0306 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 24 | 0.009 Percentage of red blood cells | Standard Deviation 0.0358 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 8 | -0.001 Percentage of red blood cells | Standard Deviation 0.277 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 16 | 0.001 Percentage of red blood cells | Standard Deviation 0.0356 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) | Week 24 | 0.001 Percentage of red blood cells | Standard Deviation 0.0349 |
Secondary
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specified parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Hematology (Hemoglobin) | 3.245 Grams per liter (g/L) | Standard Deviation 10.4621 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Chemistry (Albumin) | 0.741 Grams per liter (g/L) | Standard Deviation 2.9613 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Chemistry (Albumin) | 0.765 Grams per liter (g/L) | Standard Deviation 2.9456 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Chemistry (Total protein) | 0.588 Grams per liter (g/L) | Standard Deviation 4.6806 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Hematology (Hemoglobin) | 3.203 Grams per liter (g/L) | Standard Deviation 11.2408 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Chemistry (Total protein) | 0.340 Grams per liter (g/L) | Standard Deviation 5.2418 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Chemistry (Albumin) | 0.567 Grams per liter (g/L) | Standard Deviation 3.0649 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Chemistry (Total protein) | 0.605 Grams per liter (g/L) | Standard Deviation 4.415 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Hematology (Hemoglobin) | 2.893 Grams per liter (g/L) | Standard Deviation 9.5568 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Chemistry (Total protein) | 0.333 Grams per liter (g/L) | Standard Deviation 5.4954 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Hematology (Hemoglobin) | -0.185 Grams per liter (g/L) | Standard Deviation 7.8669 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Hematology (Hemoglobin) | 0.835 Grams per liter (g/L) | Standard Deviation 10.4652 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Hematology (Hemoglobin) | -0.400 Grams per liter (g/L) | Standard Deviation 11.261 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Chemistry (Albumin) | 0.286 Grams per liter (g/L) | Standard Deviation 2.6671 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Chemistry (Albumin) | 0.554 Grams per liter (g/L) | Standard Deviation 3.3753 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 24: Chemistry (Albumin) | 0.221 Grams per liter (g/L) | Standard Deviation 3.169 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 8: Chemistry (Total protein) | 0.265 Grams per liter (g/L) | Standard Deviation 4.3803 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) | Week 16: Chemistry (Total protein) | 0.783 Grams per liter (g/L) | Standard Deviation 4.769 |
Secondary
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
Time frame: Baseline, Weeks 8, 16, 24
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received. Here, 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure and 'n' (number analyzed) signifies participants who were evaluated at specified timepoints for specific parameters.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Neutrophils | -0.195 10^9 cells/L | Standard Deviation 2.0172 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Absolute Lymphocytes | -0.088 10^9 cells/L | Standard Deviation 0.6599 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Total WBC | -0.329 10^9 cells/L | Standard Deviation 2.27 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Eosinophils | -0.009 10^9 cells/L | Standard Deviation 0.0876 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Neutrophils | -0.038 10^9 cells/L | Standard Deviation 2.2944 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Eosinophils | -0.014 10^9 cells/L | Standard Deviation 0.1176 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8:Neutrophils | -0.235 10^9 cells/L | Standard Deviation 1.761 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Eosinophils | -0.001 10^9 cells/L | Standard Deviation 0.0912 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Absolute Lymphocytes | -0.101 10^9 cells/L | Standard Deviation 0.4962 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Platelets | -13.65 10^9 cells/L | Standard Deviation 56.553 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Total WBC | -0.149 10^9 cells/L | Standard Deviation 2.2347 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Platelets | -13.28 10^9 cells/L | Standard Deviation 60.105 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Absolute Lymphocytes | -0.088 10^9 cells/L | Standard Deviation 0.569 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Platelets | -10.89 10^9 cells/L | Standard Deviation 62.671 |
| Group 1: Ustekinumab (IV Re-induction) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Total WBC | -0.386 10^9 cells/L | Standard Deviation 1.8358 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Platelets | -0.53 10^9 cells/L | Standard Deviation 56.624 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Total WBC | -0.272 10^9 cells/L | Standard Deviation 1.7301 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Total WBC | -0.124 10^9 cells/L | Standard Deviation 2.1404 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Total WBC | 0.104 10^9 cells/L | Standard Deviation 1.6612 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8:Neutrophils | -0.241 10^9 cells/L | Standard Deviation 1.6154 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Neutrophils | -0.053 10^9 cells/L | Standard Deviation 2.1811 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Neutrophils | 0.133 10^9 cells/L | Standard Deviation 1.4312 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Absolute Lymphocytes | -0.020 10^9 cells/L | Standard Deviation 0.3415 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Absolute Lymphocytes | -0.052 10^9 cells/L | Standard Deviation 0.3997 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Absolute Lymphocytes | -0.021 10^9 cells/L | Standard Deviation 0.396 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Eosinophils | -0.004 10^9 cells/L | Standard Deviation 0.1153 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Eosinophils | -0.013 10^9 cells/L | Standard Deviation 0.133 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 24: Eosinophils | -0.008 10^9 cells/L | Standard Deviation 0.1136 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 8: Platelets | -0.67 10^9 cells/L | Standard Deviation 51.591 |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) | Week 16: Platelets | 4.53 10^9 cells/L | Standard Deviation 60.785 |
Secondary
Percentage of Participants With Clinical Remission at Week 16
Percentage of participants with clinical remission at Week 16 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Time frame: Week 16
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Remission at Week 16 | 33.3 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Remission at Week 16 | 27.1 Percentage of participants |
Comparison: The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).p-value: 0.33895% CI: [-6, 17.8]CMH chi-square test (2-sided)
Secondary
Percentage of Participants With Clinical Remission at Week 24
Percentage of participants with clinical remission at Week 24 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Time frame: Week 24
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Remission at Week 24 | 37.0 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Remission at Week 24 | 27.1 Percentage of participants |
Secondary
Percentage of Participants With Clinical Remission at Week 8
Percentage of participants with clinical remission at Week 8 were reported. Clinical remission was defined as CDAI score of \<150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Time frame: Week 8
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Remission at Week 8 | 35.2 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Remission at Week 8 | 29.0 Percentage of participants |
Comparison: The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).p-value: 0.31495% CI: [-5.8, 18.6]CMH chi-square test (2-sided)
Secondary
Percentage of Participants With Clinical Response at Week 24
Clinical response was defined as a \>=100-point reduction from the baseline in CDAI score or a CDAI score \<150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Time frame: Week 24
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Response at Week 24 | 47.2 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Response at Week 24 | 39.3 Percentage of participants |
Secondary
Percentage of Participants With Clinical Response at Week 8
Clinical response was defined as a \>=100-point reduction from the baseline in CDAI score or a CDAI score \<150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Time frame: Week 8
Population: Full analysis set included all randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Clinical Response at Week 8 | 51.9 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Clinical Response at Week 8 | 44.9 Percentage of participants |
Comparison: The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).p-value: 0.395% CI: [-6, 20.2]CMH chi-square test (2-sided)
Secondary
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16
Percentage of participants with normalization at Week 16, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (\<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as \<=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Time frame: Week 16
Population: Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 | 33.3 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 | 14.9 Percentage of participants |
Comparison: The fixed sequence testing method was used. CMH chi-square test (2-sided) stratified by baseline CDAI score (\<= 300 or \> 300), and prior biologic failure status at baseline (yes or no).p-value: 0.00495% CI: [6.8, 30.2]CMH chi-square test (2-sided)
Secondary
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24
Percentage of participants with normalization at Week 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (\<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as \<=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Time frame: Week 24
Population: Full analysis set included all randomized participants with either elevated CRP and/or elevated fCal at baseline.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 | 26.9 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 | 21.3 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.
Time frame: From baseline (Week 0) up to Week 36
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 70.4 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) | 72.9 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Infections
Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time frame: From baseline (Week 0) up to Week 36
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Treatment-emergent Infections | 33.3 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Treatment-emergent Infections | 29.9 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) was an adverse event 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; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time frame: From baseline (Week 0) up to Week 36
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 8.3 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) | 12.1 Percentage of participants |
Secondary
Percentage of Participants With Treatment-emergent Serious Infections
Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time frame: From baseline (Week 0) up to Week 36
Population: Safety analysis set included all randomized participants who received at least 1 administration of study agent. Participants were analyzed according to the actual treatment received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: Ustekinumab (IV Re-induction) | Percentage of Participants With Treatment-emergent Serious Infections | 1.9 Percentage of participants |
| Group 2: Ustekinumab (Continuous q8w SC Maintenance) | Percentage of Participants With Treatment-emergent Serious Infections | 1.9 Percentage of participants |