Trial · NCT03395184
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving Greater Than or Equal to (>=) 50 Percent (%) Reduction in Simple Endoscopic Score for Crohn's Disease (SES CD50) at Week 12: Induction Period | Week 12 | SES CD50 was defined as 50% improvement from baseline in SES-CD. Baseline was defined as last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease. |
| Primary | Number of Participants With Laboratory Test Abnormalities During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Pre-specified criteria for lab abnormalities included- hematology: hemoglobin(Hb), erythrocytes (ery),hematocrit:\<0.8\*lower limit of normal(LLN);reticulocytes: \<0.5\*LLN, \>1.5\*upper limit of normal(ULN); ery mean corpuscular(EMC) volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN,\>1.5\*ULN;lymphocyte,neutrophil(10\^9/L):\<0.8\*LLN,\>1.2\*ULN;basophil,eosinophil,monocyte(10\^9/L):\>1.2\*ULN;activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8;urine,glucose,protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported. |
| Primary | Number of Participants According to Categorization of Vital Signs During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (millimeter of mercury \[mmHg\]), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and change \>= 30 (mmHg) decrease; PR: value \> 120 (beats per minute \[bpm\]). |
| Primary | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc \>=480 milli second (msec) or an absolute change in QTc greater than (\>) 60 msec. Clinically significant ECG findings were determined by the investigator. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | An adverse event (AE) was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Primary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | A serious adverse event (SAE) was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Primary | Number of Participants With Discontinuations Due to Adverse Events During OLE Period | From start of study intervention in OLE period up to 4 weeks after last dose of study intervention (up to 56 weeks) | An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported. |
| Secondary | Number of Participants With Laboratory Test Abnormalities During Induction Period | From start of study intervention on Day 1 up to Week 12 | Pre-specified criteria for lab abnormalities included- hematology: hemoglobin, erythrocytes, hematocrit:\<0.8\*LLN; reticulocytes: \<0.5\*LLN, \>1.5\*ULN; EMC volume: \<0.9\*ULN, \>1.11\*ULN;EMC Hb: \<0.9\*LLN; platelets:\>1.75\*ULN; leukocytes(10\^9/L): \<0.6\*LLN, \>1.5\*ULN; lymphocyte, neutrophil(10\^9/L):\<0.8\*LLN, \>1.2\*ULN; basophil, eosinophil, monocyte(10\^9/L):\>1.2\*ULN; activated partial thromboplastin time (sec): \>1.1\*ULN. Chemistry: bilirubin(mg/dL),aspartate aminotransferase(AT),alanine AT(units per litre)\>3.0\*ULN; protein, albumin(g/dL):\<0.8\*LLN; creatinine, triglycerides (mg/dL):\>1.3\*ULN; urate(mg/dL):\>1.2\*ULN, potassium (mEq/L):\<0.9\*LLN; calcium (mg/dL): \<0.9\*LLN,\>1.1\*ULN. Urinalysis: pH\>8; urine, glucose, protein(mg/dl); ketones, nitrite, urine Hb(scalar):\>=1. Number of participants with any lab abnormality meeting pre-specified criteria are reported. |
| Secondary | Number of Participants According to Categorization of Vital Signs During Induction Period | From start of study intervention on Day 1 up to Week 12 | Vital signs including blood pressure (diastolic blood pressure \[DBP\], systolic blood pressure \[SBP\], and pulse rate \[PR\]) were measured in a supine position using automated devices. DBP included value \< 50 (mmHg), change \>=20 (mmHg) increase and change \>=20 (mmHg) decrease; SBP: value \< 90 (mmHg), change \>= 30 (mmHg) increase and PR: value \> 120 (bpm). |
| Secondary | Number of Participants With Abnormal Clinically Significant Electrocardiogram Findings During Induction Period | From start of study intervention on Day 1 up to Week 12 | Single twelve lead ECGs were obtained using an automated ECG machine after participant had rested quietly for at least 10 minutes in a supine position. QTc prolongations were defined as a QTc greater than or equal to (\>=)480 milli second (msec) or an absolute change in QTc greater than (\>)60 msec. Clinically significant ECG findings were determined by the investigator. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) During Induction Period | From start of study intervention on Day 1 up to Week 12 | An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. An AE was considered TEAE to a given treatment if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (TESAE) During Induction Period | From start of study intervention on Day 1 up to Week 12 | A SAE was any untoward medical occurrence at any dose that: resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions) or resulted in congenital anomaly/birth defect or was considered an important medical event. An SAE was considered as TESAE if the event started during the effective duration of treatment regardless of whether a similar event of equal or greater severity existed in the baseline period. |
| Secondary | Number of Participants Discontinuation Due to Adverse Events During Induction Period | From start of study intervention on Day 1 up to Week 12 | An AE was any untoward medical occurrence in a study participant administered a study intervention; the event need not necessarily have a causal relationship with the treatment or usage. Discontinuations from study due to TEAEs were defined as participants with an AE record indicating the AE caused permanent discontinuation from the study but action taken with study treatment was not drug withdrawn. Permanent discontinuations from any study intervention due to TEAEs were defined as participants with an AE record indicating that action taken with study treatment was drug withdrawn. In this outcome measure number of participants with discontinuation from study due to AEs and permanent discontinuation from study intervention due to AEs are reported. |
| Secondary | Number of Participants With Serious Infections During Induction Period | From start of study intervention on Day 1 up to Week 12 | Participants were monitored for development of any infection (viral, bacterial and fungal). Serious infections were treated infections that required parenteral antimicrobial therapy and were present with positive pre-treatment culture and required hospitalization for treatment/met other criteria that required the infection to be classified as SAE. An SAE was any untoward medical occurrence at any dose that: resulted in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity/results in congenital anomaly/birth defect. Treated infections were infections that required antimicrobial therapy by any route of administration/required any surgical intervention (e.g., incision and drainage). |
| Secondary | Percentage of Participants Who Achieved Clinically Meaningful Endoscopic Improvement (CMEI) (Reduction of >=3 Points From Baseline in SES-CD Score) at Week 12: Induction Period | Week 12 | CMEI was defined as reduction of \>=3 points from baseline in SES-CD score as assessed by centrally read SES-CD score. Baseline: last measurement prior to first dosing on Day1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for 4 domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5cm),2=Large ulcer(0.5-2cm),3=very large ulcer(\>2cm); ulcerated surface score: 0=none,1=\<10%,2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease. |
| Secondary | Mean Change From Baseline in SES-CD Score at Week 12: Induction Period | Baseline and Week 12 | Mean change from baseline in SES-CD score at Week 12 analyzed using analysis of covariance(ANCOVA)model with treatment,baseline disease activity/extent as factors, baseline SES CD score as covariate. Baseline=last measurement prior to first dosing on Day 1. Following bowel segments used for calculating SES-CD scores: Ileum,right C,transverse C,left C,rectum. Each segment assessed for four domains:presence of ulcers, ulcerated surface, affected surface,presence of narrowing, each score on a scale of 0-3,higher scores=more severe condition. Presence of ulcers score:0=none,1=small ulcer:(0.1-0.5cm),2=large ulcer(0.5-2cm),3=very large ulcer(\>2 cm);ulcerated surface score:0=none,1=\<10%,2=10-30%,3=\>30%;affected surface score:0=unaffected segment,1=\<50%, 2=50-75%,3=\>75%;presence of narrowing score:0=none,1=single,can be passed,2=multiple can be passed,3=cannot be passed. Total SES CD score=sum of each domain score for all 5 bowel segments,range from 0 to 60,higher score =more severe disease. |
| Secondary | Percentage of Participants Achieving >=25% Reduction in SES-CD From Baseline (SES-CD 25) at Week 12: Induction Period | Week 12 | SES CD25 was defined as \>=25% improvement from baseline in SES CD. Baseline was defined as the last measurement prior to first dosing on Day 1. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease. |
| Secondary | Percentage of Participants Achieving Endoscopic Remission (SES-CD Score of <= 2) at Week 12: Induction Period | Week 12 | Endoscopic remission was defined as SES-CD score of \<= 2. Following bowel segments were used for calculating SES-CD scores: Ileum, right colon(C), transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on a scale of 0 to 3, higher scores indicated more severe condition. Presence of ulcers score: 0=none, 1=small ulcer: (0.1-0.5 centimeter\[cm\]), 2=Large ulcer(0.5-2 cm), 3=very large ulcer(\>2 cm); ulcerated surface score: 0=none, 1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0 to 60, higher score indicating more severe disease. |
| Secondary | Percentage of Participants Achieving Mucosal Healing at Week 12: Induction Period | Week 12 | Mucosal healing was defined as complete absence of ulcers. |
| Secondary | Percentage of Participants Achieving CMEI at Week 64 Among Participants Who Achieved CMEI Response at Week 12 (Baseline of OLE Period): OLE Period | Week 64 (Week 52 of OLE period) | CMEI was defined as reduction of \>=3 points from baseline as assessed by centrally read SES CD score. Baseline: last measurement prior to first dosing on Day 1 of Week 12. Following bowel segments were used for calculating SES-CD scores: Ileum, right C, transverse C, left C and rectum. Each segment assessed for four domains: presence of ulcers, ulcerated surface, affected surface and presence of narrowing, each scored on scale of 0-3, higher scores indicated more severe condition. Presence of ulcers score: 0=none,1=small ulcer: (0.1-0.5 cm),2=Large ulcer(0.5-2 cm),3=very large ulcer(\>2 cm); ulcerated surface score: 0=none,1=\<10%, 2=10-30% and 3=\>30%; affected surface score: 0=unaffected segment, 1=\<50%, 2=50-75% and 3=\>75%; presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed and 3=cannot be passed. Total SES CD score was determined by sum of each domain score for all 5 bowel segments and ranged from 0-60, higher score indicating more severe disease. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
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