Phase 4 N=428 Predicting Response to Standardized Pediatric Colitis Therapy
Ulcerative Colitis
Primary: Number of Participants With Corticosteroid Free Remission (SFR) — 80; 70 Participants
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Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=60 A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
Ulcerative Colitis
Primary: The Number of Participants With Clinical Response at Week 8 — 44 Participants
Phase 2 N=15 Fecal Microbiota Transplant (FMT) in Pediatric Active Ulcerative Colitis and Pediatric Active Crohn's Colitis
Inflammatory Bowel Diseases · Ulcerative Colitis · Crohn Disease
Primary: 1. Safety and Tolerability of Universal Donor FMT Compared to Placebo: FMT-related Adverse Events Grade 2 or Above — 4; 0 Participants
Phase 3 N=59 Long-term Safety and Efficacy Study of Adalimumab in Pediatric Subjects With Ulcerative Colitis
Ulcerative Colitis
Primary: Number of Participants With Adverse Events (AEs) — 55; 15 Participants
Phase 3 N=53 Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
Ulcerative Colitis
Primary: Number of Participants With Clinical Response During Double-Blind Acute Phase at Week 8 — 10; 17 Participants — p=0.039
Phase 3 N=101 Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Primary: Co-Primary Endpoint 1: Percentage of Participants Who Achieved Clinical Remission as Measured by Partial Mayo Score (PMS) at Week 8 - Induction Period — 43.3; 59.6…
Phase 3 N=121 A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Colitis, Ulcerative
Primary: Percentage of Participants With Clinical Remission at Week 54 Based on Modified Mayo Score — 51.1; 43.5 percentage of participants
Phase 3 N=21 Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
Pediatric Ulcerative Colitis
Primary: Percent of Patients Who Achieved CAI Remission — 60.0; 80.0; 80.0; 77.8 percentage of participants
Phase 2 N=89 Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Ulcerative Colitis · Crohn's Disease
Primary: AUCWeek 14: Area Under the Serum Concentration-time Curve at Week 14 — 1933.5076; 3231.1001; 2344.4204; 3091.7957 h*ng/mL
Phase 1 N=52 Safety and Pharmacokinetics of MMX Mesalamine in Children and Adolescents With Ulcerative Colitis
Ulcerative Colitis
Primary: Area Under the Plasma Concentration Versus Time Curve (AUC) of MMX Mesalamine (5-ASA) at Steady State — 21411; 46173; 49213 ug*h/L
Phase 2 N=26 A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
Ulcerative Colitis
Primary: Pharmacokinetics (PK): Clearance of Mirikizumab — 0.000190 Liters per hour per kilogram (L/hr/kg)
Phase 3 N=83 Assessing the Safety/Efficacy of Asacol® Given Every 12 Hours to Children and Adolescents With Active Ulcerative Colitis
Ulcerative Colitis
Primary: Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population — 56.1; 55.0 % participants with treatment success…
Phase 1 N=23 Fecal Microbiota Transplantation in Pediatric Patients
Inflammatory Bowel Diseases (IBD) · Crohn's Disease (CD) · Ulcerative Colitis (UC)
Primary: Number of Occurrences of Adverse Events at 6 Months According to Adverse Event Term — 11; 5; 5; 3 Events
Phase 2 N=59 Long-term Safety With Vedolizumab Intravenous (IV) in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
Ulcerative Colitis · Crohn's Disease
Primary: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) — 100; 83.3; 100; 100 percentage of participants
Phase 1 N=13 Bacteriotherapy in Pediatric Inflammatory Bowel Disease
Inflammatory Bowel Disease · Crohn's Disease · Ulcerative Colitis
Primary: Number of Participants Who Responded to Stool Translplantation By 2 Weeks as Determined by Pediatric Ulcerative Colitis Activity Index (PUCAI)/Pediatric Crohn's Disease…
N/A N=15 The Use of Small Bowel Ultrasound to Predict Response to Remicade Induction
Crohn's Disease
Primary: Change in Bowel Wall Thickness (BWT) — 5; 4 mm
N/A N=2,239 European Safety Registry in Ulcerative Colitis (P04808)
Ulcerative Colitis
Primary: Percentage of Participants Within Each of Nine Pre-specified Adverse Event (AE) Categories — 9.1; 3.4; 10.5; 13.0 Percentage of participants
Phase 1 N=20 Gut Microbial Transplantation in Pediatric Inflammatory Bowel Diseases
Inflammatory Bowel Disease (IBD)
Primary: Clinical Response — 9 Participants — p=0.03
Phase 3 N=829 Efficacy and Safety of SPD476 in Maintaining Remission in Patients With Ulcerative Colitis
Ulcerative Colitis
Primary: Endoscopic Remission of Ulcerative Colitis (UC) at 6 Months — 83.7; 81.5 percent of participants
Phase 2 N=170 Efficacy and Safety Study of Apremilast to Treat Active Ulcerative Colitis
Ulcerative Colitis
Primary: Percentage of Participants Who Achieved a Clinical Remission by Total Mayo Score (TMS) at Week 12 — 12.1; 31.6; 21.8 Percentage of Participants — p=0.0142
Phase 3 N=32 Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
Ulcerative Colitis
Primary: Percentage of Patients Who Achieved Clinical Response — 57; 35 percentage of patients — p=0.05
Phase 2 N=105 A Trial of Rosiglitazone for Ulcerative Colitis
Ulcerative Colitis · Inflammatory Bowel Disease
Primary: Number of Participants With Improvement of Signs and Symptoms of UC at 12 Weeks — 23; 12 participants — p=.005
Phase 3 N=265 Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Proctitis · Proctosigmoiditis
Primary: Percentage of Participants Who Achieved Remission — 38.3; 25.8 percentage of participants — p=0.0324
Phase 3 N=281 Efficacy and Safety of Budesonide Foam for Participants With Active Mild to Moderate Ulcerative Proctitis or Proctosigmoiditis
Proctitis · Proctosigmoiditis
Primary: Percentage of Participants Who Achieved Remission — 44.0; 22.4 percentage of participants — p=<0.0001
Phase 3 N=591 A Study of Abatacept in Patients With Active Ulcerative Colitis
Ulcerative Colitis
Primary: Induction Period (IP); Number of Participants With Clinical Response (Per Mayo Score) at Week 12: IP Cohort 1 (IP1C) — 30; 26; 14; 41 participants — p=0.124
Phase 2 N=30 Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
Primary: Percentage of Participants Achieving Endoscopic Improvement — 16.7 percentage of participants
N/A N=45 Capsule Endoscopy in Inflammatory Bowel Disease (IBD) in Children
IBD
Primary: Diagnostic Yield of Magnetic Resonance Enterography (MRE) — 52 % Percentage of Diagnostic yeild
N/A N=15 Autoimmune Protocol Diet and Inflammatory Bowel Disease
Crohn Disease · Ulcerative Colitis · Inflammatory Bowel Diseases
Primary: Number of Participants With Clinical Remission for Crohn's Disease — 6 Participants
Phase 3 N=108 Safety Study of Entocort for Children With Crohn's Disease
Crohn's Disease
Primary: Adverse Event — 79 Patients
Phase 2 N=330 Long-Term Safety Of PF-00547659 In Ulcerative Colitis
Ulcerative Colitis
Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), and Who Withdrew From Treatment Due to…