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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03345849
Registration number
NCT03345849
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017
Date last updated
23/11/2022
Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
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Scientific title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Subjects With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Conventional and/or Biologic Therapies
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Secondary ID [1]
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2017-001240-35
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Secondary ID [2]
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M14-433
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Universal Trial Number (UTN)
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Trial acronym
U-EXCEL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease
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Condition category
Condition code
Oral and Gastrointestinal
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Inflammatory bowel disease
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Crohn's disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Upadacitinib
Treatment: Drugs - Placebo for Upadacitinib
Placebo Comparator: Placebo - Participants will receive placebo once daily for 12 weeks in Part 1. Clinical non-responders will receive 45 mg upadacitinib once daily for 12 weeks in Part 2.
Experimental: Upadacitinib - Participants will receive 45 mg upadacitinib once daily for 12 weeks in Part 1. Clinical non-responders will receive 30 mg upadacitinib once daily for 12 weeks in Part 2.
Treatment: Drugs: Upadacitinib
Oral; Tablet
Treatment: Drugs: Placebo for Upadacitinib
Oral; Tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 12
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Assessment method [1]
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The co-primary endpoint for United States (US)/Food and Drug Administration (FDA) regulatory purposes was clinical remission based on CDAI at Week 12.
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as a CDAI score less than 150.
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Timepoint [1]
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Week 12
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Primary outcome [2]
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Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
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Assessment method [2]
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The co-primary endpoint for European Union (EU)/European Medicines Agency (EMA) regulatory purposes was clinical remission defined based on two patient reported outcomes, average daily stool frequency (SF) and average daily abdominal pain score (APS). Clinical remission per PROs was defined as average daily very soft or liquid SF = 2.8 and average daily APS = 1.0 and neither worse than Baseline.
Participants recorded APS and the number of very soft or liquid SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).
The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-report outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
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Timepoint [2]
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Week 12
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Primary outcome [3]
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Percentage of Participants With Endoscopic Response at Week 12
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Assessment method [3]
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Endoscopic response at Week 12 was a co-primary endpoint for both the US/FDA and EU/EMA regulatory purposes. Endoscopic response was defined as greater than 50% decrease in Simple Endoscopic Score for Crohn's Disease (SES-CD) from Baseline of the induction study (or for participants with an SES-CD of 4 at Baseline, at least a 2-point reduction from Baseline), as scored by independent external and blinded central readers.
The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [1]
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Percentage of Participants With Endoscopic Remission at Week 12
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Assessment method [1]
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Endoscopic remission is defined as an SES-CD = 4 and at least 2 point reduction from Baseline and no subscore > 1 in any individual variable,as scored by independent external and blinded central readers.
The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease.
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Timepoint [1]
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Baseline and Week 12
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Secondary outcome [2]
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Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per CDAI at Week 12
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Assessment method [2]
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Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per CDAI at Week 12, assessed for participants taking corticosteroids for CD at Baseline.
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) at Week 12
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Assessment method [3]
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The FACIT-Fatigue questionnaire is a self-administered patient questionnaire that consists of 13 questions designed to measure the degree of fatigue experienced by participants in the previous 7 days, including physical fatigue (e.g., I feel tired), functional fatigue (e.g., trouble finishing things), emotional fatigue (e.g., frustration), and social consequences of fatigue (e.g., limits social activity). Participants respond to the questions on a scale from 0 (not at all) to 4 (very much). The FACIT-Fatigue score is computed by summing the item scores, after reversing those items that are worded in the negative direction. The FACIT-Fatigue score ranges from 0 to 52, where higher scores represent less fatigue. A positive change from Baseline indicates improvement.
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Timepoint [3]
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Baseline and Week 12
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Secondary outcome [4]
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
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Assessment method [4]
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The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.
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Timepoint [4]
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Baseline and Week 12
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Secondary outcome [5]
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Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
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Assessment method [5]
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Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
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Timepoint [5]
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Baseline and Week 2
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Secondary outcome [6]
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Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
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Assessment method [6]
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Clinical response 100 (CR-100) is defined as a decrease of at least 100 points in CDAI from Baseline.
CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease.
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Timepoint [6]
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Baseline and Week 12
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Secondary outcome [7]
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Percentage of Participants With Clinical Remission Per CDAI at Week 4
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Assessment method [7]
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CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. Clinical remission is defined as CDAI score less than 150.
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Timepoint [7]
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Week 4
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Secondary outcome [8]
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Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During the 12-Week Induction Period
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Assessment method [8]
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This was assessed by reviewing participant's hospitalization data.
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Timepoint [8]
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12 weeks
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Secondary outcome [9]
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Percentage of Participants With Resolution of Extra-Intestinal Manifestation (EIMs) at Week 12
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Assessment method [9]
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EIMs are defined as manifestations of Crohn's disease in areas of the body other than the digestive tract, including eyes, skin, joints, mouth, and liver.
Only participants with any EIM present at Baseline were included in the analysis of resolution of EIMs. Resolution of EIMs was defined as absence of all EIMs at the Week 12 visit.
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Timepoint [9]
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Week 12
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Secondary outcome [10]
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Percentage of Participants With Clinical Remission Per PROs at Week 4
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Assessment method [10]
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Clinical remission per PROs was defined as average daily very soft or liquid SF = 2.8 and average daily APS = 1.0 and neither worse than Baseline.
Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).
The average daily very soft or liquid SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 4 visit.
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Timepoint [10]
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Week 4
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Secondary outcome [11]
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Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease and Achieved Clinical Remission Per PROs at Week 12
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Assessment method [11]
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Corticosteroid-free clinical remission is defined as participants who discontinued corticosteroid use for CD and achieved clinical remission per PROs at Week 12, assessed for participants taking corticosteroids for CD at Baseline.
Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) = 2.8 and average daily APS = 1.0 and neither worse than Baseline.
Participants recorded APS and the number of liquid or very soft SF daily in an electronic diary. Abdominal pain was rated on a scale from 0 (none) to 3 (severe).
The average daily liquid or very soft SF and APS were calculated using the 4-7 most recent useable days of patient-reported outcomes (i.e., excluding days with missing entries or associated with endoscopy procedures) out of the last 14 days prior to the Week 12 visit.
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Timepoint [11]
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Week 12
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of CD for at least 3 months prior to Baseline.
- Confirmed diagnosis of moderate to severe CD as assessed by stool frequency (SF),
abdominal pain (AP) score.
- Evidence of mucosal inflammation based on the Simplified Endoscopic Score for Crohn's
disease (SES-CD) on an endoscopy confirmed by a central reader.
- Demonstrated an inadequate response or intolerance to one or more conventional and/or
biologic therapies (oral locally acting steroids, intravenous or oral corticosteroids,
immunosuppressants or biologic therapies for CD), in the opinion of the investigator.
- Note: Participants who have had inadequate response or intolerance to
conventional therapy who have received prior biologic may be enrolled; however,
participants must have discontinued the biologic for reasons other than
inadequate response or intolerance (e.g., change of insurance, well controlled
disease).
- If female, participant must meet the contraception recommendations.
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Minimum age
18
Years
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Maximum age
75
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Participant with a current diagnosis of ulcerative colitis or indeterminate colitis.
- Participant not on stable doses of CD related antibiotics, oral aminosalicylates,
corticosteroids or methotrexate (MTX).
- Participant with the following ongoing known complications of CD: abscess (abdominal
or peri-anal), symptomatic bowel strictures, fulminant colitis, toxic megacolon, > 2
entire missing segments of the following 5 segments: terminal ileum, right colon,
transverse colon, sigmoid and left colon, and rectum, or any other manifestation that
might require surgery while enrolled in the study.
- Participant with ostomy or ileoanal pouch.
- Participant diagnosed with conditions that could interfere with drug absorption
including but not limited to short gut or short bowel syndrome.
- Screening laboratory and other analyses show abnormal results.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/12/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/01/2022
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Sample size
Target
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Accrual to date
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Final
526
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Concord Repatriation General Hospital /ID# 171512 - Concord
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Recruitment hospital [2]
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Coral Sea Clinical Research institute /ID# 212988 - North Mackay
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Mater Misericordiae Limited /ID# 204909 - South Brisbane
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Royal Adelaide Hospital /ID# 171514 - Adelaide
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Box Hill Hospital /ID# 203736 - Box Hill
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Fiona Stanley Hospital /ID# 171513 - Murdoch
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2139 - Concord
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4740 - North Mackay
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4101 - South Brisbane
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5000 - Adelaide
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3128 - Box Hill
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6150 - Murdoch
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Recruitment outside Australia
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0
0
Concepción
Query!
Country [62]
0
0
Chile
Query!
State/province [62]
0
0
Providencia
Query!
Country [63]
0
0
Chile
Query!
State/province [63]
0
0
Santiago
Query!
Country [64]
0
0
China
Query!
State/province [64]
0
0
Fujian
Query!
Country [65]
0
0
China
Query!
State/province [65]
0
0
Guangdong
Query!
Country [66]
0
0
China
Query!
State/province [66]
0
0
Hubei
Query!
Country [67]
0
0
China
Query!
State/province [67]
0
0
Jiangsu
Query!
Country [68]
0
0
China
Query!
State/province [68]
0
0
Jiangxi
Query!
Country [69]
0
0
China
Query!
State/province [69]
0
0
Jilin
Query!
Country [70]
0
0
China
Query!
State/province [70]
0
0
Shanghai
Query!
Country [71]
0
0
China
Query!
State/province [71]
0
0
Zhejiang
Query!
Country [72]
0
0
China
Query!
State/province [72]
0
0
Beijing
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Changsha
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Tianjin
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Wuhan
Query!
Country [76]
0
0
Colombia
Query!
State/province [76]
0
0
Antioquia
Query!
Country [77]
0
0
Colombia
Query!
State/province [77]
0
0
Medellin
Query!
Country [78]
0
0
Croatia
Query!
State/province [78]
0
0
Grad Zagreb
Query!
Country [79]
0
0
Croatia
Query!
State/province [79]
0
0
Split
Query!
Country [80]
0
0
Croatia
Query!
State/province [80]
0
0
Zadar
Query!
Country [81]
0
0
Czechia
Query!
State/province [81]
0
0
Ceske Budejovice
Query!
Country [82]
0
0
Czechia
Query!
State/province [82]
0
0
Hradec Kralove
Query!
Country [83]
0
0
Czechia
Query!
State/province [83]
0
0
Ostrava
Query!
Country [84]
0
0
Czechia
Query!
State/province [84]
0
0
Praha
Query!
Country [85]
0
0
Denmark
Query!
State/province [85]
0
0
Hovedstaden
Query!
Country [86]
0
0
Denmark
Query!
State/province [86]
0
0
Sjælland
Query!
Country [87]
0
0
Egypt
Query!
State/province [87]
0
0
Alexandria
Query!
Country [88]
0
0
Egypt
Query!
State/province [88]
0
0
Cairo
Query!
Country [89]
0
0
Egypt
Query!
State/province [89]
0
0
Menoufiya
Query!
Country [90]
0
0
Estonia
Query!
State/province [90]
0
0
Tallinn
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
La Tronche
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Nantes
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Valenciennes
Query!
Country [94]
0
0
Germany
Query!
State/province [94]
0
0
Baden-Wuerttemberg
Query!
Country [95]
0
0
Germany
Query!
State/province [95]
0
0
Bayern
Query!
Country [96]
0
0
Germany
Query!
State/province [96]
0
0
Hessen
Query!
Country [97]
0
0
Germany
Query!
State/province [97]
0
0
Saarland
Query!
Country [98]
0
0
Germany
Query!
State/province [98]
0
0
Schleswig-Holstein
Query!
Country [99]
0
0
Germany
Query!
State/province [99]
0
0
Berlin
Query!
Country [100]
0
0
Germany
Query!
State/province [100]
0
0
Essen
Query!
Country [101]
0
0
Germany
Query!
State/province [101]
0
0
Frankfurt am Main
Query!
Country [102]
0
0
Germany
Query!
State/province [102]
0
0
Halle (Saale)
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Muenster
Query!
Country [104]
0
0
Greece
Query!
State/province [104]
0
0
Attiki
Query!
Country [105]
0
0
Greece
Query!
State/province [105]
0
0
Kriti
Query!
Country [106]
0
0
Greece
Query!
State/province [106]
0
0
Thessaloniki
Query!
Country [107]
0
0
Hong Kong
Query!
State/province [107]
0
0
Hong Kong
Query!
Country [108]
0
0
Hungary
Query!
State/province [108]
0
0
Baranya
Query!
Country [109]
0
0
Hungary
Query!
State/province [109]
0
0
Borsod-Abauj-Zemplen
Query!
Country [110]
0
0
Hungary
Query!
State/province [110]
0
0
Hajdu-Bihar
Query!
Country [111]
0
0
Hungary
Query!
State/province [111]
0
0
Heves
Query!
Country [112]
0
0
Hungary
Query!
State/province [112]
0
0
Komarom-Esztergom
Query!
Country [113]
0
0
Hungary
Query!
State/province [113]
0
0
Pest
Query!
Country [114]
0
0
Hungary
Query!
State/province [114]
0
0
Budapest
Query!
Country [115]
0
0
Hungary
Query!
State/province [115]
0
0
Debrecen
Query!
Country [116]
0
0
Hungary
Query!
State/province [116]
0
0
Kistarcsa
Query!
Country [117]
0
0
Hungary
Query!
State/province [117]
0
0
Szekesfehervar
Query!
Country [118]
0
0
Ireland
Query!
State/province [118]
0
0
Cork
Query!
Country [119]
0
0
Israel
Query!
State/province [119]
0
0
HaDarom
Query!
Country [120]
0
0
Israel
Query!
State/province [120]
0
0
Tel-Aviv
Query!
Country [121]
0
0
Israel
Query!
State/province [121]
0
0
Be'Er Ya'Akov
Query!
Country [122]
0
0
Israel
Query!
State/province [122]
0
0
Jerusalem
Query!
Country [123]
0
0
Israel
Query!
State/province [123]
0
0
Petakh Tikva
Query!
Country [124]
0
0
Israel
Query!
State/province [124]
0
0
Rehovot
Query!
Country [125]
0
0
Italy
Query!
State/province [125]
0
0
Lazio
Query!
Country [126]
0
0
Italy
Query!
State/province [126]
0
0
Milano
Query!
Country [127]
0
0
Italy
Query!
State/province [127]
0
0
Roma
Query!
Country [128]
0
0
Italy
Query!
State/province [128]
0
0
Verona
Query!
Country [129]
0
0
Italy
Query!
State/province [129]
0
0
Bologna
Query!
Country [130]
0
0
Italy
Query!
State/province [130]
0
0
Catania
Query!
Country [131]
0
0
Italy
Query!
State/province [131]
0
0
Genova
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Modena
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Palermo
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Pisa
Query!
Country [135]
0
0
Japan
Query!
State/province [135]
0
0
Aichi
Query!
Country [136]
0
0
Japan
Query!
State/province [136]
0
0
Aomori
Query!
Country [137]
0
0
Japan
Query!
State/province [137]
0
0
Chiba
Query!
Country [138]
0
0
Japan
Query!
State/province [138]
0
0
Fukuoka
Query!
Country [139]
0
0
Japan
Query!
State/province [139]
0
0
Gunma
Query!
Country [140]
0
0
Japan
Query!
State/province [140]
0
0
Hiroshima
Query!
Country [141]
0
0
Japan
Query!
State/province [141]
0
0
Hokkaido
Query!
Country [142]
0
0
Japan
Query!
State/province [142]
0
0
Hyogo
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Ishikawa
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Iwate
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Kagoshima
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Kanagawa
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Kyoto
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Mie
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Miyagi
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Nara
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Niigata
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Oita
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Okayama
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Osaka
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Saitama
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Shiga
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Shizuoka
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Tokyo
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Toyama
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Wakayama
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Yamagata
Query!
Country [162]
0
0
Korea, Republic of
Query!
State/province [162]
0
0
Gyeonggido
Query!
Country [163]
0
0
Korea, Republic of
Query!
State/province [163]
0
0
Seoul Teugbyeolsi
Query!
Country [164]
0
0
Korea, Republic of
Query!
State/province [164]
0
0
Busan
Query!
Country [165]
0
0
Korea, Republic of
Query!
State/province [165]
0
0
Daegu
Query!
Country [166]
0
0
Korea, Republic of
Query!
State/province [166]
0
0
Seoul
Query!
Country [167]
0
0
Latvia
Query!
State/province [167]
0
0
Riga
Query!
Country [168]
0
0
Lithuania
Query!
State/province [168]
0
0
Kaunas
Query!
Country [169]
0
0
Lithuania
Query!
State/province [169]
0
0
Vilnius
Query!
Country [170]
0
0
Malaysia
Query!
State/province [170]
0
0
Kedah
Query!
Country [171]
0
0
Malaysia
Query!
State/province [171]
0
0
Selangor
Query!
Country [172]
0
0
Malaysia
Query!
State/province [172]
0
0
Kelantan
Query!
Country [173]
0
0
Mexico
Query!
State/province [173]
0
0
Durango
Query!
Country [174]
0
0
Mexico
Query!
State/province [174]
0
0
Guanajuato
Query!
Country [175]
0
0
Mexico
Query!
State/province [175]
0
0
Jalisco
Query!
Country [176]
0
0
Netherlands
Query!
State/province [176]
0
0
Gelderland
Query!
Country [177]
0
0
Netherlands
Query!
State/province [177]
0
0
Limburg
Query!
Country [178]
0
0
Netherlands
Query!
State/province [178]
0
0
Amsterdam
Query!
Country [179]
0
0
Netherlands
Query!
State/province [179]
0
0
Enschede
Query!
Country [180]
0
0
Poland
Query!
State/province [180]
0
0
Dolnoslaskie
Query!
Country [181]
0
0
Poland
Query!
State/province [181]
0
0
Malopolskie
Query!
Country [182]
0
0
Poland
Query!
State/province [182]
0
0
Mazowieckie
Query!
Country [183]
0
0
Portugal
Query!
State/province [183]
0
0
Braga
Query!
Country [184]
0
0
Portugal
Query!
State/province [184]
0
0
Porto
Query!
Country [185]
0
0
Portugal
Query!
State/province [185]
0
0
Viana Do Castelo
Query!
Country [186]
0
0
Portugal
Query!
State/province [186]
0
0
Almada
Query!
Country [187]
0
0
Puerto Rico
Query!
State/province [187]
0
0
San Juan
Query!
Country [188]
0
0
Romania
Query!
State/province [188]
0
0
Bucuresti
Query!
Country [189]
0
0
Romania
Query!
State/province [189]
0
0
Cluj
Query!
Country [190]
0
0
Romania
Query!
State/province [190]
0
0
Timi?oara
Query!
Country [191]
0
0
Russian Federation
Query!
State/province [191]
0
0
Kaliningradskaya Oblast
Query!
Country [192]
0
0
Russian Federation
Query!
State/province [192]
0
0
Novosibirskaya Oblast
Query!
Country [193]
0
0
Russian Federation
Query!
State/province [193]
0
0
Permskiy Kray
Query!
Country [194]
0
0
Russian Federation
Query!
State/province [194]
0
0
Stavropol Skiy Kray
Query!
Country [195]
0
0
Russian Federation
Query!
State/province [195]
0
0
Tatarstan, Respublika
Query!
Country [196]
0
0
Russian Federation
Query!
State/province [196]
0
0
Moscow
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Murmansk
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Petrozavodsk
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Pushkin
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Saint Petersburg
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
St. Petersburg
Query!
Country [202]
0
0
Serbia
Query!
State/province [202]
0
0
Beograd
Query!
Country [203]
0
0
Serbia
Query!
State/province [203]
0
0
Sumadijski Okrug
Query!
Country [204]
0
0
Serbia
Query!
State/province [204]
0
0
Vojvodina
Query!
Country [205]
0
0
Singapore
Query!
State/province [205]
0
0
Singapore
Query!
Country [206]
0
0
Slovakia
Query!
State/province [206]
0
0
Banska Bystrica
Query!
Country [207]
0
0
Slovakia
Query!
State/province [207]
0
0
Nitra
Query!
Country [208]
0
0
Slovenia
Query!
State/province [208]
0
0
Ljubljana
Query!
Country [209]
0
0
South Africa
Query!
State/province [209]
0
0
Free State
Query!
Country [210]
0
0
South Africa
Query!
State/province [210]
0
0
Gauteng
Query!
Country [211]
0
0
South Africa
Query!
State/province [211]
0
0
Western Cape
Query!
Country [212]
0
0
Spain
Query!
State/province [212]
0
0
Illes Balears
Query!
Country [213]
0
0
Spain
Query!
State/province [213]
0
0
Navarra
Query!
Country [214]
0
0
Spain
Query!
State/province [214]
0
0
A Coruna
Query!
Country [215]
0
0
Spain
Query!
State/province [215]
0
0
Barcelona
Query!
Country [216]
0
0
Spain
Query!
State/province [216]
0
0
Girona
Query!
Country [217]
0
0
Spain
Query!
State/province [217]
0
0
Huelva
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Madrid
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Salamanca
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Sevilla
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Valencia
Query!
Country [222]
0
0
Sweden
Query!
State/province [222]
0
0
Hallands Lan
Query!
Country [223]
0
0
Sweden
Query!
State/province [223]
0
0
Stockholms Lan
Query!
Country [224]
0
0
Sweden
Query!
State/province [224]
0
0
Vastra Gotalands Lan
Query!
Country [225]
0
0
Switzerland
Query!
State/province [225]
0
0
Zuerich
Query!
Country [226]
0
0
Switzerland
Query!
State/province [226]
0
0
Bern
Query!
Country [227]
0
0
Taiwan
Query!
State/province [227]
0
0
Taichung City
Query!
Country [228]
0
0
Taiwan
Query!
State/province [228]
0
0
Taichung
Query!
Country [229]
0
0
Taiwan
Query!
State/province [229]
0
0
Taipei City
Query!
Country [230]
0
0
Turkey
Query!
State/province [230]
0
0
Istanbul
Query!
Country [231]
0
0
Turkey
Query!
State/province [231]
0
0
Kayseri
Query!
Country [232]
0
0
Turkey
Query!
State/province [232]
0
0
Ankara
Query!
Country [233]
0
0
Turkey
Query!
State/province [233]
0
0
Battalgazi/malatya
Query!
Country [234]
0
0
Turkey
Query!
State/province [234]
0
0
Hatay
Query!
Country [235]
0
0
Turkey
Query!
State/province [235]
0
0
Mersin
Query!
Country [236]
0
0
Turkey
Query!
State/province [236]
0
0
Sisli
Query!
Country [237]
0
0
Turkey
Query!
State/province [237]
0
0
Yenimahalle
Query!
Country [238]
0
0
Ukraine
Query!
State/province [238]
0
0
Kyivska Oblast
Query!
Country [239]
0
0
Ukraine
Query!
State/province [239]
0
0
Kharkiv
Query!
Country [240]
0
0
Ukraine
Query!
State/province [240]
0
0
Kyiv
Query!
Country [241]
0
0
Ukraine
Query!
State/province [241]
0
0
Lviv
Query!
Country [242]
0
0
Ukraine
Query!
State/province [242]
0
0
Vinnytsia
Query!
Country [243]
0
0
United Kingdom
Query!
State/province [243]
0
0
Antrim
Query!
Country [244]
0
0
United Kingdom
Query!
State/province [244]
0
0
Cheshire West And Chester
Query!
Country [245]
0
0
United Kingdom
Query!
State/province [245]
0
0
Bath
Query!
Country [246]
0
0
United Kingdom
Query!
State/province [246]
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Birmingham
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Country [247]
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United Kingdom
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State/province [247]
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Dudley
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Country [248]
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United Kingdom
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State/province [248]
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London
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Country [249]
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United Kingdom
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State/province [249]
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Newcastle Upon Tyne
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Country [250]
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United Kingdom
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State/province [250]
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Stockport
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Country [251]
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United Kingdom
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State/province [251]
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Taunton
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Country [252]
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United Kingdom
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State/province [252]
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Tooting
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Country [253]
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United Kingdom
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State/province [253]
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Wolverhampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
to placebo as induction therapy in adults with moderately and severely active Crohn's disease
(CD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03345849
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Fax
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03345849
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