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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/NCT03345836
Registration number
NCT03345836
Ethics application status
Date submitted
15/11/2017
Date registered
17/11/2017
Date last updated
15/08/2022
Titles & IDs
Public title
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
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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 Biologic Therapy
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Secondary ID [1]
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2017-001226-18
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Secondary ID [2]
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M14-431
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Universal Trial Number (UTN)
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Trial acronym
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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 - Matching Placebo for Upadacitinib
Treatment: Drugs - Upadacitinib
Placebo Comparator: Part 1 (Double-blind): Placebo - Participants received upadacitinib matching placebo tablets, orally, once daily (QD) for 12 weeks during the Double-blind (DB) Induction Period.
Experimental: Part 1 (Double-blind): Upadacitinib 45 mg - Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the DB Induction Period.
Experimental: Part 2 (Open-label): Upadacitinib 45 mg - Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks during the Open-label (OL) Induction Period.
Experimental: Part 3 (Extended Treatment DB): Upadacitinib 45 mg From Part 1 DB Placebo - Participants received upadacitinib 45 mg tablets, orally, QD for 12 weeks (until Week 24) during the Extended Treatment (ET) Period. Participants who received placebo in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Experimental: Part 3 (Extended Treatment DB): Upadacitinib 30 mg From Part 1 DB Upadacitinib 45 mg - Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received DB upadacitinib 45 mg in Part 1 and did not achieve clinical response at Week 12 were included in this group.
Experimental: Part 3 (Extended Treatment OL): Upadacitinib 30 mg From Part 2 OL Upadacitinib 45 mg - Participants received upadacitinib 30 mg tablets, orally, QD for 12 weeks (until Week 24) during the ET Period. Participants who received OL upadacitinib 45 mg during Part 2 and did not achieve clinical response at Week 12 were included in this group.
Treatment: Drugs: Matching Placebo for Upadacitinib
Matching placebo tablets
Treatment: Drugs: Upadacitinib
Upadacitinib tablets
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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 CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on non-responder imputation incorporating multiple imputation to handle missing data due to COVID-19 (NRI-C).
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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 Endoscopic Response at Week 12
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Assessment method [2]
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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 of the induction study, at least a 2-point reduction from Baseline), as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
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Timepoint [2]
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Baseline to Week 12
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Primary outcome [3]
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Number of Participants With Adverse Events
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Assessment method [3]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
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Timepoint [3]
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From first dose of study drug until 30 days following last dose of study drug (up to approximately 28 weeks)
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Secondary outcome [1]
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Percentage of Participants With Clinical Remission Per Patient-Reported Outcomes (PROs) at Week 12
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Assessment method [1]
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Clinical remission per PROs was defined as average daily very soft or liquid stool frequency (SF) =2.8 and average daily abdominal pain (AP) score =1.0 and both not greater than Baseline. The number of soft or liquid stools and abdominal pain rated on a scale of 0=none to 3=severe were recorded in an electronic diary. Results were based on NRI-C.
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Timepoint [1]
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Baseline to Week 12
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Secondary outcome [2]
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Percentage of Participants With Endoscopic Remission at Week 12
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Assessment method [2]
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Endoscopic remission was defined per SES-CD. SES-CD =4 and at least 2-point reduction from Baseline and no subscore >1 in any individual variable, as scored by Central Reviewer. SES-CD is calculated based on the sum of individual segment values for four endoscopic variables (presence and size of ulcers, ulcerated surface, affected surface and presence of narrowing). Each variable in each segment is scored 0 to 3 resulting in SES-CD values ranging from 0 to 56 with higher scores indicating more severe disease. Results were based on NRI-C.
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Timepoint [2]
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Baseline to Week 12
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Secondary outcome [3]
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Percentage of Participants Who Discontinued Corticosteroid Use for Crohn's Disease (CD) and Achieved Clinical Remission Per CDAI at Week 12, in Participants Taking Corticosteroids at Baseline
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Assessment method [3]
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As prespecified in the protocol, this outcome measure was planned to be assessed in participants taking corticosteroids at Baseline. Clinical remission per CDAI: CDAI <150. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
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Timepoint [3]
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Week 12
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Secondary outcome [4]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Total Score at Week 12
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Assessment method [4]
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The FACIT-F questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. The responses to the 13 items on the FACIT-F questionnaire are each measured on a 5-point Likert scale. The responses to the answers are the following: 0= not at all; 1= a little bit; 2= somewhat; 3= quite a bit; 4=very much. Thus, the total score ranges from 0 to 52. High scores represent less fatigue. 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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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 12
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Assessment method [5]
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The IBDQ is a disease-specific instrument composed of 32 Likert-scaled items. The IBDQ scale contains 4 component subscales: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). Each item is scored on a 7-point scale where: 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 [5]
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Baseline and Week 12
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Secondary outcome [6]
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Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 2
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Assessment method [6]
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CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 2. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
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Timepoint [6]
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Baseline to Week 2
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Secondary outcome [7]
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Percentage of Participants Achieving Clinical Response 100 (CR-100) at Week 12
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Assessment method [7]
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CR-100 is defined as a decrease of at least 100 points in CDAI from Baseline at Week 12. The CDAI is used to evaluate the activity of Crohn's disease. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to about 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Percentage of Participants With Clinical Remission Per Crohn's Disease Activity Index (CDAI) at Week 4
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Assessment method [8]
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The CDAI was used to evaluate the activity of Crohn's disease. Clinical remission per CDAI is defined as CDAI <150. The CDAI is calculated on the basis of a one-week evaluation of 8 items: frequency of liquid or very soft stool, abdominal pain, complications of Crohn's disease (e.g., uveitis, arthritis, fistula, and abscess), abdominal mass, hematocrit, body weight, use of antidiarrheals, and general condition. Total score ranges from 0 to 600. Higher CDAI scores indicate more severe disease. CDAI scores below 150 represent remission and scores over 450 represent very severe Crohn's disease. Results were based on NRI-C.
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Timepoint [8]
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Week 4
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Secondary outcome [9]
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Percentage of Participants With Hospitalizations Due to Crohn's Disease (CD) During Part 1 (12-week Double-blind Induction Period)
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Assessment method [9]
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Timepoint [9]
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Up to Week 12 in Part 1: Double-blind Induction Period
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Secondary outcome [10]
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Percentage of Participants With Resolution of Extra-Intestinal Manifestations (EIMs) at Week 12, in Participants With EIMs at Baseline
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Assessment method [10]
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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. Results were based on NRI-C.
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Timepoint [10]
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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 any biologic therapy for
infliximab, adalimumab, certolizumab pegol, vedolizumab, and ustekinumab.
- 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, 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 protocol pre-specified 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
29/11/2017
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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
11/08/2021
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Sample size
Target
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Accrual to date
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Final
624
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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# 171509 - Concord
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Recruitment hospital [2]
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Coral Sea Clinical Research institute /ID# 212987 - North Mackay
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Mater Misericordiae Limited /ID# 204908 - South Brisbane
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Royal Adelaide Hospital /ID# 171511 - Adelaide
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Box Hill Hospital /ID# 203734 - Box Hill
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Fiona Stanley Hospital /ID# 171510 - Murdoch
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Recruitment postcode(s) [1]
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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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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment outside Australia
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Zhejiang
Query!
Country [73]
0
0
China
Query!
State/province [73]
0
0
Beijing
Query!
Country [74]
0
0
China
Query!
State/province [74]
0
0
Changsha
Query!
Country [75]
0
0
China
Query!
State/province [75]
0
0
Guangzhou
Query!
Country [76]
0
0
China
Query!
State/province [76]
0
0
Tianjin
Query!
Country [77]
0
0
China
Query!
State/province [77]
0
0
Wuhan
Query!
Country [78]
0
0
Colombia
Query!
State/province [78]
0
0
Antioquia
Query!
Country [79]
0
0
Croatia
Query!
State/province [79]
0
0
Grad Zagreb
Query!
Country [80]
0
0
Croatia
Query!
State/province [80]
0
0
Split
Query!
Country [81]
0
0
Croatia
Query!
State/province [81]
0
0
Zadar
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
Praha
Query!
Country [84]
0
0
Czechia
Query!
State/province [84]
0
0
Trebovice
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
Estonia
Query!
State/province [89]
0
0
Tartumaa
Query!
Country [90]
0
0
France
Query!
State/province [90]
0
0
Alpes-Maritimes
Query!
Country [91]
0
0
France
Query!
State/province [91]
0
0
Auvergne-Rhone-Alpes
Query!
Country [92]
0
0
France
Query!
State/province [92]
0
0
Gironde
Query!
Country [93]
0
0
France
Query!
State/province [93]
0
0
Hauts-de-France
Query!
Country [94]
0
0
France
Query!
State/province [94]
0
0
Herault
Query!
Country [95]
0
0
France
Query!
State/province [95]
0
0
Ile-de-France
Query!
Country [96]
0
0
France
Query!
State/province [96]
0
0
Loire
Query!
Country [97]
0
0
France
Query!
State/province [97]
0
0
Meurthe-et-Moselle
Query!
Country [98]
0
0
France
Query!
State/province [98]
0
0
Somme
Query!
Country [99]
0
0
France
Query!
State/province [99]
0
0
Chambray Les Tours
Query!
Country [100]
0
0
France
Query!
State/province [100]
0
0
Creteil
Query!
Country [101]
0
0
France
Query!
State/province [101]
0
0
Nimes Cedex
Query!
Country [102]
0
0
France
Query!
State/province [102]
0
0
Toulouse
Query!
Country [103]
0
0
Germany
Query!
State/province [103]
0
0
Baden-Wuerttemberg
Query!
Country [104]
0
0
Germany
Query!
State/province [104]
0
0
Bayern
Query!
Country [105]
0
0
Germany
Query!
State/province [105]
0
0
Hessen
Query!
Country [106]
0
0
Germany
Query!
State/province [106]
0
0
Saarland
Query!
Country [107]
0
0
Germany
Query!
State/province [107]
0
0
Schleswig-Holstein
Query!
Country [108]
0
0
Germany
Query!
State/province [108]
0
0
Berlin
Query!
Country [109]
0
0
Germany
Query!
State/province [109]
0
0
Essen
Query!
Country [110]
0
0
Germany
Query!
State/province [110]
0
0
Frankfurt am Main
Query!
Country [111]
0
0
Germany
Query!
State/province [111]
0
0
Halle (Saale)
Query!
Country [112]
0
0
Germany
Query!
State/province [112]
0
0
Muenster
Query!
Country [113]
0
0
Greece
Query!
State/province [113]
0
0
Attiki
Query!
Country [114]
0
0
Greece
Query!
State/province [114]
0
0
Kriti
Query!
Country [115]
0
0
Greece
Query!
State/province [115]
0
0
Athens
Query!
Country [116]
0
0
Greece
Query!
State/province [116]
0
0
Thessaloniki
Query!
Country [117]
0
0
Hong Kong
Query!
State/province [117]
0
0
Hong Kong
Query!
Country [118]
0
0
Hungary
Query!
State/province [118]
0
0
Borsod-Abauj-Zemplen
Query!
Country [119]
0
0
Hungary
Query!
State/province [119]
0
0
Heves
Query!
Country [120]
0
0
Hungary
Query!
State/province [120]
0
0
Pest
Query!
Country [121]
0
0
Hungary
Query!
State/province [121]
0
0
Budapest
Query!
Country [122]
0
0
Hungary
Query!
State/province [122]
0
0
Debrecen
Query!
Country [123]
0
0
Hungary
Query!
State/province [123]
0
0
Szekesfehervar
Query!
Country [124]
0
0
Ireland
Query!
State/province [124]
0
0
Cork
Query!
Country [125]
0
0
Israel
Query!
State/province [125]
0
0
HaDarom
Query!
Country [126]
0
0
Israel
Query!
State/province [126]
0
0
Tel-Aviv
Query!
Country [127]
0
0
Israel
Query!
State/province [127]
0
0
Ashkelon
Query!
Country [128]
0
0
Israel
Query!
State/province [128]
0
0
Be'Er Ya'Akov
Query!
Country [129]
0
0
Israel
Query!
State/province [129]
0
0
Jerusalem
Query!
Country [130]
0
0
Israel
Query!
State/province [130]
0
0
Petakh Tikva
Query!
Country [131]
0
0
Israel
Query!
State/province [131]
0
0
Rehovot
Query!
Country [132]
0
0
Italy
Query!
State/province [132]
0
0
Calabria
Query!
Country [133]
0
0
Italy
Query!
State/province [133]
0
0
Lazio
Query!
Country [134]
0
0
Italy
Query!
State/province [134]
0
0
Milano
Query!
Country [135]
0
0
Italy
Query!
State/province [135]
0
0
Roma
Query!
Country [136]
0
0
Italy
Query!
State/province [136]
0
0
Verona
Query!
Country [137]
0
0
Italy
Query!
State/province [137]
0
0
Bologna
Query!
Country [138]
0
0
Italy
Query!
State/province [138]
0
0
Catania
Query!
Country [139]
0
0
Italy
Query!
State/province [139]
0
0
Genova
Query!
Country [140]
0
0
Italy
Query!
State/province [140]
0
0
Modena
Query!
Country [141]
0
0
Italy
Query!
State/province [141]
0
0
Palermo
Query!
Country [142]
0
0
Italy
Query!
State/province [142]
0
0
Pisa
Query!
Country [143]
0
0
Japan
Query!
State/province [143]
0
0
Aichi
Query!
Country [144]
0
0
Japan
Query!
State/province [144]
0
0
Aomori
Query!
Country [145]
0
0
Japan
Query!
State/province [145]
0
0
Chiba
Query!
Country [146]
0
0
Japan
Query!
State/province [146]
0
0
Fukuoka
Query!
Country [147]
0
0
Japan
Query!
State/province [147]
0
0
Gunma
Query!
Country [148]
0
0
Japan
Query!
State/province [148]
0
0
Hiroshima
Query!
Country [149]
0
0
Japan
Query!
State/province [149]
0
0
Hokkaido
Query!
Country [150]
0
0
Japan
Query!
State/province [150]
0
0
Hyogo
Query!
Country [151]
0
0
Japan
Query!
State/province [151]
0
0
Ishikawa
Query!
Country [152]
0
0
Japan
Query!
State/province [152]
0
0
Iwate
Query!
Country [153]
0
0
Japan
Query!
State/province [153]
0
0
Kagoshima
Query!
Country [154]
0
0
Japan
Query!
State/province [154]
0
0
Kyoto
Query!
Country [155]
0
0
Japan
Query!
State/province [155]
0
0
Mie
Query!
Country [156]
0
0
Japan
Query!
State/province [156]
0
0
Miyagi
Query!
Country [157]
0
0
Japan
Query!
State/province [157]
0
0
Nara
Query!
Country [158]
0
0
Japan
Query!
State/province [158]
0
0
Niigata
Query!
Country [159]
0
0
Japan
Query!
State/province [159]
0
0
Oita
Query!
Country [160]
0
0
Japan
Query!
State/province [160]
0
0
Okayama
Query!
Country [161]
0
0
Japan
Query!
State/province [161]
0
0
Osaka
Query!
Country [162]
0
0
Japan
Query!
State/province [162]
0
0
Saitama
Query!
Country [163]
0
0
Japan
Query!
State/province [163]
0
0
Shiga
Query!
Country [164]
0
0
Japan
Query!
State/province [164]
0
0
Shizuoka
Query!
Country [165]
0
0
Japan
Query!
State/province [165]
0
0
Tokyo
Query!
Country [166]
0
0
Japan
Query!
State/province [166]
0
0
Toyama
Query!
Country [167]
0
0
Japan
Query!
State/province [167]
0
0
Wakayama
Query!
Country [168]
0
0
Japan
Query!
State/province [168]
0
0
Yamagata
Query!
Country [169]
0
0
Korea, Republic of
Query!
State/province [169]
0
0
Gyeonggido
Query!
Country [170]
0
0
Korea, Republic of
Query!
State/province [170]
0
0
Seoul Teugbyeolsi
Query!
Country [171]
0
0
Korea, Republic of
Query!
State/province [171]
0
0
Busan
Query!
Country [172]
0
0
Korea, Republic of
Query!
State/province [172]
0
0
Daegu
Query!
Country [173]
0
0
Korea, Republic of
Query!
State/province [173]
0
0
Seoul
Query!
Country [174]
0
0
Latvia
Query!
State/province [174]
0
0
Riga
Query!
Country [175]
0
0
Lithuania
Query!
State/province [175]
0
0
Kaunas
Query!
Country [176]
0
0
Lithuania
Query!
State/province [176]
0
0
Vilnius
Query!
Country [177]
0
0
Malaysia
Query!
State/province [177]
0
0
Kedah
Query!
Country [178]
0
0
Malaysia
Query!
State/province [178]
0
0
Selangor
Query!
Country [179]
0
0
Mexico
Query!
State/province [179]
0
0
Durango
Query!
Country [180]
0
0
Mexico
Query!
State/province [180]
0
0
Guanajuato
Query!
Country [181]
0
0
Mexico
Query!
State/province [181]
0
0
Jalisco
Query!
Country [182]
0
0
Netherlands
Query!
State/province [182]
0
0
Gelderland
Query!
Country [183]
0
0
Netherlands
Query!
State/province [183]
0
0
Limburg
Query!
Country [184]
0
0
Netherlands
Query!
State/province [184]
0
0
Amsterdam
Query!
Country [185]
0
0
Netherlands
Query!
State/province [185]
0
0
Enschede
Query!
Country [186]
0
0
Poland
Query!
State/province [186]
0
0
Dolnoslaskie
Query!
Country [187]
0
0
Poland
Query!
State/province [187]
0
0
Malopolskie
Query!
Country [188]
0
0
Poland
Query!
State/province [188]
0
0
Mazowieckie
Query!
Country [189]
0
0
Portugal
Query!
State/province [189]
0
0
Braga
Query!
Country [190]
0
0
Portugal
Query!
State/province [190]
0
0
Porto
Query!
Country [191]
0
0
Portugal
Query!
State/province [191]
0
0
Viana Do Castelo
Query!
Country [192]
0
0
Portugal
Query!
State/province [192]
0
0
Almada
Query!
Country [193]
0
0
Puerto Rico
Query!
State/province [193]
0
0
San Juan
Query!
Country [194]
0
0
Romania
Query!
State/province [194]
0
0
Bucuresti
Query!
Country [195]
0
0
Romania
Query!
State/province [195]
0
0
Cluj
Query!
Country [196]
0
0
Romania
Query!
State/province [196]
0
0
Timi?oara
Query!
Country [197]
0
0
Russian Federation
Query!
State/province [197]
0
0
Kaliningradskaya Oblast
Query!
Country [198]
0
0
Russian Federation
Query!
State/province [198]
0
0
Novosibirskaya Oblast
Query!
Country [199]
0
0
Russian Federation
Query!
State/province [199]
0
0
Permskiy Kray
Query!
Country [200]
0
0
Russian Federation
Query!
State/province [200]
0
0
Stavropol Skiy Kray
Query!
Country [201]
0
0
Russian Federation
Query!
State/province [201]
0
0
Tatarstan, Respublika
Query!
Country [202]
0
0
Russian Federation
Query!
State/province [202]
0
0
Moscow
Query!
Country [203]
0
0
Russian Federation
Query!
State/province [203]
0
0
Murmansk
Query!
Country [204]
0
0
Russian Federation
Query!
State/province [204]
0
0
Petrozavodsk
Query!
Country [205]
0
0
Russian Federation
Query!
State/province [205]
0
0
Pushkin
Query!
Country [206]
0
0
Russian Federation
Query!
State/province [206]
0
0
Saint Petersburg
Query!
Country [207]
0
0
Russian Federation
Query!
State/province [207]
0
0
St. Petersburg
Query!
Country [208]
0
0
Serbia
Query!
State/province [208]
0
0
Beograd
Query!
Country [209]
0
0
Serbia
Query!
State/province [209]
0
0
Sumadijski Okrug
Query!
Country [210]
0
0
Serbia
Query!
State/province [210]
0
0
Vojvodina
Query!
Country [211]
0
0
Singapore
Query!
State/province [211]
0
0
Singapore
Query!
Country [212]
0
0
Slovakia
Query!
State/province [212]
0
0
Banska Bystrica
Query!
Country [213]
0
0
Slovakia
Query!
State/province [213]
0
0
Nitra
Query!
Country [214]
0
0
Slovenia
Query!
State/province [214]
0
0
Ljubljana
Query!
Country [215]
0
0
South Africa
Query!
State/province [215]
0
0
Free State
Query!
Country [216]
0
0
South Africa
Query!
State/province [216]
0
0
Gauteng
Query!
Country [217]
0
0
South Africa
Query!
State/province [217]
0
0
Western Cape
Query!
Country [218]
0
0
Spain
Query!
State/province [218]
0
0
Cantabria
Query!
Country [219]
0
0
Spain
Query!
State/province [219]
0
0
Illes Balears
Query!
Country [220]
0
0
Spain
Query!
State/province [220]
0
0
Las Palmas
Query!
Country [221]
0
0
Spain
Query!
State/province [221]
0
0
Navarra
Query!
Country [222]
0
0
Spain
Query!
State/province [222]
0
0
A Coruna
Query!
Country [223]
0
0
Spain
Query!
State/province [223]
0
0
Barcelona
Query!
Country [224]
0
0
Spain
Query!
State/province [224]
0
0
Girona
Query!
Country [225]
0
0
Spain
Query!
State/province [225]
0
0
Huelva
Query!
Country [226]
0
0
Spain
Query!
State/province [226]
0
0
Madrid
Query!
Country [227]
0
0
Spain
Query!
State/province [227]
0
0
Sevilla
Query!
Country [228]
0
0
Spain
Query!
State/province [228]
0
0
Valencia
Query!
Country [229]
0
0
Sweden
Query!
State/province [229]
0
0
Hallands Lan
Query!
Country [230]
0
0
Sweden
Query!
State/province [230]
0
0
Vastra Gotalands Lan
Query!
Country [231]
0
0
Switzerland
Query!
State/province [231]
0
0
Zuerich
Query!
Country [232]
0
0
Switzerland
Query!
State/province [232]
0
0
Bern
Query!
Country [233]
0
0
Taiwan
Query!
State/province [233]
0
0
Taipei City
Query!
Country [234]
0
0
Taiwan
Query!
State/province [234]
0
0
Taoyuan City
Query!
Country [235]
0
0
Turkey
Query!
State/province [235]
0
0
Istanbul
Query!
Country [236]
0
0
Turkey
Query!
State/province [236]
0
0
Kayseri
Query!
Country [237]
0
0
Turkey
Query!
State/province [237]
0
0
Ankara
Query!
Country [238]
0
0
Turkey
Query!
State/province [238]
0
0
Battalgazi/malatya
Query!
Country [239]
0
0
Turkey
Query!
State/province [239]
0
0
Hatay
Query!
Country [240]
0
0
Turkey
Query!
State/province [240]
0
0
Mersin
Query!
Country [241]
0
0
Turkey
Query!
State/province [241]
0
0
Sisli
Query!
Country [242]
0
0
Turkey
Query!
State/province [242]
0
0
Yenimahalle
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
London, City Of
Query!
Country [246]
0
0
United Kingdom
Query!
State/province [246]
0
0
Bath
Query!
Country [247]
0
0
United Kingdom
Query!
State/province [247]
0
0
Birmingham
Query!
Country [248]
0
0
United Kingdom
Query!
State/province [248]
0
0
Dudley
Query!
Country [249]
0
0
United Kingdom
Query!
State/province [249]
0
0
Harrow
Query!
Country [250]
0
0
United Kingdom
Query!
State/province [250]
0
0
London
Query!
Country [251]
0
0
United Kingdom
Query!
State/province [251]
0
0
Newcastle Upon Tyne
Query!
Country [252]
0
0
United Kingdom
Query!
State/province [252]
0
0
Stockport
Query!
Country [253]
0
0
United Kingdom
Query!
State/province [253]
0
0
Taunton
Query!
Country [254]
0
0
United Kingdom
Query!
State/province [254]
0
0
Tooting
Query!
Country [255]
0
0
United Kingdom
Query!
State/province [255]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
AbbVie
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared
to placebo as induction therapy in participants with moderately and severely active Crohn's
disease (CD).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03345836
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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ABBVIE INC.
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AbbVie
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03345836
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