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A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease (POWER)

Primary Purpose

Crohn Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ustekinumab approximately 6 mg/kg (IV)
Placebo (SC)
Placebo (IV)
Ustekinumab 90 mg (SC) Group 1
Ustekinumab 90 mg (SC) Group 2
Sponsored by
Janssen-Cilag Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  • A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy
  • Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and <=450 with at least one of the following: Elevated C-reactive protein (CRP) (>3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin (fCal) >250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or equal to (<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon)
  • Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral corticosteroids (for example {e.g.}, prednisone, budesonide) at a prednisone-equivalent dose of <=40 mg/day or <=9 mg/day of budesonide, antibiotics used as the primary treatment of Crohn's disease, or conventional immunomodulators (i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are permitted providing the doses indicated are stable before baseline or have been discontinued before baseline within the protocol defined durations

Exclusion Criteria:

  • Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
  • Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
  • Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline
  • A draining (i.e., functioning) stoma or ostomy
  • Received ustekinumab intravenous re-induction after the initial weight-tiered-based IV induction dose of ustekinumab
  • Any known history of shortened frequency of SC dose administration (<q8w) for a secondary loss of response where the participant did not, in the opinion of the treating physician, benefit from the dose interval shortening

Sites / Locations

  • University of California, San Diego
  • Peak Gastroenterology Associates
  • Florida Research Network, LLC
  • Mayo Clinic Jacksonville
  • Advent Health
  • Florida Hospital Tampa
  • Emory University
  • Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's
  • Atlanta Gastroenterology Specialists
  • University of Kentucky Chandler Medical Center
  • Chevy Chase Clinical Research
  • Brigham & Women's Hospital
  • University of Mississippi Medical Center
  • Washington University School of Medicine
  • Mount Sinai School of Medicine
  • Ohio State University Hospital
  • Northshore Gastroenterology Research, LLC
  • Oklahoma Digestive Disease Specialists
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Texas Digestive Disease Consultants
  • Baylor College of Medicine
  • Houston Methodist Hospital
  • Gastroenterology Research of America, LLC
  • Tyler Research Institute, LLC
  • Virginia Mason Medical Center
  • University of Washington
  • Washington Gastroenterology, PLLC
  • Krankenhaus der Barmherzigen Brüder
  • Medizinische Universität Wien
  • Hepato-gastroenterologie HK, s.r.o.
  • ISCARE a.s.
  • Hopital Beaujon
  • CHRU de Lille - Hopital Claude Huriez
  • CHRU Montpellier - Hopital Saint-Eloi
  • CHU Hopital Saint Antoine
  • Hospices Civils de Lyon HCL
  • CHRU Hopital de Pontchaillou
  • CHU de Nancy_ Hopital Brabois
  • Klinikum Augsburg
  • GASTRO-Studien
  • Charite - Universitatsmedizin Berlin (CCM)
  • Medizinisches Versorgungszentrum (MVZ) Dachau
  • University Hospital Dresden
  • Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
  • Universitatsklinikum Frankfurt/ Medizinische Klinik 1
  • Universitatsklinikum Freiburg
  • Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
  • Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
  • Gastroenterologie Opernstrasse
  • Universitatsklinikum Schleswig-Holstein - Kiel
  • Staedtisches Klinikum Lueneburg
  • Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
  • Medizinische Fakultät Mannheim der Universität Heidelberg
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Klinikum der Universitaet Muenchen
  • Praxis Dr. med. Ulf Helwig
  • Zentrum für Gastroenterologie Saar MVZ GmbH
  • Universitaetsklinik Tuebingen
  • Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  • Ospedale Villa Sofia-Cervello
  • Azienda Ospedaliera G.Salvini Ospedale di Rho
  • Fondazione Policlinico Gemelli Università Cattolica
  • Istituto Clinico Humanitas
  • AO Ordine Mauriziano
  • Inje University Haeundae Paik Hospital
  • Seoul National University Hospital
  • Severance Hospital, Yonsei University Health System
  • Asan Medical Center
  • KyungHee University Hospital
  • Onze Lieve Vrouwe Gasthuis
  • Leiden University Medical Center
  • Maastricht Universitair Medisch Centrum
  • Radboudumc
  • Erasmus MC
  • Sint Franciscus Gasthuis
  • Irkutsk State Medical Academy of Postgraduate Education
  • Olla-Med, Llc
  • City Clinical Hospital #31
  • GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
  • Hosp. Univ. Fundacion Alcorcon
  • Hosp. Arquitecto Marcide
  • Hosp. Gral. Univ. Gregorio Maranon
  • Hosp. Univ. La Paz
  • Hosp. Univ. Virgen de La Arrixaca
  • Hosp. Virgen de La Victoria
  • Hosp. de Navarra
  • Hosp. Montecelo
  • Corporacio Sanitari Parc Tauli
  • Hosp. Clinico Univ. de Salamanca
  • Hosp. Univ. Marques de Valdecilla
  • Hosp. Clinico Univ. de Valencia
  • Hosp. Alvaro Cunqueiro
  • Hosp. Clinico Univ. Lozano Blesa
  • Hosp. Univ. Miguel Servet
  • Gastromottagningen
  • Gastromottagningen
  • Pennine Acute Hospitals-Fairfield General Hospital
  • Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
  • Royal Devon & Exeter Hospital
  • King's College Hospital NHS Foundation Trust
  • St George's Hospital
  • Southampton University Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group 1: Ustekinumab (IV re-induction)

Group 2: Ustekinumab (Continuous q8w SC maintenance)

Arm Description

Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.

Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Response at Week 16
Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.

Secondary Outcome Measures

Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24
Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Percentage of Participants With Clinical Response at Weeks 8 and 24
Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24
Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Percentage of Participants With Treatment-emergent Infections
Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Percentage of Participants With Treatment-emergent Serious Infections
Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.

Full Information

First Posted
December 11, 2018
Last Updated
August 16, 2023
Sponsor
Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03782376
Brief Title
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease
Acronym
POWER
Official Title
A Phase 3b, Randomized, Double-blind, Multicenter Study to Evaluate the Safety and Efficacy of Intravenous Re-induction Therapy With Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
August 19, 2022 (Actual)
Study Completion Date
January 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the efficacy and safety of a single intravenous (IV) re-induction dose of approximately 6 milligram per kilogram (mg/kg) ustekinumab in participants with secondary loss of response (LoR) to subcutaneous (SC) every 8 Weeks (q8w) 90 mg ustekinumab maintenance therapy.
Detailed Description
This study compares the efficacy and safety of a single weight-tiered based IV re-induction dose of approximately 6 mg/kg ustekinumab versus continuing with regular SC q8w 90 mg ustekinumab administration. It consists of screening (5 weeks); treatment period (Week 0 to 24); and safety follow up visit (20 weeks after last dose). The primary hypothesis is that a single IV re-induction dose of ustekinumab is superior to continuing with regular SC q8w maintenance treatment as measured by clinical response after 16 weeks of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy, patient-reported outcomes (PROs), laboratory evaluations, biomarkers, review of concomitant medications and adverse events (AEs), and evaluation of serum concentrations of study agent as well as development of antibodies to study agent. All participants will be randomly assigned to receive either ustekinumab IV re-induction or regular SC q8w 90 mg ustekinumab injection at baseline in a double dummy design. No participants will be treated with placebo only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1: Ustekinumab (IV re-induction)
Arm Type
Experimental
Arm Description
Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Arm Title
Group 2: Ustekinumab (Continuous q8w SC maintenance)
Arm Type
Active Comparator
Arm Description
Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab approximately 6 mg/kg (IV)
Other Intervention Name(s)
STELARA
Intervention Description
Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Intervention Type
Drug
Intervention Name(s)
Placebo (SC)
Intervention Description
Participants will receive SC injection of placebo at Week 0.
Intervention Type
Drug
Intervention Name(s)
Placebo (IV)
Intervention Description
Participants will receive IV infusion of placebo at Week 0.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg (SC) Group 1
Other Intervention Name(s)
STELARA
Intervention Description
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab 90 mg (SC) Group 2
Other Intervention Name(s)
STELARA
Intervention Description
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response at Week 16
Description
Clinical response was defined as greater than or equal to (>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score < 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at Weeks 8, 16, and 24
Description
Percentage of participants with clinical remission at Weeks 8, 16, and 24 were reported. Clinical remission was defined as CDAI score of <150 points. CDAI is a validated multi-item measure of severity of illness derived as weighted sum of 8 different CD-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical remission, regardless of their CDAI score.
Time Frame
Weeks 8, 16, and 24
Title
Percentage of Participants With Clinical Response at Weeks 8 and 24
Description
Clinical response was defined as a >=100-point reduction from the baseline in CDAI score or a CDAI score <150 point. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by the participant on a diary card. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
Time Frame
Weeks 8 and 24
Title
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Weeks 16 and 24
Description
Percentage of participants with normalization at Weeks 16 and 24, among participants with elevated CRP and/or fCal at baseline were reported. Participants were considered to be normalized if at least one biomarker (fCal or CRP) was normalized. Normalized CRP=CRP value less than or equal to (<=) 3 milligrams per liter(mg/L). Normalized fCal concentrations was defined as <=250 micrograms per gram(mcg/g). When either CRP or FCal value was abnormal at baseline and value of same parameter normalizes at designated analysis timepoint, participants were considered to be normalized at designated analysis timepoint. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes, or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint are considered not to be normalized. Participants who had insufficient data at designated analysis timepoint had their last value carried forward.
Time Frame
Weeks 16 and 24
Title
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description
An adverse event was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An adverse event does not necessarily have a causal relationship with the treatment. TEAEs were adverse events with onset during the intervention phase or that were a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent. In this outcome measure, TEAEs including all AEs irrespective of being serious or non-serious AE are reported.
Time Frame
From baseline (Week 0) up to Week 36
Title
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Description
A serious adverse event (SAE) was an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; a suspected transmission of any infectious agent via a medicinal product; medically important. TESAEs were adverse events with onset during the intervention phase or that are a consequence of a pre-existing condition that had worsened since baseline. Any AE occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time Frame
From baseline (Week 0) up to Week 36
Title
Percentage of Participants With Treatment-emergent Infections
Description
Percentage of participants with treatment-emergent infections were reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time Frame
From baseline (Week 0) up to Week 36
Title
Percentage of Participants With Treatment-emergent Serious Infections
Description
Percentage of participants with treatment-emergent serious infections was reported. Any infection occurring at or after the initial administration of study agent through the end of the trial was considered to be treatment emergent.
Time Frame
From baseline (Week 0) up to Week 36
Title
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
Description
Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
Time Frame
Baseline, Weeks 8, 16, 24
Title
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
Description
Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
Time Frame
Baseline, Weeks 8, 16, 24
Title
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
Description
Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
Time Frame
Baseline, Weeks 8, 16, 24
Title
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Description
Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
Time Frame
Baseline, Weeks 8, 16, 24
Title
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
Description
Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
Time Frame
Baseline, Weeks 8, 16, 24
Title
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Description
Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.
Time Frame
Baseline, Weeks 8, 16, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekinumab maintenance therapy and initially responded to ustekinumab induction therapy, administered according to the local label, followed by secondary loss of response (LoR) to ustekinumab. Secondary LoR to ustekinumab is defined as active disease at study baseline, proven by a Crohn's Disease Activity Index (CDAI) score of greater than or equal to (>=) 220 and <=450 with at least one of the following: Elevated C-reactive protein (CRP) (>3.0 milligram per liter [mg/L]); and/or elevated Fecal calprotectin (fCal) >250 milligram per kilogram [mg/kg]); and/or endoscopy (performed less than or equal to (<=) 3 months before baseline) with evidence of active Crohn's disease, (defined as one or more ulcerations in the ileum and/or colon) Participants receiving either oral 5-aminosalicylic acid (5-ASA) compounds, oral corticosteroids (for example {e.g.}, prednisone, budesonide) at a prednisone-equivalent dose of <=40 mg/day or <=9 mg/day of budesonide, antibiotics used as the primary treatment of Crohn's disease, or conventional immunomodulators (i.e., azathioprine [AZA], 6-mercaptopurine [6-MP], or methotrexate [MTX]) are permitted providing the doses indicated are stable before baseline or have been discontinued before baseline within the protocol defined durations Exclusion Criteria: Complications of Crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks before baseline (or 8 weeks before baseline for intra-abdominal abscesses) provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified Any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months before baseline A draining (i.e., functioning) stoma or ostomy Received ustekinumab intravenous re-induction after the initial weight-tiered-based IV induction dose of ustekinumab Any known history of shortened frequency of SC dose administration (<q8w) for a secondary loss of response where the participant did not, in the opinion of the treating physician, benefit from the dose interval shortening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag Ltd. Clinical Trial
Organizational Affiliation
Janssen-Cilag Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Peak Gastroenterology Associates
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Florida Research Network, LLC
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Mayo Clinic Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Advent Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Florida Hospital Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342-5020
Country
United States
Facility Name
Atlanta Gastroenterology Specialists
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ohio State University Hospital
City
Hilliard
State/Province
Ohio
ZIP/Postal Code
43026
Country
United States
Facility Name
Northshore Gastroenterology Research, LLC
City
Westlake
State/Province
Ohio
ZIP/Postal Code
44145
Country
United States
Facility Name
Oklahoma Digestive Disease Specialists
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Cedar Park
State/Province
Texas
ZIP/Postal Code
78613
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Houston Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2740
Country
United States
Facility Name
Gastroenterology Research of America, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Tyler Research Institute, LLC
City
Tyler
State/Province
Texas
ZIP/Postal Code
75701
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Washington Gastroenterology, PLLC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Wien
ZIP/Postal Code
1020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hepato-gastroenterologie HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
ISCARE a.s.
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Hopital Beaujon
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHRU de Lille - Hopital Claude Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHRU Montpellier - Hopital Saint-Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hopital Saint Antoine
City
Paris cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Hospices Civils de Lyon HCL
City
Pierre Bénite
ZIP/Postal Code
69495
Country
France
Facility Name
CHRU Hopital de Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Nancy_ Hopital Brabois
City
Vandoeuvre-les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
D-86158
Country
Germany
Facility Name
GASTRO-Studien
City
Berlin
ZIP/Postal Code
10825
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin (CCM)
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Medizinisches Versorgungszentrum (MVZ) Dachau
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
University Hospital Dresden
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
City
Frankfurt
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitatsklinikum Frankfurt/ Medizinische Klinik 1
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
City
Hamburg
ZIP/Postal Code
20251
Country
Germany
Facility Name
Gastroenterologie Opernstrasse
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein - Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Staedtisches Klinikum Lueneburg
City
Lueneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Medizinische Fakultät Mannheim der Universität Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Praxis Dr. med. Ulf Helwig
City
Oldenburg
ZIP/Postal Code
26123
Country
Germany
Facility Name
Zentrum für Gastroenterologie Saar MVZ GmbH
City
Saarbrücken
ZIP/Postal Code
66111
Country
Germany
Facility Name
Universitaetsklinik Tuebingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Ospedale Villa Sofia-Cervello
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Azienda Ospedaliera G.Salvini Ospedale di Rho
City
RHO
Country
Italy
Facility Name
Fondazione Policlinico Gemelli Università Cattolica
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
AO Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Inje University Haeundae Paik Hospital
City
Busan
ZIP/Postal Code
48108
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
KyungHee University Hospital
City
Seoul
ZIP/Postal Code
102-1703
Country
Korea, Republic of
Facility Name
Onze Lieve Vrouwe Gasthuis
City
Amsterdam
ZIP/Postal Code
1091 AC
Country
Netherlands
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Maastricht Universitair Medisch Centrum
City
Maastricht
ZIP/Postal Code
6229 HX
Country
Netherlands
Facility Name
Radboudumc
City
Nijmegen
ZIP/Postal Code
6525 GA
Country
Netherlands
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Name
Sint Franciscus Gasthuis
City
Rotterdam
ZIP/Postal Code
3045 PM
Country
Netherlands
Facility Name
Irkutsk State Medical Academy of Postgraduate Education
City
Irkutsk
ZIP/Postal Code
664079
Country
Russian Federation
Facility Name
Olla-Med, Llc
City
Moscow
ZIP/Postal Code
105554
Country
Russian Federation
Facility Name
City Clinical Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
City
Ufa
ZIP/Postal Code
450005
Country
Russian Federation
Facility Name
Hosp. Univ. Fundacion Alcorcon
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Facility Name
Hosp. Arquitecto Marcide
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hosp. Gral. Univ. Gregorio Maranon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp. Univ. La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp. Univ. Virgen de La Arrixaca
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hosp. Virgen de La Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hosp. de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hosp. Montecelo
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Corporacio Sanitari Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hosp. Clinico Univ. de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hosp. Univ. Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hosp. Clinico Univ. de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hosp. Alvaro Cunqueiro
City
Vigo
ZIP/Postal Code
36213
Country
Spain
Facility Name
Hosp. Clinico Univ. Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Hosp. Univ. Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Gastromottagningen
City
Malmö
ZIP/Postal Code
20502
Country
Sweden
Facility Name
Gastromottagningen
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
Facility Name
Pennine Acute Hospitals-Fairfield General Hospital
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Facility Name
Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Royal Devon & Exeter Hospital
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
St George's Hospital
City
London
ZIP/Postal Code
SW17 OQT
Country
United Kingdom
Facility Name
Southampton University Hospitals NHS Trust
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials\transparency. As noted on this site, requests for access to the study data can be submitted through Yale open and Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency
Citations:
PubMed Identifier
34334713
Citation
Ten Bokkel Huinink S, Biemans V, Duijvestein M, Pierik M, Hoentjen F, West RL, van der Woude CJ, de Vries AC. Re-induction with intravenous Ustekinumab after secondary loss of response is a valid optimization strategy in Crohn's disease. Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e783-e788. doi: 10.1097/MEG.0000000000002256.
Results Reference
derived

Learn more about this trial

A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

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