- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03782376
A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease (POWER)
February 20, 2024 updated by: Janssen-Cilag Ltd.
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
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
215
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Wien, Austria, 1090
- Medizinische Universität Wien
-
Wien, Austria, 1020
- Krankenhaus der Barmherzigen Brüder
-
-
-
-
-
Hradec Kralove, Czechia, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
-
Praha 9, Czechia, 190 00
- ISCARE a.s.
-
-
-
-
-
Clichy, France, 92110
- Hopital Beaujon
-
Lille, France, 59037
- CHRU de Lille - Hopital Claude Huriez
-
Montpellier, France, 34295
- CHRU Montpellier - Hopital Saint-Eloi
-
Paris cedex 12, France, 75571
- CHU Hopital Saint Antoine
-
Pierre Bénite, France, 69495
- Hospices Civils de Lyon HCL
-
Rennes, France, 35033
- CHRU Hopital de Pontchaillou
-
Vandoeuvre-les-Nancy, France, 54511
- CHU de Nancy_ Hopital Brabois
-
-
-
-
-
Augsburg, Germany, D-86158
- Klinikum Augsburg
-
Berlin, Germany, 10825
- GASTRO-Studien
-
Berlin, Germany, 12203
- Charite - Universitaetsmedizin Berlin (CCM)
-
Dachau, Germany, 85221
- Medizinisches Versorgungszentrum (MVZ) Dachau
-
Dresden, Germany, 1307
- University Hospital Dresden
-
Frankfurt, Germany, 60431
- Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
-
Frankfurt, Germany, 60590
- Universitatsklinikum Frankfurt/ Medizinische Klinik 1
-
Freiburg, Germany, 79106
- Universitätsklinikum Freiburg
-
Halle, Germany, 06120
- Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH
-
Hamburg, Germany, 20251
- Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K.
-
Kassel, Germany, 34117
- Gastroenterologie Opernstrasse
-
Kiel, Germany, 24105
- Universitatsklinikum Schleswig Holstein Kiel
-
Lueneburg, Germany, 21339
- Staedtisches Klinikum Lueneburg
-
Magdeburg, Germany, 39120
- Universitätsklinikum Otto-von-Guericke-Universität Magdeburg
-
Mannheim, Germany, 68167
- Medizinische Fakultat Mannheim der Universitat Heidelberg
-
Minden, Germany, 32423
- Gastroenterologische Gemeinschaftspraxis Minden
-
Muenchen, Germany, 81377
- Klinikum der Universitaet Muenchen
-
Oldenburg, Germany, 26123
- Praxis Dr. med. Ulf Helwig
-
Saarbrücken, Germany, 66111
- Zentrum für Gastroenterologie Saar MVZ GmbH
-
Tübingen, Germany, 72076
- Universitaetsklinik Tuebingen
-
Ulm, Germany, 89081
- Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II
-
-
-
-
-
Milano, Italy, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
-
Palermo, Italy, 90146
- Ospedale Villa Sofia-Cervello
-
RHO, Italy
- Azienda Ospedaliera G.Salvini Ospedale di Rho
-
Roma, Italy, 168
- Fondazione Policlinico Gemelli Università Cattolica
-
Rozzano, Italy, 20089
- Istituto Clinico Humanitas
-
Torino, Italy, 10128
- AO Ordine Mauriziano
-
-
-
-
-
Busan, Korea, Republic of, 48108
- Inje University Haeundae Paik Hospital
-
Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
-
Seoul, Korea, Republic of, 03722
- Severance Hospital, Yonsei University Health System
-
Seoul, Korea, Republic of, 05505
- Asan Medical Center
-
Seoul, Korea, Republic of, 102-1703
- KyungHee University Hospital
-
-
-
-
-
Amsterdam, Netherlands, 1091 AC
- Onze Lieve Vrouwe Gasthuis
-
Leiden, Netherlands, 2333 ZA
- Leiden University Medical Center
-
Maastricht, Netherlands, 6229 HX
- Maastricht Universitair Medisch Centrum
-
Nijmegen, Netherlands, 6525 GA
- Radboudumc
-
Rotterdam, Netherlands, 3015 GD
- Erasmus MC
-
Rotterdam, Netherlands, 3045 PM
- Sint Franciscus Gasthuis
-
-
-
-
-
Irkutsk, Russian Federation, 664079
- Irkutsk State Medical Academy of Postgraduate Education
-
Moscow, Russian Federation, 105554
- Olla-Med, Llc
-
St. Petersburg, Russian Federation, 197110
- City Clinical Hospital #31
-
Ufa, Russian Federation, 450005
- GBUZ Respublican Clinical Hospital n.a. GG Kuvatova
-
-
-
-
-
Alcorcón, Spain, 28922
- Hosp. Univ. Fundacion Alcorcon
-
Ferrol, Spain, 15405
- Hosp. Arquitecto Marcide
-
Madrid, Spain, 28046
- Hosp. Univ. La Paz
-
Madrid, Spain, 28007
- Hosp. Gral. Univ. Gregorio Maranon
-
Murcia, Spain, 30120
- Hosp. Univ. Virgen de La Arrixaca
-
Málaga, Spain, 29010
- Hosp. Virgen de La Victoria
-
Pamplona, Spain, 31008
- Hosp. de Navarra
-
Pontevedra, Spain, 36071
- Hosp. Montecelo
-
Sabadell, Spain, 08208
- Corporacio Sanitari Parc Tauli
-
Salamanca, Spain, 37007
- Hosp. Clinico Univ. de Salamanca
-
Santander, Spain, 39008
- Hosp. Univ. Marques de Valdecilla
-
Valencia, Spain, 46010
- Hosp. Clinico Univ. de Valencia
-
Vigo, Spain, 36213
- Hosp. Alvaro Cunqueiro
-
Zaragoza, Spain, 50009
- Hosp. Clinico Univ. Lozano Blesa
-
Zaragoza, Spain, 50009
- Hosp. Univ. Miguel Servet
-
-
-
-
-
Malmö, Sweden, 20502
- Gastromottagningen
-
Stockholm, Sweden, 18288
- Gastromottagningen
-
-
-
-
-
Bury, United Kingdom, BL9 7TD
- Pennine Acute Hospitals-Fairfield General Hospital
-
Cheltenham, United Kingdom, GL53 7AN
- Gloucestershire Hospitals NHS Foundation Trust - Cheltenham
-
Exeter, United Kingdom, EX2 5DW
- Royal Devon & Exeter Hospital
-
London, United Kingdom, SE5 9RS
- King's College Hospital NHS Foundation Trust
-
London, United Kingdom, SW17 OQT
- St George's Hospital
-
Southampton, United Kingdom, SO16 6YD
- Southampton University Hospitals NHS Trust
-
-
-
-
California
-
La Jolla, California, United States, 92093
- University of California, San Diego
-
-
Colorado
-
Colorado Springs, Colorado, United States, 80907
- Peak Gastroenterology Associates
-
-
Florida
-
Gainesville, Florida, United States, 32605
- Florida Research Network, LLC
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic Jacksonville
-
Orlando, Florida, United States, 32803
- Advent Health
-
Tampa, Florida, United States, 33613
- Florida Hospital Tampa
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Emory University
-
Atlanta, Georgia, United States, 30342-5020
- Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's
-
Suwanee, Georgia, United States, 30024
- Atlanta Gastroenterology Specialists
-
-
Kentucky
-
Lexington, Kentucky, United States, 40536
- University of Kentucky Chandler Medical Center
-
-
Maryland
-
Chevy Chase, Maryland, United States, 20815
- Chevy Chase Clinical Research
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Brigham & Women's Hospital
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- University of Mississippi Medical Center
-
-
Missouri
-
Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
New York
-
New York, New York, United States, 10029
- Mount Sinai School of Medicine
-
-
Ohio
-
Hilliard, Ohio, United States, 43026
- Ohio State University Hospital
-
Westlake, Ohio, United States, 44145
- Northshore Gastroenterology Research, LLC
-
-
Oklahoma
-
Oklahoma City, Oklahoma, United States, 73112
- Oklahoma Digestive Disease Specialists
-
-
South Carolina
-
Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
-
-
Tennessee
-
Nashville, Tennessee, United States, 37212
- Vanderbilt University Medical Center
-
-
Texas
-
Cedar Park, Texas, United States, 78613
- Texas Digestive Disease Consultants
-
Houston, Texas, United States, 77025
- Baylor College of Medicine
-
Houston, Texas, United States, 77030-2740
- Houston Methodist Hospital
-
San Antonio, Texas, United States, 78229
- Gastroenterology Research of America, LLC
-
Tyler, Texas, United States, 75701
- Tyler Research Institute, LLC
-
-
Washington
-
Seattle, Washington, United States, 98195
- University of Washington
-
Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
-
Tacoma, Washington, United States, 98405
- Washington Gastroenterology, PLLC
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Ustekinumab (IV re-induction)
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 will receive ustekinumab approximately 6mg/kg intravenously at Week 0.
Other Names:
Participants will receive SC injection of placebo at Week 0.
Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.
Other Names:
|
Active Comparator: Group 2: Ustekinumab (Continuous q8w SC maintenance)
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.
|
Participants will receive IV infusion of placebo at Week 0.
Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Clinical Response at Week 16
Time Frame: 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.
|
Week 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: From baseline (Week 0) up to Week 36
|
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.
|
From baseline (Week 0) up to Week 36
|
Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs)
Time Frame: From baseline (Week 0) up to Week 36
|
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.
|
From baseline (Week 0) up to Week 36
|
Percentage of Participants With Treatment-emergent Infections
Time Frame: From baseline (Week 0) up to Week 36
|
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.
|
From baseline (Week 0) up to Week 36
|
Percentage of Participants With Treatment-emergent Serious Infections
Time Frame: From baseline (Week 0) up to Week 36
|
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.
|
From baseline (Week 0) up to Week 36
|
Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein)
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
|
Baseline, Weeks 8, 16, 24
|
Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit)
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
|
Baseline, Weeks 8, 16, 24
|
Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets)
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
|
Baseline, Weeks 8, 16, 24
|
Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST])
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
|
Baseline, Weeks 8, 16, 24
|
Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine)
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
|
Baseline, Weeks 8, 16, 24
|
Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate)
Time Frame: Baseline, Weeks 8, 16, 24
|
Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.
|
Baseline, Weeks 8, 16, 24
|
Percentage of Participants With Clinical Remission at Week 16
Time Frame: Week 16
|
Percentage of participants with clinical remission at Week 16 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.
|
Week 16
|
Percentage of Participants With Clinical Response at Week 8
Time Frame: Week 8
|
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 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 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.
|
Week 8
|
Percentage of Participants With Clinical Remission at Week 8
Time Frame: Week 8
|
Percentage of participants with clinical remission at Week 8 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.
|
Week 8
|
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16
Time Frame: Week 16
|
Percentage of participants with normalization at Week 16, 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.
|
Week 16
|
Percentage of Participants With Clinical Remission at Week 24
Time Frame: Week 24
|
Percentage of participants with clinical remission at Week 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.
|
Week 24
|
Percentage of Participants With Clinical Response at Week 24
Time Frame: Week 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.
|
Week 24
|
Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24
Time Frame: Week 24
|
Percentage of participants with normalization at Week 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.
|
Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Janssen-Cilag Ltd. Clinical Trial, Janssen-Cilag Ltd.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 20, 2018
Primary Completion (Actual)
August 19, 2022
Study Completion (Actual)
January 10, 2023
Study Registration Dates
First Submitted
December 11, 2018
First Submitted That Met QC Criteria
December 19, 2018
First Posted (Actual)
December 20, 2018
Study Record Updates
Last Update Posted (Actual)
February 22, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR108533
- 2018-002629-51 (EudraCT Number)
- CNTO1275CRD3008 (Other Identifier: Janssen-Cilag Ltd.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD 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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Crohn Disease
-
ProgenaBiomeRecruitingCrohn Disease | Crohn Colitis | Crohn's Ileocolitis | Crohn's Gastritis | Crohn's Jejunitis | Crohn's Duodenitis | Crohn's Esophagitis | Crohn's | Crohn Disease of Ileum | Crohn Ileitis | Crohn's Disease Relapse | Crohns Disease Aggravated | Crohn Disease in Remission | Crohn's Disease of PylorusUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
Chinese University of Hong KongTerminatedCrohn Disease | Perianal Crohn DiseaseHong Kong
-
SandozCompletedCrohn´s DiseaseAustria, Germany, Poland, Spain, Sweden
-
Dr. Falk Pharma GmbHCompleted
-
University of Erlangen-Nürnberg Medical SchoolCompleted
-
Groupe Hospitalier Paris Saint JosephCompleted
-
Ferring PharmaceuticalsTerminatedCrohn´s DiseaseUnited Kingdom, United States, Germany, Belgium, Denmark, France, Sweden
-
Jinling Hospital, ChinaCompletedCrohn Disease in RemissionChina
-
Boehringer IngelheimTerminatedFibrostenotic Crohn´s DiseaseUnited States, Canada, Japan, Sweden
Clinical Trials on Ustekinumab approximately 6 mg/kg (IV)
-
Janssen Research & Development, LLCTerminatedLupus Erythematosus, SystemicUnited States, Japan, Korea, Republic of, Canada, Taiwan, Thailand, Germany, China, Serbia, Spain, Portugal, Russian Federation, Poland, Ukraine, Lithuania, South Africa, Hungary, Argentina, Bulgaria, Colombia
-
Janssen Research & Development, LLCWithdrawnLupus Erythematosus, SystemicChina
-
Janssen Research & Development, LLCCompletedCrohn's Disease | Colitis | Inflammatory Bowel Disease | IBDUnited States, France, Poland, United Kingdom, Germany, Spain, Israel, Bulgaria, Serbia, South Africa, Japan, Australia, Canada, Netherlands, Korea, Republic of, New Zealand, Brazil, Russian Federation, Belgium, Hungary, Croatia, ...
-
Janssen Pharmaceutical K.K.Terminated
-
Janssen Research & Development, LLCCompletedCrohn's Disease | Colitis | Inflammatory Bowel Disease | IBDUnited States, France, Poland, United Kingdom, Germany, Spain, Serbia, South Africa, Japan, Israel, Canada, Australia, Netherlands, Korea, Republic of, Belgium, New Zealand, Brazil, Austria, Ireland, Czech Republic, Hungary, Denmark, Icela...
-
Centocor, Inc.CompletedCrohn's DiseaseUnited States, France, United Kingdom, Germany, Spain, Belgium, Israel, Australia, Canada, Netherlands, New Zealand, Austria
-
BioMarin PharmaceuticalTerminatedDuchenne Muscular DystrophyBelgium, Netherlands, Italy, Sweden
-
BioMarin PharmaceuticalTerminatedDuchenne Muscular DystrophyNetherlands, Belgium, Italy, Sweden
-
Centocor, Inc.CompletedCrohn DiseaseUnited States, Canada, Belgium
-
Janssen Research & Development, LLCCompletedPsoriasisUnited States, Germany, Taiwan, Belgium, Korea, Republic of, Canada, Poland, Hungary, Netherlands