Study 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.

Condition or Disease	Intervention/Treatment
Crohn Disease	Drug: Ustekinumab approximately 6 mg/kg (IV) Drug: Placebo (SC) Drug: Placebo (IV) Drug: Ustekinumab 90 mg (SC) Group 1 Drug: Ustekinumab 90 mg (SC) Group 2

Study Design

Study Type	Interventional
Actual Enrollment	215 participants
Design Allocation	Randomized
Interventional Model	Parallel Assignment
Masking	Quadruple
Primary Purpose	Treatment
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 Start Date	December 20, 2018
Actual Primary Completion Date	August 19, 2022
Actual Study Completion Date	January 10, 2023

Groups and Cohorts

Group/ Cohort	Intervention/ Treatment
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.	Drug: Ustekinumab approximately 6 mg/kg (IV) Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0. Drug: Placebo (SC) Drug: Ustekinumab 90 mg (SC) Group 1
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.	Drug: Placebo (IV) Drug: Ustekinumab 90 mg (SC) Group 2

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants With Clinical Response at Week 16 [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

1. Percentage of Participants With Clinical Remission at Week 16 [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.
2. Percentage of Participants With Clinical Response at Week 8 [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.
3. Percentage of Participants With Clinical Remission at Week 8 [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.
4. Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 16 [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.
5. Percentage of Participants With Clinical Remission at Week 24 [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.
6. Percentage of Participants With Clinical Response at Week 24 [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.
7. Percentage of Participants With Normalization of C-reactive Protein (CRP) and/or Normalization of Fecal Calprotectin (fCal) Concentration at Week 24 [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.
8. Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) [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.
9. Percentage of Participants With Treatment-emergent Serious Adverse Events (TESAEs) [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.
10. Percentage of Participants With Treatment-emergent Infections [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.
11. Percentage of Participants With Treatment-emergent Serious Infections [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.
12. Change From Baseline in Clinical Laboratory Values for Hematology (Hemoglobin) and Chemistry (Albumin, Total Protein) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for hematology (hemoglobin) and chemistry (albumin, total protein) was reported.
13. Change From Baseline in Clinical Laboratory Values for Hematology (Hematocrit) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for hematology (hematocrit) was reported.
14. Change From Baseline in Clinical Laboratory Values for Hematology (Total White Blood Cell [WBC], Neutrophils, Absolute Lymphocyte, Eosinophils, Platelets) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for hematology (total WBC, neutrophils, absolute lymphocyte, eosinophils, platelets) was reported.
15. Change From Baseline in Clinical Laboratory Values for Chemistry (Alkaline Phosphatase, Alanine Transaminase [ALT], Aspartate Transaminase [AST]) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for chemistry (alkaline, ALT, AST) was reported.
16. Change From Baseline in Clinical Laboratory Values for Chemistry (Total Bilirubin, Direct Bilirubin, Creatinine) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for chemistry (total bilirubin, direct bilirubin, creatinine) was reported.
17. Change From Baseline in Clinical Laboratory Values for Chemistry (Sodium, Potassium, Chloride, Blood Urea Nitrogen [BUN]/Urea, Calcium, Phosphate) [Baseline, Weeks 8, 16, 24]
    Change from baseline in clinical laboratory values for chemistry (sodium, potassium, chloride, BUN/urea, calcium, phosphate) was reported.

Eligibility Criteria

Ages Eligible for Study	18 Years and Older (Adult, Older Adult)
Sexes Eligible for Study	All
Accepts Healthy Volunteers	No
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 (

Contacts and Locations

Sponsors and Collaborators	Janssen-Cilag Ltd.
Locations	University of California, San Diego | La Jolla, California, United States, 92093 Peak Gastroenterology Associates | Colorado Springs, Colorado, United States, 80907 Florida Research Network, LLC | Gainesville, Florida, United States, 32605 Mayo Clinic Jacksonville | Jacksonville, Florida, United States, 32224 Advent Health | Orlando, Florida, United States, 32803 Florida Hospital Tampa | Tampa, Florida, United States, 33613 Emory University | Atlanta, Georgia, United States, 30322 Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's | Atlanta, Georgia, United States, 30342-5020 Atlanta Gastroenterology Specialists | Suwanee, Georgia, United States, 30024 University of Kentucky Chandler Medical Center | Lexington, Kentucky, United States, 40536 Chevy Chase Clinical Research | Chevy Chase, Maryland, United States, 20815 Brigham & Women's Hospital | Boston, Massachusetts, United States, 02115 University of Mississippi Medical Center | Jackson, Mississippi, United States, 39202 Washington University School of Medicine | Saint Louis, Missouri, United States, 63110 Mount Sinai School of Medicine | New York, New York, United States, 10029 Ohio State University Hospital | Hilliard, Ohio, United States, 43026 Northshore Gastroenterology Research, LLC | Westlake, Ohio, United States, 44145 Oklahoma Digestive Disease Specialists | Oklahoma City, Oklahoma, United States, 73112 Medical University of South Carolina | Charleston, South Carolina, United States, 29425 Vanderbilt University Medical Center | Nashville, Tennessee, United States, 37212 Texas Digestive Disease Consultants | Cedar Park, Texas, United States, 78613 Baylor College of Medicine | Houston, Texas, United States, 77025 Houston Methodist Hospital | Houston, Texas, United States, 77030-2740 Gastroenterology Research of America, LLC | San Antonio, Texas, United States, 78229 Tyler Research Institute, LLC | Tyler, Texas, United States, 75701 Virginia Mason Medical Center | Seattle, Washington, United States, 98101 University of Washington | Seattle, Washington, United States, 98195 Washington Gastroenterology, PLLC | Tacoma, Washington, United States, 98405 Krankenhaus der Barmherzigen Brüder | Wien, Austria, 1020 Medizinische Universität Wien | Wien, Austria, 1090 Hepato-gastroenterologie HK, s.r.o. | Hradec Kralove, Czechia, 500 12 ISCARE a.s. | Praha 9, Czechia, 190 00 Hopital Beaujon | Clichy, France, 92110 CHRU de Lille - Hopital Claude Huriez | Lille, France, 59037 CHRU Montpellier - Hopital Saint-Eloi | Montpellier, France, 34295 CHU Hopital Saint Antoine | Paris cedex 12, France, 75571 Hospices Civils de Lyon HCL | Pierre Bénite, France, 69495 CHRU Hopital de Pontchaillou | Rennes, France, 35033 CHU de Nancy_ Hopital Brabois | Vandoeuvre-les-Nancy, France, 54511 Klinikum Augsburg | Augsburg, Germany, D-86158 GASTRO-Studien | Berlin, Germany, 10825 Charite - Universitaetsmedizin Berlin (CCM) | Berlin, Germany, 12203 Medizinisches Versorgungszentrum (MVZ) Dachau | Dachau, Germany, 85221 University Hospital Dresden | Dresden, Germany, 1307 Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus | Frankfurt, Germany, 60431 Universitatsklinikum Frankfurt/ Medizinische Klinik 1 | Frankfurt, Germany, 60590 Universitatsklinikum Freiburg | Freiburg, Germany, 79106 Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH | Halle, Germany, 06120 Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K. | Hamburg, Germany, 20251 Gastroenterologie Opernstrasse | Kassel, Germany, 34117 Universitatsklinikum Schleswig Holstein Kiel | Kiel, Germany, 24105 Staedtisches Klinikum Lueneburg | Lueneburg, Germany, 21339 Universitätsklinikum Otto-von-Guericke-Universität Magdeburg | Magdeburg, Germany, 39120 Medizinische Fakultät Mannheim der Universität Heidelberg | Mannheim, Germany, 68167 Gastroenterologische Gemeinschaftspraxis Minden | Minden, Germany, 32423 Klinikum der Universitaet Muenchen | Muenchen, Germany, 81377 Praxis Dr. med. Ulf Helwig | Oldenburg, Germany, 26123 Zentrum für Gastroenterologie Saar MVZ GmbH | Saarbrücken, Germany, 66111 Universitaetsklinik Tuebingen | Tübingen, Germany, 72076 Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II | Ulm, Germany, 89081 Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico | Milano, Italy, 20122 Ospedale Villa Sofia-Cervello | Palermo, Italy, 90146 Azienda Ospedaliera G.Salvini Ospedale di Rho | RHO, Italy, Fondazione Policlinico Gemelli Università Cattolica | Roma, Italy, 168 Istituto Clinico Humanitas | Rozzano, Italy, 20089 AO Ordine Mauriziano | Torino, Italy, 10128 Inje University Haeundae Paik Hospital | Busan, Korea, Republic of, 48108 Seoul National University Hospital | Seoul, Korea, Republic of, 03080 Severance Hospital, Yonsei University Health System | Seoul, Korea, Republic of, 03722 Asan Medical Center | Seoul, Korea, Republic of, 05505 KyungHee University Hospital | Seoul, Korea, Republic of, 102-1703 Onze Lieve Vrouwe Gasthuis | Amsterdam, Netherlands, 1091 AC Leiden University Medical Center | Leiden, Netherlands, 2333 ZA Maastricht Universitair Medisch Centrum | Maastricht, Netherlands, 6229 HX Radboudumc | Nijmegen, Netherlands, 6525 GA Erasmus MC | Rotterdam, Netherlands, 3015 GD Sint Franciscus Gasthuis | Rotterdam, Netherlands, 3045 PM Irkutsk State Medical Academy of Postgraduate Education | Irkutsk, Russian Federation, 664079 Olla-Med, Llc | Moscow, Russian Federation, 105554 City Clinical Hospital #31 | St. Petersburg, Russian Federation, 197110 GBUZ Respublican Clinical Hospital n.a. GG Kuvatova | Ufa, Russian Federation, 450005 Hosp. Univ. Fundacion Alcorcon | Alcorcón, Spain, 28922 Hosp. Arquitecto Marcide | Ferrol, Spain, 15405 Hosp. Gral. Univ. Gregorio Maranon | Madrid, Spain, 28007 Hosp. Univ. La Paz | Madrid, Spain, 28046 Hosp. Univ. Virgen de La Arrixaca | Murcia, Spain, 30120 Hosp. Virgen de La Victoria | Málaga, Spain, 29010 Hosp. de Navarra | Pamplona, Spain, 31008 Hosp. Montecelo | Pontevedra, Spain, 36071 Corporacio Sanitari Parc Tauli | Sabadell, Spain, 08208 Hosp. Clinico Univ. de Salamanca | Salamanca, Spain, 37007 Hosp. Univ. Marques de Valdecilla | Santander, Spain, 39008 Hosp. Clinico Univ. de Valencia | Valencia, Spain, 46010 Hosp. Alvaro Cunqueiro | Vigo, Spain, 36213 Hosp. Clinico Univ. Lozano Blesa | Zaragoza, Spain, 50009 Hosp. Univ. Miguel Servet | Zaragoza, Spain, 50009 Gastromottagningen | Malmö, Sweden, 20502 Gastromottagningen | Stockholm, Sweden, 18288 Pennine Acute Hospitals-Fairfield General Hospital | Bury, United Kingdom, BL9 7TD Gloucestershire Hospitals NHS Foundation Trust - Cheltenham | Cheltenham, United Kingdom, GL53 7AN Royal Devon & Exeter Hospital | Exeter, United Kingdom, EX2 5DW King's College Hospital NHS Foundation Trust | London, United Kingdom, SE5 9RS St George's Hospital | London, United Kingdom, SW17 OQT Southampton University Hospitals NHS Trust | Southampton, United Kingdom, SO16 6YD
Investigators

Study Documents (Full Text)

• Documents Provided by Janssen-Cilag Ltd.: Study Protocol August 5, 2020
• Documents Provided by Janssen-Cilag Ltd.: Statistical Analysis Plan October 17, 2022

More Information

Publications

• 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.

Additional Relevant MeSH Terms

• Crohn Disease
• Inflammatory Bowel Diseases
• Gastroenteritis
• Gastrointestinal Diseases
• Digestive System Diseases
• Intestinal Diseases