Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Crohn Disease Clinical Trial

— SEAVUE  

Official title:

A Phase 3b, Multicenter, Randomized, Blinded, Active-Controlled Study to Compare the Efficacy and Safety of Ustekinumab to That of Adalimumab in the Treatment of Biologic Naïve Subjects With Moderately-to-Severely Active Crohn's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464136
• Other study ID #: CR108449
• Secondary ID: 2017-004209-41CN
• Status: Completed
• Phase: Phase 3
• Start date: March 29, 2018
• Est. completion date: May 21, 2021

Study information

• Verified date: June 2023
• Source: Janssen Scientific Affairs, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of treatment with ustekinumab or adalimumab in biologic naive participants with moderately-to-severely active Crohn's disease (CD) who have previously failed or were intolerant to conventional therapy (corticosteroids and/or immunomodulators, such as azathioprine, 6-mercaptopurine, or methotrexate), as measured by clinical remission at one year.

Description:

This study compares the safety and efficacy of ustekinumab versus adalimumab. It will consist of screening (within 1- 5 weeks prior to Week 0), treatment phase (Weeks 0 to 52), and follow-up phase (up to Week 76). The primary hypothesis is that ustekinumab is superior to adalimumab as measured by clinical remission after one year of treatment. Study assessments will include Crohn's disease activity index (CDAI), video ileocolonoscopy; CD-related healthcare utilization; 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 randomly be assigned to receive either ustekinumab or adalimumab. No participants will be treated with placebo only.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: May 21, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Has Crohn's Disease (CD) or fistulizing CD of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy

• Has moderately-to-severely active CD with a baseline Crohn's disease activity index (CDAI) score of greater than or equal to (>=) 220 and less than or equal to (<=) 450

• Has one or more ulceration on screening ileocolonoscopy (which by definition, would result in an Simple Endoscopic Score for Crohn's Disease [SES-CD] of at least 3)

• Has failed or was intolerant to conventional therapy (corticosteroids, azathioprine [AZA], 6-mercaptopurine [6-MP] and/or methotrexate [MTX]) at adequate doses or is corticosteroid dependent

• Has not previously received an approved biologic for Crohn's Disease (i.e., infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)

• Participants on oral corticosteroids (e.g., prednisone, budesonide) at a prednisone-equivalent dose of <=40 or milligram/day (mg/day) or <=9 mg/day of budesonide are budesonide <=9 mg/day are permitted if doses are stable for 3 weeks prior to baseline

• Participants on AZA, 6-MP, or MTX at screening (or recently prior), must discontinue these medications at least 3 weeks prior to baseline

Exclusion Criteria:

• Has complications of CD that are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using the CDAI, such as: active stoma; short-gut syndrome and severe or symptomatic strictures or stenosis

• 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 prior to baseline, or 8 weeks prior for intra-abdominal abscesses, if 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 present

• Has had any kind of bowel resection within 6 months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within 3 months prior to baseline

• Has a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen

• Has received a Bacillus Calmette-Guerin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 2 weeks of baseline

• Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection (eg, recurrent pyelonephritis or chronic nonremitting cystitis), or infected skin wounds or ulcers

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Biological:
• Placebo for Ustekinumab
Participants will receive placebo as SC injection to blind adalimumab.
• Placebo for Adalimumab
Participants will receive placebo as IV infusion to blind ustekinumab.
• Ustekinumab (6 mg/kg)
Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
• Ustekinumab (90 mg)
Participants will self-administer SC injection of ustekinumab 90 mg.
• Adalimumab (40 mg)
Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

Locations

Country	Name	City	State
Australia	Monash Health, Monash Medical Centre	Clayton
Australia	Alfred Hospital	Melbourne
Australia	Mater Hospital Brisbane (Inflammatory Bowel Diseases)	South Brisbane
Australia	St John of God Subiaco Hospital	Subiaco
Australia	The Queen Elizabeth Hospital	Woodville South
Belgium	UZ Gent	Gent
Belgium	UZ Leuven	Leuven
Belgium	CHwapi	Tournai
Brazil	Hospital Das Clinicas Da Ufmg	Belo Horizonte - MG
Brazil	Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro	Goiania
Brazil	Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida	Juiz de Fora
Brazil	Hospital das Clinicas de Porto Alegre	Porto Alegre
Brazil	Hospital das Clínicas da Faculdade de Medicina de RPUSP - HCRP	Ribeirao Preto
Brazil	Hospital Copa D'Or	Rio de Janeiro
Brazil	Universidade Federal do Rio de Janeiro - Faculdade de Medicina	Rio de Janeiro
Brazil	Fundacao do ABC - Centro Universitario FMABC	Santo Andre
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	MHAT Rousse	Rousse
Bulgaria	2-nd MHAT	Sofia
Bulgaria	Diagnostic Consulting Center Mladost - M Varna	Varna
Canada	University of Calgary	Calgary	Alberta
Canada	CISSS de la Monteregie Centre	Greenfield Park	Quebec
Canada	McMaster University	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario
Canada	CMIIM, Centre médical L'Enjeu	Mont-Royal	Quebec
Czechia	Fakultní nemocnice u sv. Anny v Brn	Brno
Czechia	Nemocnice Horovice, a.s.	Horovice
Czechia	Hepato-gastroenterologie HK, s.r.o.	Hradec Kralove
Czechia	Fakultni nemocnice Kralovske Vinohrady	Praha 10
Czechia	ISCARE a.s.	Praha 9
France	CHU Amiens	Amiens
France	CHRU Montpellier - Hopital Saint-Eloi	Montpellier
France	Hotel Dieu	Nantes
France	Hopital Saint-Louis	Paris
France	CHU Saint-etienne	Saint Priest en jarez
France	Clinique Ambroise Pare	Toulouse
Germany	Universitatsklinikum Freiburg	Freiburg
Germany	Asklepios Westklinikum	Hamburg
Germany	Uniklinikum Heidelberg	Heidelberg
Germany	MVZ Portal10	Muenster
Hungary	Réthy Pál Kórház - Rendelointézet	Békéscsaba
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Semmelweis Egyetem	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz	Miskolc
Hungary	Markusovszky Egyetemi Oktatokorhaz	Szombathely
Italy	Policlinico Sant'Orsola Malpighi	Bologna
Italy	AOU Policlinico G.Martino	Messina
Italy	ASST Fatebenefratelli Sacco	Milano
Italy	Azienda Ospedaliera di Padova	Padova
Italy	Ospedale Villa Sofia-Cervello	Palermo
Italy	Azienda Ospedaliera G.Salvini Ospedale di Rho	RHO
Italy	Azienda Complesso Ospedaliero San Filippo Neri	Roma
Italy	Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'	Roma
Italy	Fondazione Policlinico Gemelli Università Cattolica	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	AO Ordine Mauriziano	Torino
Korea, Republic of	Yeungnam University Hospital	Daegu
Korea, Republic of	The Catholic university of Korea, St. Vincent's Hospital	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System	Seoul
Netherlands	VUMC Amsterdam	Amsterdam
Netherlands	Rijnstate Ziekenhuis	Arnhem
Netherlands	UMCG	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Radboudumc	Nijmegen
Netherlands	Ikazia Ziekenhuis	Rotterdam
Netherlands	Sint Franciscus Gasthuis	Rotterdam
Poland	Gastromed Kralisz Romatowski Stachurska Sp. j.	Bialystok
Poland	Synexus Polska Sp. z o.o.	Gdansk
Poland	Centrum Medyczne Plejady	Krakow
Poland	Centrum Medyczne Pratia Poznan	Krakow
Poland	Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego	Lodz
Poland	Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie, Oddzial Gastroenterologii	Lublin
Poland	Centrum Medyczne Medyk	Rzeszow
Poland	Endoskopia Sp. z o.o. z siedziba w Sopocie	Sopot
Poland	Centralny Szpital Kliniczny MSWiA w Warszawie	Warsaw
Poland	Gabinety Lekarskie Bodyclinic	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warszawa
Poland	Melita Medical Sp. z o.o.	Wroclaw
Poland	ETG Zamosc	Zamosc
Russian Federation	OOO MO New Hospital	Ekaterinburg
Russian Federation	Irkutsk State Medical Academy of Postgraduate Education	Irkutsk
Russian Federation	GU Moscow Regional Research Clinical Institute n.a. M.F.Vla	Moscva
Russian Federation	Rostov State Medical University	Rostov-On-Don
Russian Federation	City Clinical Hospital #31	Saint Petersburg
Russian Federation	Elizavetinskaya hospital	Saint Petersburg
Russian Federation	City Clinical Hospital # 21	Ufa
Russian Federation	GBUZ Respublican Clinical Hospital n.a. GG Kuvatova	Ufa
Serbia	Clinical Hospital Center Zemun	Belgrade
Serbia	Clinical Hospital Center Zvezdara	Belgrade
Serbia	University Clinical Center Kragujevac	Kragujevac
Serbia	University Clinical Center NIS	Nis
Serbia	Clinical Center of Vojvodina	Vojvodina
Serbia	Clinical Hospital Center Bezanijska Kosa	Zemun
Spain	Hosp. de La Santa Creu I Sant Pau	Barcelona
Spain	Hosp. Del Mar	Barcelona
Spain	Hosp. Univ. Dr. Josep Trueta	Girona
Spain	Hosp. Univ. Central de Asturias	Oviedo
Spain	Corporacio Sanitari Parc Tauli	Sabadell
Spain	Hosp. Clinico Univ. de Salamanca	Salamanca
Spain	Hosp. Univ. Marques de Valdecilla	Santander
Spain	Hosp. Virgen Macarena	Sevilla
Spain	Hosp. Univ. Rio Hortega	Valladolid
Spain	Hosp. Univ. Miguel Servet	Zaragoza
United Kingdom	Royal United Hospital	Bath
United Kingdom	Pennine Acute Hospitals-Fairfield General Hospital	Bury
United Kingdom	Kingston Hospital	Kingston upon Thames
United Kingdom	Guy's and St Thomas' Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	Southampton University Hospitals NHS Trust	Southampton
United Kingdom	Musgrove Park Hospital	Taunton
United States	Digestive Health Partners	Asheville	North Carolina
United States	Texas Digestive Disease Consultants	Baton Rouge	Louisiana
United States	Northshore Gastroenterology Research, LLC	Beachwood	Ohio
United States	Washington Gastroenterology, PLLC	Bellevue	Washington
United States	Gastro Associates of Fairfield County PC	Bridgeport	Connecticut
United States	Saratoga Schenectady Gastroenterology Associates	Burnt Hills	New York
United States	Aztec Clinical Research, Inc.	Channelview	Texas
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Gastroenterology Associates of Tidewater	Chesapeake	Virginia
United States	Clinical Research Institute of Michigan, LLC	Chesterfield	Michigan
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	TriHealth Digestive Institute	Cincinnati	Ohio
United States	Gastro Florida	Clearwater	Florida
United States	University Hospitals Case Medical Center	Cleveland	Ohio
United States	Peak Gastroenterology Associates	Colorado Springs	Colorado
United States	Ohio State University Hospital	Columbus	Ohio
United States	Tri-State Gastroenterology Assoc	Crestview Hills	Kentucky
United States	Western Connecticut Health Network/Danbury Hospital	Danbury	Connecticut
United States	Dayton Gastroenterology, Inc	Dayton	Ohio
United States	Verity Research, Inc	Fairfax	Virginia
United States	Fargo Gastroenterology Clinic, PC	Fargo	North Dakota
United States	Florida Research Network, LLC	Gainesville	Florida
United States	DHAT Research Institute	Garland	Texas
United States	NYU Langone Long Island Clinical Research Associates	Great Neck	New York
United States	Gastroenterology Associates P.A.	Greenville	South Carolina
United States	Gastroenterology Associates Of Hazard	Hazard	Kentucky
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	CroNOLA, LLC	Houma	Louisiana
United States	Baylor College of Medicine	Houston	Texas
United States	University of Texas at Houston Medical School	Houston	Texas
United States	Grand Teton Research Group, PLLC	Idaho Falls	Idaho
United States	Florida Center For Gastroenterology	Largo	Florida
United States	University of Louisville	Louisville	Kentucky
United States	Gastroenterology Associates of Central Virginia	Lynchburg	Virginia
United States	Center for Advanced Gastroenterology	Maitland	Florida
United States	Great Lakes Gastroenterology Research, LLC	Mentor	Ohio
United States	Alabama Medical Group	Mobile	Alabama
United States	Gastroenterology Group Of Naples	Naples	Florida
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Digestive And Liver Disease Specialists	Norfolk	Virginia
United States	Digestive Disease Specialists Inc	Oklahoma City	Oklahoma
United States	Allegheny-Singer Research Institute	Pittsburgh	Pennsylvania
United States	Advanced Medical Research Center	Port Orange	Florida
United States	Premier Medical Group Of The Hudson Valley, Pc	Poughkeepsie	New York
United States	Health Science Research Center	Pratt	Kansas
United States	Duke University Hospital Medical Center	Raleigh	North Carolina
United States	McGuire VAMC	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	Mercy Clinic East Community	Saint Louis	Missouri
United States	Saint Louis University Hospital	Saint Louis	Missouri
United States	Gastroenterology Research of America, LLC	San Antonio	Texas
United States	Precision Research Institute	San Diego	California
United States	Louisiana Research Center, LLC	Shreveport	Louisiana
United States	Texas Digestive Disease Consultants	Southlake	Texas
United States	Virginia Gastroenterology Institute	Suffolk	Virginia
United States	Atlanta Gastroenterology Specialists, PC	Suwanee	Georgia
United States	Washington Gastroenterology, PLLC	Tacoma	Washington
United States	Apex Clinical Research	Tampa	Florida
United States	Tyler Research Institute, LLC	Tyler	Texas
United States	Medstar Washington Hospital Center	Washington	District of Columbia
United States	Cleveland Clinic Florida	Weston	Florida
United States	Wilmington Gastroenterology Associates	Wilmington	North Carolina
United States	Huron Gastroenterology Associates Center for Digestive Care	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Scientific Affairs, LLC

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Czechia,  France,  Germany,  Hungary,  Italy,  Korea, Republic of,  Netherlands,  Poland,  Russian Federation,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Clinical Remission at Week 52	Percentage of participants with clinical remission at Week 52 were assessed. Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) score of less than (<) 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 52
Secondary	Percentage of Participants With Corticosteroid-free Remission at Week 52	Percentage of participants with Corticosteroid-free remission at Week 52 were assessed. Corticosteroid-free remission was defined as CDAI score <150 points at Week 52 and not taking any corticosteroids for at least 30 days prior to Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	Week 52
Secondary	Percentage of Participants With Clinical Response at Week 52	Percentage of participants with clinical response at Week 52 were assessed. Clinical response at Week 52 was defined as a reduction from baseline in the CDAI score of greater than or equal (>=) 100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	Week 52
Secondary	Percentage of Participants in Patient Reported Outcome (PRO)-2 Symptom Remission at Week 52	PRO2 evaluated 2 patient-reported symptoms: the frequency of liquid or soft stools (total number of soft/liquid stools in the last 7 days) and abdominal pain (on a 4-point scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe). A weekly score was calculated for the liquid or soft stool frequency and a separate weekly score was calculated for abdominal pain, in each case based on daily symptom reporting. PRO-2 symptom remission was defined as an abdominal pain (AP) mean daily score at or below 1 and also stool frequency (SF) mean daily score at or below 3, that is, AP <=1 and SF <=3. PRO2 is a composite index consisting of weighted scoring of both variables. PRO-2 scores range from 0 to no upper limit with higher scores indicating more severe disease.	Week 52
Secondary	Percentage of Participants With Clinical Remission at Week 16	Percentage of participants with clinical remission (defined as CDAI <150 points) at Week 16 were assessed. Clinical remission was defined as a CDAI score of < 150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.	Week 16
Secondary	Percentage of Participants With Endoscopic Remission at Week 52	Percentage of participants with endoscopic remission at Week 52 were assessed. Endoscopic remission was defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score less than or equal to (<=) 3, or SES-CD =0 for participants who entered the study with a SES-CD =3 at Week 52. The SES-CD evaluates 4 endoscopic variables (ulcer size, proportion of the surface area that is ulcerated, proportion of the surface area affected, and stenosis) each rated from 0 (best) to 3 (worst) in 5 segments evaluated during ileocolonoscopy (ileum, right colon, transverse colon, left colon, and rectum). The score for each endoscopic variable is the sum of values obtained for each segment. The SES-CD total is the sum of the 4 endoscopic variable scores from 0 to 56, where higher scores indicate more severe disease.	Week 52
Secondary	Percentage of Participants With Clinical Remission Through Week 52	Percentage of participants with clinical remission at each postbaseline visit through Week 52 were reported. Clinical remission was defined as a CDAI score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants With Clinical Response Through Week 52	Percentage of participants with clinical response at each postbaseline visit through Week 52 were reported. Clinical response through Week 52 was defined as a reduction from baseline in the CDAI score of >=100 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants With Durable Clinical Response at Week 52	Percentage of participants with durable clinical response at Week 52 were reported. Durable clinical response was defined as CDAI score decreased at least 100 from baseline or CDAI <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	Week 52
Secondary	Percentage of Participants With Durable Clinical Remission at Week 52	Percentage of participants with durable clinical remission at Week 52 were reported. Clinical remission was defined as CDAI score <150 at Week 52 and was >= 80% of all visits between Week 16 and Week 52. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	Week 52
Secondary	Percentage of Participants With Abdominal Pain (AP) Improvement Through Week 52	Percentage of participants with AP improvement through Week 52 were reported. AP improvement was defined as at least 1 point or greater improvement in mean daily CDAI AP score (ranges from 0 to 3 where higher score indicates severity of pain) from baseline, or a mean score of zero among participants with mean AP>0 at baseline, compared at each visit through Week 52.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants With Reduction in Frequency of Diarrhea Through Week 52	Number of participants with reduction in frequency of diarrhea were reported. Reduction in frequency of diarrhea was defined as a reduction of at least 3 (or a mean number <1) in SF (that is, mean daily number of liquid or very soft stools from CDAI score [ranges from 0 to 3 where higher score indicates severity of pain] in the week prior to the visit) from baseline, among subjects with mean SF >1 at baseline, compared at each visit through Week 52.	Weeks 2, 8, 16, 24, 32, 40, 48, and 52
Secondary	Percentage of Participants With Clinical and Biomarker Remission at Weeks 8, 16 and 52	Percentage of participants with clinical and biomarker remission was defined as the percentage of participants with CDAI <150, CRP <= 3 mg/L, and also fecal calprotectin <=250 micrograms per gram (mcg/g). The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. A decrease in CDAI over time indicates improvement in disease activity.	At Weeks 8, 16 and 52
Secondary	Percentage of Participants With Adverse Events (AEs)	Percentage of participants with AE were reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.	Up to Week 52 and up to Week 76
Secondary	Percentage of Participants With Infections	Percentage of participants with infections were reported.	Up to Week 52 and up to Week 76
Secondary	Percentage of Participants With Serious Infections	Percentage of participants with serious infections were reported.	Up to Week 52 and up to Week 76
Secondary	Percentage of Participants With Serious Adverse Events (SAEs)	Percentage of participants with SAEs were reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above. Coronavirus disease 2019 (COVID-19) related adverse events are adverse events with any of the following preferred terms "COVID-19", "Asymptomatic COVID-19", "Suspected COVID-19", "COVID-19 pneumonia", "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test positive" or with a reported term containing the string "COVI.	Up to Week 52 and up to Week 76
Secondary	Percentage of Participants With Anti-drug Antibodies	Percentage of participants with anti-drug antibodies were reported. Serum samples were assessed for anti-drug antibodies. Anti-drug assays were performed for ustekinumab and adalimumab.	Up to Week 52