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

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year



Sponsors


Source

Janssen Scientific Affairs, LLC

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


Brief 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.

Detailed 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.

Overall Status

Recruiting

Start Date

2018-03-29

Completion Date

2020-12-01

Primary Completion Date

2020-04-30

Phase

Phase 3

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Percentage of Participants with Clinical Remission at Week 52
Week 52

Secondary Outcome

Measure

Time Frame

Percentage of Participants with Corticosteroid-free Remission at Week 52 (Major Secondary Endpoint)
Week 52
Percentage of Participants with Clinical Response at Week 52 (Major Secondary Endpoint)
Week 52
Percentage of Participants with Endoscopic Remission at Week 52 (Major Secondary Endpoint)
Week 52
Percentage of Participants with Clinical Remission at Week 16 (Major Secondary Endpoint)
Week 16
Percentage of Participants with Clinical Response through Week 52
up to Week 52
Percentage of Participants with Clinical Remission (beginning at Week 8) through Week 52
up to Week 52
Change from Baseline in CDAI score through Week 52
Baseline, up to Week 52
Change from Baseline in the Sum of Number of stools and Abdominal Pain Scores of CDAI [without weighting] through Week 52 (PRO-2)
Baseline, up to Week 52
Change from Baseline in Weighted Sum of Abdominal pain and Stool Frequency subscores of CDAI through Week 52 (PRO-2 Weighted)
Baseline, up to Week 52
Percentage of Participants with Endoscopic Response at Week 52
Week 52
Percentage of Participants with Endoscopic Improvement at Week 52
Week 52
Change from Baseline in SES-CD Score at Week 52
Week 52
Percentage of Participants with minimum of 25% Improvement from Baseline in SES-CD Score at Week 52
Week 52
Percentage of Participants with Fistula Resolution through Week 52
up to Week 52
Percentage of Participants with Fistula Response through Week 52
up to Week 52
Percentage of Participants with Corticosteroid-free Response at Week 52
Week 52
Percentage of Participants with Corticosteroid-free Remission at Week 52 [among participants who were on corticosteroids at baseline]
Week 52
Percentage of Participants with Corticosteroid-free Response at Week 52 [among participants who were on corticosteroids at baseline]
Week 52
Number of Visits of Participants in Steroid-free Remission through Week 52
up to Week 52
Change from Baseline in CRP concentration through Week 52
Baseline, up to Week 52
Percentage of Participants with Normalization of CRP through Week 52
up to Week 52
Change from Baseline in Fecal Calprotectin Concentration through Week 52
Baseline, up to Week 52
Percentage of Participants with Fecal calprotectin <= 250 microgram/gram (mcg/g) through Week 52
up to Week 52
Percentage of Participants with Fecal calprotectin < 100 mcg/g through Week 52
up to Week 52
Percentage of Participants with Clinical Remission and >=50% Reduction in Baseline CRP or Fecal calprotectin through Week 52
up to Week 52
Percentage of Participants with Clinical Remission and >=50% Reduction in Baseline CRP or Fecal calprotectin through Week 52 [among Participants with Elevated CRP or Fecal calprotectin >250 mcg/g at Baseline]
up to Week 52
Percentage of Participants with Clinical Remission, CRP <= 3 mg/L and Fecal calprotectin <=250 mcg/g through Week 52
up to Week 52
Percentage of Participants with Clinical Remission, CRP <= 3 mg/L and Fecal calprotectin <=250 mcg/g through Week 52 [among Participants with Elevated CRP (>3 mg/L) or Fecal calprotectin >250 mcg/g at Baseline]
up to Week 52
Percentage of Participants with Clinical Biomarker Response through Week 52
up to Week 52
Percentage of Participants with Clinical Biomarker Response through Week 52 [among Participants with Elevated CRP (>3 mg/L) or Fecal calprotectin >250 mcg/g at Baseline]
up to Week 52
Percentage of Participants with Clinical Response, CRP <=3 mg/L, and Fecal calprotectin <=250 mcg/g through Week 52
up to Week 52
Percentage of Participants with Clinical Response, CRP <=3 mg/L, and Fecal calprotectin <=250 mcg/g through Week 52 [among Participants with Elevated CRP (>3 mg/L) or Fecal calprotectin >250 mcg/g at Baseline]
up to Week 52
Percentage of Participants with Durable Clinical Remission at Week 52
Week 52
Time to First flare [among Participants in Clinical Response]
up to Week 52, and Week 56
Percentage of Participants with Adverse Events (AEs)
up to Week 52, and Week 76
Percentage of Participants with Infections
up to Week 52 and Week 76
Percentage of Participants with Serious Adverse Events (SAEs)
up to Week 52, and Week 76
Percentage of Participants with Serious Infections
up to Week 52, and Week 76
Percentage of Participants with Anti-drug Antibodies through Week 52
up to Week 52
Percentage of Participants on Concomitant Narcotic Pain Medications for Crohn's Disease (CD)
up to Week 52
Percentage of Participants able to Eliminate Concomitant Narcotic Pain Medication Use for CD
up to Week 52
Percentage of Participants on Concomitant Narcotic Pain Medications for any Reason
up to Week 52
Percentage of Participants able to Eliminate Concomitant Narcotic Pain Medication Use for any Reason
up to Week 52
Total Number of Days Participants are off to Concomitant Narcotic Pain Medications
up to Week 52
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) score at Weeks 8, 16 and 52
Baseline, Week 8, 16 and 52
Percentage of Participants with IBDQ Response
Week 8, 16 and 52
Percentage of Participants with IBDQ Remission
Week 8, 16 and 52
Change from Baseline in Domain scores of Patient Reported Outcome Measurement Information System questionnaires (PROMIS-29) at Week 8, 16 and 52
Baseline, Week 8, 16 and 52
Percentage of Participants with T-score decrease of >= 5 in each of PROMIS-29 Questionnaire Domains
Week 8, 16 and 52
Change from Baseline in Combined Score (Pain Score from PROMIS-29 and Number of Liquid or Soft stools) at Week 8, 16 and 52
Baseline, Week 8, 16 and 52
Change from Baseline in Work Productivity and Activity Index (WPAI) Questionnaire at Week 8, 16 and 52
Baseline, Week 8, 16 and 52
Percentage of Participants with CD-related Hospitalization, Surgeries, or Initiation of Non-study Alternate Biologic for CD
Week 52 and Week 76
Percentage of Participants with CD-related Hospitalization or Surgeries
Week 52 and Week 76
Percentage of Participants initiating a Non-study Alternate Biologic for CD
Week 52 and Week 76
Percentage of Participants with CD-related Hospitalization
Week 52 and Week 76
Percentage of Participants with CD-related Surgeries
Week 52 and Week 76
Percentage of Participants with a CD-related Emergency Room (ER) Visit
Week 52
Total Number of Days for Participants with CD-related Hospitalization
up to Week 52
Percentage of Participants with Endoscopic Procedure related to CD
up to Week 52
Percentage of Participants with Clinical Response at Week 56
Week 56
Percentage of Participants with Clinical Remission at Week 56
Week 56
Change from Baseline in CDAI Score at Week 56
Baseline and Week 56
Percentage of Participants with Normalization of CRP at Week 56
Week 56
Total Time in Steroid-free Remission
up to Week 56

Enrollment

350

Condition


Intervention

Intervention Type

Biological

Intervention Name


Description

Participants will receive placebo as SC injection to blind adalimumab.

Arm Group Label

Group 1 (Ustekinumab)


Intervention Type

Biological

Intervention Name


Description

Participants will receive placebo as IV infusion to blind ustekinumab.

Arm Group Label

Group 2 (Adalimumab)


Intervention Type

Biological

Intervention Name


Description

Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.

Arm Group Label

Group 1 (Ustekinumab)

Other Name

Stelara


Intervention Type

Biological

Intervention Name


Description

Participants will self-administer SC injection of ustekinumab 90 mg.

Arm Group Label

Group 1 (Ustekinumab)

Other Name

Stelara


Intervention Type

Biological

Intervention Name


Description

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.

Arm Group Label

Group 2 (Adalimumab)

Other Name

Humira



Eligibility

Criteria

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 will result in an Simple
Endoscopic Score for Crohn's Disease (SES-CD) total score 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: 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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

No


Overall Official

Last Name

Role

Affiliation

Janssen Scientific Affairs, LLC Clinical Trial
Study Director
Janssen Scientific Affairs, LLC

Overall Contact

Last Name

Study Contact

Phone

844-434-4210

Email



Location

Facility

Status

UC San Diego
La Jolla California 92037 United States
Not yet recruiting
Precision Research Institute
San Diego California 92114 United States
Not yet recruiting
Peak Gastroenterology Associates
Colorado Springs Colorado 80907 United States
Not yet recruiting
Gastro Associates of Fairfield County PC
Bridgeport Connecticut 06606 United States
Recruiting
Gastro Florida
Clearwater Florida 33756 United States
Recruiting
Center for Advanced Gastroenterology - Main Office
Maitland Florida 32751 United States
Not yet recruiting
Gastroenterology Group Of Naples
Naples Florida 34102 United States
Not yet recruiting
Advanced Medical Research Center
Port Orange Florida 32127 United States
Recruiting
Apex Clinical Research
Tampa Florida 33612 United States
Not yet recruiting
Cleveland Clinic Florida
Weston Florida 33331 United States
Not yet recruiting
Emory University
Atlanta Georgia 30322 United States
Not yet recruiting
Atlanta Gastroenterology Associates
Atlanta Georgia 30342 United States
Not yet recruiting
Atlanta Gastroenterology Specialists, PC
Suwanee Georgia 30024 United States
Not yet recruiting
Northwestern University
Chicago Illinois 60611 United States
Not yet recruiting
Health Science Research Center
Pratt Kansas 67124 United States
Not yet recruiting
Tri-State Gastroenterology Assoc
Crestview Hills Kentucky 41017 United States
Not yet recruiting
Gastroenterology Associates Of Hazard
Hazard Kentucky 41701 United States
Not yet recruiting
University of Louisville
Louisville Kentucky 40202 United States
Not yet recruiting
CroNOLA, LLC
Houma Louisiana 70360 United States
Not yet recruiting
Louisiana Research Center, LLC
Shreveport Louisiana 71105 United States
Not yet recruiting
Chevy Chase Clinical Research
Chevy Chase Maryland 20815 United States
Not yet recruiting
Clinical Research Institute of Michigan, LLC
Chesterfield Michigan 48047 United States
Recruiting
Huron Gastroenterology Associates Center for Digestive Care
Ypsilanti Michigan 48197 United States
Not yet recruiting
Mayo Clinic
Rochester Minnesota 55905 United States
Not yet recruiting
Saratoga Schenectady Gastroenterology Associates
Burnt Hills New York 12027 United States
Not yet recruiting
NYU Langone Long Island Clinical Research Associates
Great Neck New York 11021 United States
Not yet recruiting
Columbia University
New York New York 10028 United States
Not yet recruiting
Mount Sinai School of Medicine
New York New York 10029 United States
Not yet recruiting
University of Rochester Medical Center
Rochester New York 14642 United States
Not yet recruiting
University of North Carolina at Chapel Hill
Chapel Hill North Carolina 27599 United States
Recruiting
Duke University Hospital Medical Center
Raleigh North Carolina 27609 United States
Not yet recruiting
Wilmington Gastroenterology Associates
Wilmington North Carolina 28403 United States
Recruiting
University Hospitals Case Medical Center
Cleveland Ohio 44106 United States
Not yet recruiting
Great Lakes Gastroenterology Research, LLC
Mentor Ohio 44060 United States
Recruiting
Digestive Disease Specialists Inc
Oklahoma City Oklahoma 73112 United States
Not yet recruiting
Penn State Milton S. Hershey Medical Center
Hershey Pennsylvania 17036 United States
Not yet recruiting
Vanderbilt University Medical Center
Nashville Tennessee 37212 United States
Not yet recruiting
Baylor College of Medicine
Houston Texas 77025 United States
Not yet recruiting
University of Texas at Houston Medical School
Houston Texas 77030 United States
Not yet recruiting
DHAT Research Institute
Richardson Texas 75082 United States
Not yet recruiting
Gastroenterology Research of America, LLC
San Antonio Texas 78229 United States
Not yet recruiting
Texas Digestive Disease Consultants
Southlake Texas 76092 United States
Not yet recruiting
Gastroenterology Associates of Tidewater
Chesapeake Virginia 23320 United States
Not yet recruiting
Grand Teton Research Group, PLLC
Fairfax Virginia 22031 United States
Not yet recruiting
Verity Research, Inc
Fairfax Virginia 22031 United States
Not yet recruiting
Digestive And Liver Disease Specialists
Norfolk Virginia 23502 United States
Not yet recruiting
McGuire VAMC
Richmond Virginia 23229 United States
Not yet recruiting
Virginia Gastroenterology Institute
Suffolk Virginia 23434 United States
Not yet recruiting
University of Washington
Seattle Washington 98195 United States
Not yet recruiting
Cliniques Universitaires Saint-Luc
Brussel 1200 Belgium
Not yet recruiting
UZ Gent
Gent 9000 Belgium
Not yet recruiting
UZ Leuven
Leuven 3000 Belgium
Not yet recruiting
CHwapi
Tournai 7500 Belgium
Not yet recruiting
UMHAT 'Dr. Georgi Stranski', EAD
Pleven 5800 Bulgaria
Not yet recruiting
MHAT Rousse
Rousse 7002 Bulgaria
Not yet recruiting
2-nd MHAT
Sofia 1202 Bulgaria
Not yet recruiting
Diagnostic Consulting Center Mladost - M Varna
Varna 9020 Bulgaria
Not yet recruiting
University of Calgary
Calgary Alberta T2N 4Z6 Canada
Not yet recruiting
University of Alberta - Department of Medicine
Edmonton Alberta T6G 2X8 Canada
Not yet recruiting
McMaster University
Hamilton Ontario L8S 4K1 Canada
Not yet recruiting
London Health Sciences Centre
London Ontario N6A 5A5 Canada
Not yet recruiting
CMIIM, Centre médical L'Enjeu
Mont-Royal Quebec H3P 3E5 Canada
Not yet recruiting
CHU Amiens-Hopital Nord
Amiens 80054 France
Not yet recruiting
CHRU Montpellier - Hopital Saint-Eloi
Montpellier 34295 France
Not yet recruiting
Hotel Dieu
Nantes 44035 France
Not yet recruiting
Hopital Saint-Louis
Paris 75010 France
Not yet recruiting
CHU Saint-etienne
Saint Priest En Jarez 42270 France
Not yet recruiting
Clinique Ambroise Paré
Toulouse 31082 France
Not yet recruiting
DRK Kliniken Westend
Berlin 14050 Germany
Not yet recruiting
Universitatsklinikum Freiburg
Freiburg 79106 Germany
Not yet recruiting
Asklepios Westklinikum
Hamburg 22559 Germany
Not yet recruiting
MVZ Portal10
Muenster 48151 Germany
Not yet recruiting
Klinik für Innere Medizin II
München 81675 Germany
Not yet recruiting
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest 1134 Hungary
Not yet recruiting
Semmelweis Egyetem
Budapest H-1088 Hungary
Not yet recruiting
Réthy Pál Kórház - Rendelőintézet
Békéscsaba H-5600 Hungary
Not yet recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen H-4032 Hungary
Not yet recruiting
Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz
Miskolc 3526 Hungary
Not yet recruiting
Markusovszky Egyetemi Oktatokorhaz
Szombathely H-9700 Hungary
Not yet recruiting
Csolnoky Ferenc Korhaz
Veszprém 8200 Hungary
Not yet recruiting
Policlinico Sant'Orsola Malpighi
Bologna 40138 Italy
Not yet recruiting
AOU Policlinico G.Martino
Messina 98125 Italy
Not yet recruiting
ASST Fatebenefratelli Sacco
Milano 20157 Italy
Not yet recruiting
Azienda Ospedaliera di Padova
Padova 35128 Italy
Not yet recruiting
Ospedale Villa Sofia-Cervello
Palermo 90146 Italy
Not yet recruiting
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho Italy
Not yet recruiting
Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata'
Roma 00133 Italy
Not yet recruiting
Azienda Complesso Ospedaliero San Filippo Neri
Roma 00135 Italy
Not yet recruiting
Fondazione Policlinico Gemelli Università Cattolica
Roma 168 Italy
Not yet recruiting
Istituto Clinico Humanitas
Rozzano 20089 Italy
Not yet recruiting
AO Ordine Mauriziano
Torino 10128 Italy
Not yet recruiting
VUMC Amsterdam
Amsterdam 1081 HV Netherlands
Not yet recruiting
UMCG
Groningen 9713 GZ Netherlands
Not yet recruiting
Leiden University Medical Center
Leiden 2333 ZA Netherlands
Not yet recruiting
Radboudumc
Nijmegen 6525 GA Netherlands
Not yet recruiting
Sint Franciscus Gasthuis
Rotterdam 3045 PM Netherlands
Not yet recruiting
Ikazia Ziekenhuis
Rotterdam 3083 AN Netherlands
Not yet recruiting
NZOZ Specjalistyczne Centrum Centrum Gastologii Gastromed
Bialystok 15-351 Poland
Not yet recruiting
Synexus Polska Sp. z o.o.
Gdańsk 80-382 Poland
Not yet recruiting
Malopolskie Centrum Medyczne
Krakow 30-510 Poland
Not yet recruiting
Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego
Lodz 90-153 Poland
Not yet recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
Lublin 20-954 Poland
Not yet recruiting
Endoskopia Sp z o.o.
Sopot 81-756 Poland
Not yet recruiting
Centralny Szpital Kliniczny Mswia
Warsaw 02-507 Poland
Not yet recruiting
NZOZ Vivamed Zespol Lekarzy Specjalistow
Warszawa 03 580 Poland
Not yet recruiting
Melita Medical
Wroclaw 50-449 Poland
Not yet recruiting
Hosp. Del Mar
Barcelona 08003 Spain
Not yet recruiting
Hosp. de La Santa Creu I Sant Pau
Barcelona 08041 Spain
Not yet recruiting
Hosp. Univ. Dr. Josep Trueta
Girona 17007 Spain
Not yet recruiting
Hosp. Univ. Central de Asturias
Oviedo 33011 Spain
Not yet recruiting
Corporacio Sanitari Parc Tauli
Sabadell 08208 Spain
Not yet recruiting
Hosp. Clinico Univ. de Salamanca
Salamanca 37007 Spain
Not yet recruiting
Hosp. Univ. Marques de Valdecilla
Santander 39008 Spain
Not yet recruiting
Hosp. Virgen Macarena
Sevilla 41009 Spain
Not yet recruiting
Hosp. Univ. Rio Hortega
Valladolid 47012 Spain
Not yet recruiting
Hosp. Univ. Miguel Servet
Zaragoza 50009 Spain
Not yet recruiting
Royal United Hospital
Bath BA1 3NG United Kingdom
Not yet recruiting
Royal Sussex County Hospital
Brighton BN2 5BE United Kingdom
Withdrawn
Bristol Royal Infirmary
Bristol BS2 8HW United Kingdom
Withdrawn
Pennine Acute Hospitals-Fairfield General Hospital
Bury BL9 7TD United Kingdom
Not yet recruiting
Kingston Hospital
Kingston Upon Thames KT2 7QB United Kingdom
Not yet recruiting
University College London Hospitals NHSFT
London NW1 2PG United Kingdom
Withdrawn
Guy's and St Thomas' Hospital
London SE1 7EH United Kingdom
Not yet recruiting
St George's Hospital
London SW17 0QT United Kingdom
Not yet recruiting
Royal Victoria Infirmary
Newcastle Upon Tyne NE1 4LP United Kingdom
Withdrawn
Derriford Hospital
Plymouth PL6 8DH United Kingdom
Withdrawn
Southampton University Hospitals NHS Trust
Southampton SO16 6YD United Kingdom
Not yet recruiting
Musgrove Park Hospital
Taunton TA1 5DA United Kingdom
Not yet recruiting

Location Countries

Country

Belgium

Bulgaria

Canada

France

Germany

Hungary

Italy

Netherlands

Poland

Spain

United Kingdom

United States



Verification Date

2018-06-01

Lastchanged Date

2018-04-18

Firstreceived Date

2018-03-07

Responsible Party

Responsible Party Type

Sponsor


Has Expanded Access

No

Condition Browse


Secondary Id

2017-004209-41

CNTO1275CRD3007


Number Of Arms

2

Intervention Browse

Mesh Term

Adalimumab

Ustekinumab



Arm Group

Arm Group Label

Group 1 (Ustekinumab)

Arm Group Type

Experimental

Description

Participants will receive intravenous (IV) infusion of ustekinumab (approximately 6 milligram/kilogram [mg/kg]) and 4 subcutaneous (SC) injections of placebo for adalimumab at Week 0, followed by 2 SC injections of placebo at Week 2. From Week 4 to Week 56, participants will self-administer one SC injection of ustekinumab 90 milligram (mg) every 8 weeks (q8w) starting at Week 8 and placebo adalimumab at the other designated every 2 weeks (q2w) dosing intervals.


Arm Group Label

Group 2 (Adalimumab)

Arm Group Type

Active Comparator

Description

Participants will receive IV infusion of placebo for ustekinumab and 4 SC injections of adalimumab (each 40 mg, total dose 160 mg) at Week 0, followed by 2 SC injections of adalimumab (each 40 mg, total dose 80 mg) at Week 2. From Week 4 to Week 56, participants will self-administer 1 SC injection of adalimumab 40 mg q2w.



Firstreceived Results Date

N/A

Acronym

SEAVUE

Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)


Study First Submitted

March 7, 2018

Study First Submitted Qc

March 7, 2018

Study First Posted

March 13, 2018

Last Update Submitted

June 13, 2018

Last Update Submitted Qc

June 13, 2018

Last Update Posted

June 14, 2018


ClinicalTrials.gov processed this data on June 14, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP