A Study to Compare the Efficacy and Safety of Ustekinumab With Adalimumab in the Treatment of Subjects With Moderately-to-Severely Active Crohn’s Disease, not Undergone Treatment With Biologic
- Conditions
- Crohn’s DiseaseMedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2017-004209-41-IT
- Lead Sponsor
- JANSSEN CILAG INTERNATIONAL NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 386
1.Be male or female and=18 years
2.HasCDor fistulizingCDof at least3months duration, with colitis, ileitis, or ileocolitis, confirmed at some time in the past by radiography, histology, and/or endoscopy
3.Has moderately-to-severely activeCDwith a baseline Crohn’s disease activity index(CDAI)score of=220and=450
4.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 least3
5.Meets the following requirements for prior or current medications for CD:
a)Has failed conventional therapy
i) Is currently receiving corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP) at adequate therapeutic doses; OR
ii)Has a history of failure to respond to, or tolerate, an adequate course of corticosteroids and/or immunomodulators (ie, AZA, MTX, or 6-MP); OR
iii) Is corticosteroid dependent or has a history of corticosteroid dependency
AND
b)Has not previously received an approved biologic forCD(ie, infliximab, adalimumab, certolizumab pegol, ustekinumab, natalizumab, vedolizumab or approved biosimilars of these agents)
6.Pt on oral corticosteroids (eg, prednisone, budesonide) at a prednisone-equivalent dose of=40milligram (mg)/day or=9mg/day of budesonide are permitted provided doses meeting these requirements are stable for3weeks prior to baseline(Week 0)or these have been discontinued at least3weeks prior to baseline
7.Pt on the immunomodulators AZA, 6-MP, or MTX at screening, must discontinue these medications at least3weeks prior to baseline
8.Has screening lab test results within the following parameters:Hb=8.5g/dL,White blood cells(WBC)>3.5x103/µL,Neutrophils>1.5x103/µL,Platelets>100x103/µL,Serum creatinine<1.7mg/dL,AST and ALT concentrations:Within2times the upper limit of normal range for the lab conducting the test,Direct(conjugated)bilirubin<1.0mg/dL
9.Is considered eligible per the following tuberculosis(TB)screening criteria:
a)Has no history of latent or active TB prior to screening; exceptions are made for a subject who:
•Is currently receiving treatment for latent TB without evidence of active TB (or has initiated treatment for latent TB prior to Week 0 study agent administration)
•Has a history of latent TB and documentation of having completed adequate treatment for latent TB within 5 years prior to the first administration of study agent.
It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide/obtain appropriate documentation.
b)Has no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
c)Has had no recent, known close contact with a person with active TB or, if there has been such contact, the subject is to be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to, or simultaneously with, the first administration of study agent.
d)Within2months prior to the first administration of study agent, either has:
•A negative QuantiFERON-TB Gold test, or
•A newly identified positive QuantiFERON-TB Gold test in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to, or simultaneously with, the first administration of study agent.
A subject whose first QuantiFERON-TB Gold test result is indeterminate should have the test repeated. In the event that additional QuantiFERON-TB Gold test result is per
1.Has complications ofCDthat are likely to require surgery or would confound the ability to assess the effect of ustekinumab or adalimumab treatment using theCDAI
2.Currently has, or is suspected to have, an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least3weeks prior to baseline, or8weeks prior for intra-abdominal abscesses, if there is no anticipated need for any further surgery.Pt with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses present
3.Has had any kind of bowel resection within6months prior to baseline or other intra-abdominal surgery or a hospital admission for bowel obstruction within3months prior to baseline
4.At any time received any monoclonal antibody(including biosimilars)targeting tumor necrosis factor alfa(TNFa),IL-12, or IL-23, or anti-integrin agents approved for CDor has received any of the following medications or therapies within the specified periods prior to baseline:
a)Any other investigational agent forCD,unless at least3months or5half-lives have elapsed since last dose
b)Intravenous corticosteroids as a treatment forCD<3weeks prior to baseline
c)Oral immunomodulatory agents other thanAZA,6-MPorMTX<4weeks prior to baseline
d)Treatment with apheresis or total parenteral nutrition(TPN)as a treatment for CD<3weeks prior to baseline
5.Has a stool culture or other examination positive for an enteric pathogen,including Clostridium difficile toxin, in the last4months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen
6.Has received a Bacillus Calmette–Guérin(BCG)vaccination within12months or any other live bacterial or live viral vaccination within2weeks of baseline
7.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
8.Has current signs or symptoms of infection,or recent (within8weeks prior to baseline)history of herpes zoster or serious infection(including any requiring hospitalization)
Established nonserious infections(eg, acute upper respiratory tract infection,simple urinary tract infection)need not be considered exclusionary at the discretion of the investigator
9.Has evidence of current active infection, includingTB,or a nodule suspicious for lung malignancy on screening or any other available chest radiograph,unless definitively resolved surgically or by additional imaging and with source document confirmation
10.Has a history of latent or active granulomatous infection,including histoplasmosis or coccidioidomycosis, prior to screening
11.Has ever had a nontuberculous mycobacterial infection or serious opportunistic infection(eg, cytomegalovirus causing colitis, Pneumocystis jiroveci, aspergillosis)
12.Is seropositive for antibodies to hepatitisC(HCV)without a history of clearance or successful treatment, defined as being negative for HCV RNA in the past year and,if treated,at least24weeks after completing antiviral treatment
13.Tests positive forHBsAg,regardless of the results of other hepatitisBtests.Pt who test positive only for anti-HBc must undergo further testing for HBV DNA test.If the HBV DNA test is positive, the pt is not eligible for this study. If the HBV DNA test is negative, the pt is e
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method