Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT03464136

Run by

Janssen Scientific Affairs, LLC

People needed

386

Starts

2018-03-29

Expected to finish

2021-05-21

Last updated by the study team

2025-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Precision Research Institute — San Diego, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Gastro Associates of Fairfield County PC — Bridgeport, Connecticut, United States
• Western Connecticut Health Network/Danbury Hospital — Danbury, Connecticut, United States
• Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Gastro Florida — Clearwater, Florida, United States
• Florida Research Network, LLC — Gainesville, Florida, United States
• Florida Center For Gastroenterology — Largo, Florida, United States
• Center for Advanced Gastroenterology — Maitland, Florida, United States
• Gastroenterology Group Of Naples — Naples, Florida, United States
• Advanced Medical Research Center — Port Orange, Florida, United States
• Apex Clinical Research — Tampa, Florida, United States
• Cleveland Clinic Florida — Weston, Florida, United States
• Atlanta Gastroenterology Specialists, PC — Suwanee, Georgia, United States
• Grand Teton Research Group, PLLC — Idaho Falls, Idaho, United States
• Health Science Research Center — Pratt, Kansas, United States
• Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States
• Gastroenterology Associates Of Hazard — Hazard, Kentucky, United States
• University of Louisville — Louisville, Kentucky, United States
• Texas Digestive Disease Consultants — Baton Rouge, Louisiana, United States
• CroNOLA, LLC — Houma, Louisiana, United States
• Louisiana Research Center, LLC — Shreveport, Louisiana, United States
• Chevy Chase Clinical Research — Chevy Chase, Maryland, United States
• Clinical Research Institute of Michigan, LLC — Chesterfield, Michigan, United States
• Alabama Medical Group — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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