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COMPLETED Phase 3

Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

NCT03464136 · View on ClinicalTrials.gov ↗

Study 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.

Conditions Studied

Interventions

  • BIOLOGICAL Placebo for Ustekinumab
  • BIOLOGICAL Placebo for Adalimumab
  • BIOLOGICAL Ustekinumab (6 mg/kg)
  • BIOLOGICAL Ustekinumab (90 mg)
  • BIOLOGICAL Adalimumab (40 mg)

Study Locations (20)

Florida

  • Gastro Florida — Clearwater
  • Florida Research Network, LLC — Gainesville
  • Florida Center For Gastroenterology — Largo
  • Center for Advanced Gastroenterology — Maitland
  • Gastroenterology Group Of Naples — Naples
  • Advanced Medical Research Center — Port Orange
  • Apex Clinical Research — Tampa
  • Cleveland Clinic Florida — Weston

Kentucky

  • Tri-State Gastroenterology Assoc — Crestview Hills
  • Gastroenterology Associates Of Hazard — Hazard
  • University of Louisville — Louisville

Connecticut

  • Gastro Associates of Fairfield County PC — Bridgeport
  • Western Connecticut Health Network/Danbury Hospital — Danbury

Alabama

  • Alabama Medical Group — Mobile

California

  • Precision Research Institute — San Diego

Colorado

  • Peak Gastroenterology Associates — Colorado Springs

District of Columbia

  • Medstar Washington Hospital Center — Washington D.C.

Georgia

  • Atlanta Gastroenterology Specialists, PC — Suwanee

Trial Details

FieldValue
Enrollment Target 386 participants
Start Date 2018-03-29
Est. Completion 2021-05-21
Phase Phase 3

Sponsor

Janssen Scientific Affairs

10 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03464136

The ClinicalTrials.gov registry entry for NCT03464136 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 386 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Scientific Affairs, which has 10 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Crohn Disease appearing as the primary indexed condition, and to 5 interventions — of which Placebo for Ustekinumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03464136 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, Kentucky, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03464136 about?

NCT03464136 is a clinical study titled "Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year". 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...

What is the current status of trial NCT03464136?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 386 participants. The study started on 2018-03-29. Estimated completion is 2021-05-21.

What conditions does trial NCT03464136 study?

This clinical trial studies the following conditions: Crohn Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03464136?

The interventions under investigation include: Placebo for Ustekinumab (BIOLOGICAL), Placebo for Adalimumab (BIOLOGICAL), Ustekinumab (6 mg/kg) (BIOLOGICAL), Ustekinumab (90 mg) (BIOLOGICAL), Adalimumab (40 mg) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03464136?

This trial is sponsored by Janssen Scientific Affairs, which has 10 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03464136 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial