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An Early Access Program For Ustekinumab In Participants With Moderately To Severely Active Crohn's Disease

NCT03362736 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2025-02-03

No results posted yet for this study

Summary

The purpose of this program is to provide early access to ustekinumab where it is commercially unavailable for the treatment of participants with moderately to severely active Crohn's disease who have failed treatment with conventional Crohn's disease therapy (example, immunomodulators or corticosteroids) and Tumor Necrosis Factor alpha (TNF alpha) antagonist therapy (e.g., infliximab, adalimumab, certolizumab pegol, or their biosimilars), or who are intolerant to, or have a contraindication to these treatments. During the course of this early access program (EAP), through the reporting of serious adverse events (SAEs) and non-serious adverse drug reactions (ADRs) by participating physicians, information on the safety and tolerability of ustekinumab will be captured.

Conditions

  • Crohn Disease

Interventions

DRUG

Ustekinumab

All participants will receive a single intravenous (IV) tiered dose of ustekinumab based on body weight at Week 0 (participants less than or equal to \[\<=\] 55 kilogram \[kg\] will receive 260 milligram \[mg\] ustekinumab; \> 55 kg to \<= 85 kg will receive 390 mg ustekinumab; and \> 85 kg will receive 520 mg ustekinumab infusion) during induction period. After the IV induction dose, all participants will receive the first maintenance dose of 90 mg ustekinumab subcutaneous (SC) injection 8 weeks later (Week 8). The participants with adequate response based on the physician's judgement will be subsequently treated with 90 mg ustekinumab SC injection with every 12 weeks through Week 80 and participants with an inadequate response to ustekinumab dosing every 12 weeks based on the physician's judgement will be subsequently treated with 90 mg of ustekinumab every 8 weeks through Week 80.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Brazil

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362736 on ClinicalTrials.gov