Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

Conditions

• Crohn Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo for Ustekinumab — BIOLOGICAL
  Participants will receive placebo as SC injection to blind adalimumab.
• Placebo for Adalimumab — BIOLOGICAL
  Participants will receive placebo as IV infusion to blind ustekinumab.
• Ustekinumab (6 mg/kg) — BIOLOGICAL
  Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
• Ustekinumab (90 mg) — BIOLOGICAL
  Participants will self-administer SC injection of ustekinumab 90 mg.
• Adalimumab (40 mg) — BIOLOGICAL
  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.

Study Details

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 Dates

Start date

Mar 29, 2018

Status verified

Apr 2025

Primary completion

Dec 15, 2020

Completion

May 21, 2021

Study Design

Enrollment

386 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1 (Ustekinumab)
  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.
• Active Comparator: Group 2 (Adalimumab)
  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.

Primary Outcome Measure

Percentage of Participants With Clinical Remission at Week 52 [ Time Frame: Week 52 ]

Locations (67)

Find similar trials in Mobile, AL

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