A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)

Conditions

• Colitis
• Crohn's Disease
• IBD
• Inflammatory Bowel Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Placebo SC — DRUG
  Placebo will be administered subcutaneously.
• Placebo IV — DRUG
  Placebo will be administered as a single Intravenous infusion at week 0.
• Ustekinumab 90 mg SC q8w — DRUG
  Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
• Ustekinumab 130 mg IV — DRUG
  Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.
• Ustekinumab 90 mg SC q12w — DRUG
  Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Study Details

The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.

Key Dates

Start date

Sep 13, 2011

Status verified

Jan 2025

Primary completion

Jun 10, 2015

Completion

Oct 1, 2019

Study Design

Enrollment

1,282 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: 001
  Participants who were responders to Intravenous (IV) infusion of ustekinumab induction will be randomized to receive a single dose of placebo subcutaneously (SC) every 4 weeks (q4w).
• Experimental: 002
  Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 milligram (mg) SC every 12 weeks (q12w).
• Experimental: 003
  Participants who were responders to IV ustekinumab induction will be randomized to receive a single dose of ustekinumab 90 mg SC every 8 weeks (q8w).
• Experimental: 004
  Participants who were nonresponders to IV ustekinumab induction will receive a single dose of ustekinumab 90 mg SC and one placebo IV at week 0, if then respond will continue to receive one ustekinumab 90 mg SC q8w.
• Experimental: 005
  Participants who were nonresponders to IV placebo induction will receive a single dose of ustekinumab 130 mg IV and one placebo SC at week 0, if then respond will continue to receive one ustekinumab 90 mg SC at week 8 then q12w.
• Placebo Comparator: 006
  Participants who were responders to IV placebo induction will receive one dose of placebo SC q4w.

Primary Outcome Measure

Number of Participants With Clinical Remission at Week 44 [ Time Frame: Week 44 ]

Locations (77)

Find similar trials in Tucson, AZ

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