A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 99 Years

Healthy Volunteers

Not accepted

Interventions

• Group 1: Placebo — DRUG
  Form=solution for injection, route=intravenous use, in a single dose.
• Group 2 ustekinumab 130 mg — DRUG
  Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
• Group 3: ustekinumab approximately 6 mg/kg — DRUG
  Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg), 390 mg (weight \> 55 kg and \<= 85 kg), and 520 mg (weight \> 85 kg).

Study Details

This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.

Key Dates

Start date

Jul 31, 2011

Status verified

Nov 2016

Primary completion

Aug 31, 2014

Completion

Oct 31, 2014

Study Design

Enrollment

640 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo IV
  Group 1: Placebo Form=solution for injection route=intravenous use in a single dose.
• Experimental: Ustekinumab 130 milligram (mg)
  Group 2 ustekinumab 130 mg Type=exact unit=mg number=130 form=solution for injection route= intravenous use in a single dose.
• Experimental: Ustekinumab approximately (~) 6 milligram per kilogram (mg/kg)
  Group 3: ustekinumab approximately 6 mg/kg Type=range unit=mg/kg number=6 form=solution for injection route= intravenous use in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight \<= 55 kg) 390 mg (weight \> 55 kg and \<= 85 kg) and 520 mg (weight \> 85 kg).

Primary Outcome Measure

Number of Participants With Clinical Response at Week 6 [ Time Frame: Week 6 ]

Locations (84)

Find similar trials in Tucson, AZ

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