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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01369355




Registration number
NCT01369355
Ethics application status
Date submitted
7/06/2011
Date registered
8/06/2011
Date last updated
22/10/2020

Titles & IDs
Public title
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
Scientific title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease
Secondary ID [1] 0 0
CNTO1275CRD3003
Secondary ID [2] 0 0
CR018421
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 0 0
Colitis 0 0
IBD 0 0
Inflammatory Bowel Disease 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Crohn's disease
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Placebo SC
Treatment: Drugs - Placebo IV
Treatment: Drugs - Ustekinumab 90 mg SC q8w
Treatment: Drugs - Ustekinumab 130 mg IV
Treatment: Drugs - Ustekinumab 90 mg SC q12w

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.


Treatment: Drugs: Placebo SC
Placebo will be administered subcutaneously.

Treatment: Drugs: Placebo IV
Placebo will be administered as a single Intravenous infusion at week 0.

Treatment: Drugs: Ustekinumab 90 mg SC q8w
Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.

Treatment: Drugs: Ustekinumab 130 mg IV
Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.

Treatment: Drugs: Ustekinumab 90 mg SC q12w
Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Clinical Remission at Week 44 - Clinical remission at Week 44 was defined as a Crohn's Disease Activity Index (CDAI) score of <150 points (in general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities). CDAI was assessed by collecting information on 8 different Crohn's disease-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). A decrease in CDAI over time indicates improvement in disease activity.
Timepoint [1] 0 0
Week 44
Secondary outcome [1] 0 0
Number of Participants With Clinical Response at Week 44 - Clinical response at Week 44 was defined as a reduction from baseline in the Crohn's Disease Activity Index (CDAI) score of greater than or equal (>=) 100 points. Participants with a baseline CDAI score of > = 220 to less than or equal (< =) 248 were considered to be in clinical response if a CDAI score of less than (<) 150 was attained. A CDAI score of less than 150 indicates clinical remission. A decrease in CDAI score over time indicates improvement in disease activity.
Timepoint [1] 0 0
Week 44
Secondary outcome [2] 0 0
Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study - Clinical remission at week 44 was defined as a CDAI score of < 150 points among participants in clinical remission to ustekinumab at week 0 of maintenance study.
Timepoint [2] 0 0
Week 44
Secondary outcome [3] 0 0
Number of Participants With Corticosteroid-free Remission at Week 44 - Corticosteroid-free remission at Week 44 was defined as a CDAI score of <150 points without receiving corticosteroids at Week 44.
Timepoint [3] 0 0
Week 44
Secondary outcome [4] 0 0
Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy - Clinical remission at Week 44 was defined as a CDAI score of <150 points in the subset of participants who were refractory or Intolerant to tumor necrosis factor antagonist therapy.
Timepoint [4] 0 0
Week 44

Eligibility
Key inclusion criteria
- Patients who received study agent at the start of study CNTO1275CRD3001 or
CNTO1275CRD3002 and completed the Week 8 visit.
Minimum age
18 Years
Maximum age
99 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients who underwent a Crohn's disease-related surgery since the start of induction
study CNTO1275CRD3001 or CNTO1275CRD3002

- Patients who started a protocol prohibited medication since the start of studies
CNTO1275CRD3001 and CNTO1275CRD3002

- Patients with protocol-specified changes to their concomitant medications due to
Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001
and CNTO1275CRD3002

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
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- Adelaide
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- Bedford Park
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- Box Hill
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- Central Queensland M C
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- Concord
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- Garran
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- Liverpool
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- Malvern
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- Parkville
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- Adelaide
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- Bedford Park
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- Box Hill
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- Central Queensland M C
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- Concord
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- Garran
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- Liverpool
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- Malvern
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- Parkville
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Pretoria
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT01369355
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications