Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01389973
First received: July 7, 2011
Last updated: October 14, 2014
Last verified: October 2014
Results First Received: August 19, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Primary Biliary Cirrhosis
Interventions: Drug: ustekinumab 90 mg
Drug: ustekinumab 45 mg
Drug: ustekinumab 180 mg
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study had 2 parts, Part 1 (proof of concept) and Part 2. As per the study design, the study was considered completed after part 1 and part 2 was not initiated. Results shown below are for Part 1 of the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Open-label: Ustekinumab 90 mg In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.

Participant Flow:   Overall Study
    Open-label: Ustekinumab 90 mg  
STARTED     20  
COMPLETED     0  
NOT COMPLETED     20  
Lost to Follow-up                 1  
Trial Stopped by Sponsor                 9  
Unspecified                 10  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Efficacy analysis set included all participants who received at least 1 administration of ustekinumab (full or partial).

Reporting Groups
  Description
Open-label: Ustekinumab 90 mg In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.

Baseline Measures
    Open-label: Ustekinumab 90 mg  
Number of Participants  
[units: participants]
  20  
Age  
[units: years]
Mean ± Standard Deviation
  48.8  ± 10.13  
Gender  
[units: participants]
 
Female     19  
Male     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Part 1: Number of Participants With Alkaline Phosphatase (ALP) Response at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   Part 1: Number of Participants With ALP Response at Week 28   [ Time Frame: Week 28 ]

3.  Secondary:   Part 1: Number of Participants With ALP Remission at Week 28   [ Time Frame: Week 28 ]

4.  Secondary:   Part 1: Percent Change From Baseline in ALP Concentration at Week 28   [ Time Frame: Baseline and Week 28 ]

5.  Secondary:   Part 1: Percent Change From Baseline in Alanine Aminotransferase, Aspartate Aminotransferase, and Bilirubin Concentration at Week 28   [ Time Frame: Baseline and Week 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Based on the efficacy results of Part 1, Part 2 of the study was not initiated and as per the study design, the study was considered completed after part 1.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Senior Director, Clinical Development, Immunology
Organization: Janssen, R&D, LLC, Spring House, PA
e-mail: ClinicalTrialDisclosure@its.jnj.com


No publications provided


Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01389973     History of Changes
Other Study ID Numbers: CR018748, CNTO1275PBC2001, 2011-000554-31
Study First Received: July 7, 2011
Results First Received: August 19, 2014
Last Updated: October 14, 2014
Health Authority: United States: Food and Drug Administration