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A Study of the Safety and Efficacy of Ustekinumab in Adolescent Patients With Psoriasis (CADMUS)

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ClinicalTrials.gov Identifier: NCT01090427
Recruitment Status : Completed
First Posted : March 22, 2010
Results First Posted : December 18, 2014
Last Update Posted : January 29, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Psoriasis
Interventions: Drug: Ustekinumab - Half-Standard Dosage
Drug: Ustekinumab - Standard Dosage
Other: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 110 volunteers from 10 countries were randomized and treated in this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 110 participants started and completed the first period in the study (ie, controlled period [CP] and entered the 2nd period (ie, After the Controlled Period [after CP]); however, only 101 of the 110 participants completed the 2nd period (after CP) of the study.

Reporting Groups
  Description
Placebo (CP) Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
Ustekinumab Half-Standard Dosage (CP) Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
Ustekinumab Standard Dosage (CP) Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
Placebo -> Ustekinumab Half-Standard Dosage (After CP) After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
Placebo -> Ustekinumab Standard Dosage (After CP) After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
Ustekinumab Half-Standard Dosage (After CP) After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
Ustekinumab Standard Dosage (After CP) After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.

Participant Flow for 2 periods

Period 1:   Controlled Period
    Placebo (CP)   Ustekinumab Half-Standard Dosage (CP)   Ustekinumab Standard Dosage (CP)   Placebo -> Ustekinumab Half-Standard Dosage (After CP)   Placebo -> Ustekinumab Standard Dosage (After CP)   Ustekinumab Half-Standard Dosage (After CP)   Ustekinumab Standard Dosage (After CP)
STARTED   37   37   36   0 [1]   0 [1]   0 [1]   0 [1] 
COMPLETED   37   37   36   0   0   0   0 
NOT COMPLETED   0   0   0   0   0   0   0 
[1] "0" in column indicates this reporting group is not relevant to Control Period.

Period 2:   After Controlled Period
    Placebo (CP)   Ustekinumab Half-Standard Dosage (CP)   Ustekinumab Standard Dosage (CP)   Placebo -> Ustekinumab Half-Standard Dosage (After CP)   Placebo -> Ustekinumab Standard Dosage (After CP)   Ustekinumab Half-Standard Dosage (After CP)   Ustekinumab Standard Dosage (After CP)
STARTED   0 [1]   0 [1]   0 [1]   19   18   37   36 
COMPLETED   0   0   0   17   18   32   34 
NOT COMPLETED   0   0   0   2   0   5   2 
Death                0                0                0                0                0                1                0 
Lack of Efficacy                0                0                0                0                0                3                2 
Adverse Event                0                0                0                2                0                1                0 
[1] "0" in column indicates this reporting group is not relevant to after Control Period.



  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.
No text entered.

Reporting Groups
  Description
Placebo Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
Ustekinumab Half-Standard Dosage Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Ustekinumab Standard Dosage Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
Total Total of all reporting groups

Baseline Measures
   Placebo   Ustekinumab Half-Standard Dosage   Ustekinumab Standard Dosage   Total 
Overall Participants Analyzed 
[Units: Participants]
 37   37   36   110 
Age 
[Units: Years]
Mean (Standard Deviation)
 15.6  (1.46)   15.1  (1.7)   14.8  (1.73)   15.2  (1.65) 
Gender 
[Units: Participants]
       
Female   17   19   20   56 
Male   20   18   16   54 
Age 
[Units: Participants]
       
12-15 years   15   20   20   55 
16-17 years   22   17   16   55 


  Outcome Measures

1.  Primary:   The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) or Minimal (1) at Week 12   [ Time Frame: Week 12 ]

2.  Secondary:   The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 75 Response at Week 12   [ Time Frame: Week 12 ]

3.  Secondary:   Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) Score at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups   [ Time Frame: Baseline; Week 12 ]

4.  Secondary:   The Percentage of Participants Achieving a Psoriasis Area and Severity Index (PASI) 90 Response at Week 12 Compared Between the Placebo Group and the Ustekinumab Treatment Groups   [ Time Frame: Week 12 ]

5.  Secondary:   The Percentage of Participants Achieving a Physician's Global Assessment (PGA) Score of Cleared (0) and PGA Score of Mild or Better (<=2) at Week 12   [ Time Frame: Week 12 ]

6.  Secondary:   The Percentage of Participants Who Were PASI 50 Responders and the Percentage of Participants With a PASI Score of 0 at Week 12   [ Time Frame: Week 12 ]

7.  Secondary:   The Change From Baseline in Pediatric Quality of Life Inventory (PedsQL) Total Scale Score, Psychosocial Health Summary Score, and Physical Health Summary Score at Week 12   [ Time Frame: Week 12 ]

8.  Secondary:   The Percentage of Participants With CDLQI Scores of 0 or 1 at Week 12 for Randomized Participants With a Baseline CDLQI Score > 1   [ Time Frame: Week 12 ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  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 less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
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.


Results Point of Contact:  
Name/Title: VICE PRESIDENT IMMUNOLOGY
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01090427     History of Changes
Obsolete Identifiers: NCT02166203
Other Study ID Numbers: CR017053
CNTO1275PSO3006 ( Other Identifier: Janssen Research & Development, LLC )
CADMUS ( Other Identifier: Janssen Research & Development, LLC )
2009-014368-20 ( EudraCT Number )
First Submitted: March 18, 2010
First Posted: March 22, 2010
Results First Submitted: December 10, 2014
Results First Posted: December 18, 2014
Last Update Posted: January 29, 2015