A Study of RoActemra/Actemra (Tocilizumab) Versus Placebo in Patients With Systemic Sclerosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01532869
First received: February 10, 2012
Last updated: April 2, 2016
Last verified: April 2016
Results First Received: October 8, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Sclerosis, Systemic
Interventions: Drug: Placebo
Drug: tocilizumab [RoActemra/Actemra]

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The study consisted of two treatment period: Blinded-treatment period (first 48 weeks) and Open-label period (another 48 weeks). The data analyzed up to Week 24 and up to Week 48 (data cut-off date of 11 July 2014) were reported here.

Reporting Groups
  Description
Placebo Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for up to 48 weeks (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for another 48 weeks.
Tocilizumab Participants received TCZ (162 mg) by SC injection qw for up to 48 weeks (blinded-treatment period) and then in the open-label period for another 48 weeks.

Participant Flow for 2 periods

Period 1:   Blinded-Treatment Period (Up to Week 24)
    Placebo     Tocilizumab  
STARTED     44     43  
COMPLETED     36 [1]   35 [1]
NOT COMPLETED     8     8  
Death                 0                 1  
Adverse Event                 2                 3  
Lost to Follow-up                 0                 1  
Non-compliance                 1                 0  
Lack of Efficacy                 1                 1  
Withdrawal by Subject                 4                 2  
[1] Number of participants who completed the first 24 weeks of full 48 weeks blinded-treatment period.

Period 2:   Blinded-Treatment Period (Up to Week 48)
    Placebo     Tocilizumab  
STARTED     44     43  
COMPLETED     33 [1]   30 [1]
NOT COMPLETED     11     13  
Death                 0                 3  
Adverse Event                 4                 5  
Lost to Follow-up                 0                 1  
Non-Compliance                 1                 0  
Lack of Efficacy                 0                 1  
Withdrawal by Subject                 5                 3  
Physician Decision                 1                 0  
[1] Number of participants who completed 48 weeks of blinded-treatment period.



  Baseline Characteristics
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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.
Safety population included all participants who received any study drug and provided at least one post-dose safety assessment (withdrawal, adverse event [AE], death, laboratory assessment, vital signs).

Reporting Groups
  Description
Placebo Participants received TCZ matched placebo by SC injection qw for up to 48 weeks (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for another 48 weeks.
Tocilizumab Participants received TCZ (162 mg) by SC injection qw for up to 48 weeks (blinded-treatment period) and then in the open-label period for another 48 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     Tocilizumab     Total  
Number of Participants  
[units: participants]
  44     43     87  
Age  
[units: years]
Mean (Standard Deviation)
  48.1  (12.9)     51.2  (11.7)     49.6  (12.3)  
Gender  
[units: participants]
     
Female     35     32     67  
Male     9     11     20  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Primary:   Percentage of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Week 48 ]

3.  Secondary:   Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI)   [ Time Frame: Baseline, Weeks 24 and 48 ]

4.  Secondary:   Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24 and 48 ]

5.  Secondary:   Change From Baseline in Clinician’s Global Assessment at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24 and 48 ]

6.  Secondary:   Change From Baseline in Patient’s Global Assessment at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24 and 48 ]

7.  Secondary:   Change From Baseline in Functional Assessment of Chronic Illness Therapy−Fatigue (FACIT-Fatigue) Score at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24 and 48 ]

8.  Secondary:   Change From Baseline in 5-D Itch Scale at Week 24 and Week 48   [ Time Frame: Baseline, Weeks 24 and 48 ]

9.  Secondary:   Change From Baseline in mRSS at Week 48   [ Time Frame: Baseline, Week 48 ]

10.  Secondary:   Percentage of Participants Who Maintained or Improved in mRSS From Week 24 to Week 48   [ Time Frame: Week 48 ]

11.  Secondary:   Change From Baseline in Tender Joint Count 28 (TJC28)   [ Time Frame: Baseline, Weeks 3, 8, 16, 24, 32, 40, and 48 ]

12.  Secondary:   Area Under the Concentration-Time Curve (AUC) From Time 0 to 168 Hour (AUC0-168)   [ Time Frame: Pre-dose, 24, 48, 72, 96, 120 or 144, and 168 hours post dose for Baseline and Week 16 ]

13.  Secondary:   Mean Serum Concentrations of Interleukin (IL)-6 by Visit   [ Time Frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48 ]

14.  Secondary:   Mean Serum Concentrations of Soluble IL-6 Receptor (R) by Visit   [ Time Frame: Baseline, Weeks 1, 2, 3, 8, 16, 24, and 48 ]

15.  Secondary:   Percentage of Participants With Anti-Tocilizumab Antibody   [ Time Frame: Baseline, and post-baseline (up to Week 48) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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: Medical Communications
Organization: Hoffmann-LaRoche
phone: 800-821-8590
e-mail: genentech@druginfo.com


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01532869     History of Changes
Other Study ID Numbers: WA27788
2011-001460-22 ( EudraCT Number )
Study First Received: February 10, 2012
Results First Received: October 8, 2015
Last Updated: April 2, 2016
Health Authority: United States: Food and Drug Administration