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IL1-TRAP, Rilonacept, in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT01538719
Recruitment Status : Completed
First Posted : February 24, 2012
Results First Posted : May 1, 2018
Last Update Posted : May 1, 2018
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Robert Simms, Boston University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Scleroderma
Systemic Sclerosis
Diffuse Scleroderma
Diffuse Systemic Sclerosis
Interventions: Drug: Rilonacept
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2 subjects withdrew consent and 3 found to be ineligible, leaving 19 for randomization.

Reporting Groups
  Description
Placebo

2:1 randomization

Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks

Rilonacept

2:1 randomization

Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks


Participant Flow:   Overall Study
    Placebo   Rilonacept
STARTED   7   12 
COMPLETED   5   12 
NOT COMPLETED   2   0 
Lost to Follow-up                2                0 



  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

2:1 randomization

Placebo: Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks

Rilonacept

2:1 randomization

Rilonacept: Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks

Total Total of all reporting groups

Baseline Measures
   Placebo   Rilonacept   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   12   19 
Age 
[Units: Years]
Mean (Standard Deviation)
 49.86  (11.10)   51.33  (7.33)   50.79  (8.63) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  28.6%      7  58.3%      9  47.4% 
Male      5  71.4%      5  41.7%      10  52.6% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   7   12   19 


  Outcome Measures

1.  Primary:   Change in 2- Gene Biomarker   [ Time Frame: Visit 3 (Day 42) - Visit 1 (Day 0) ]

2.  Secondary:   Change in Modified Rodnan Skin Score   [ Time Frame: Visit 3 (Day 42) - Visit 1 (Day 0) ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Eric A Stratton, Sr. Clinical Research Manager
Organization: Boston University School of Medicine
phone: 6174142507
e-mail: eas@bu.edu



Responsible Party: Robert Simms, Boston University
ClinicalTrials.gov Identifier: NCT01538719     History of Changes
Other Study ID Numbers: H31332
First Submitted: February 21, 2012
First Posted: February 24, 2012
Results First Submitted: January 5, 2018
Results First Posted: May 1, 2018
Last Update Posted: May 1, 2018