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A Study to Evaluate the Safety and Efficacy of Abatacept in Patients With Diffuse Systemic Sclerosis (Scleroderma)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00442611
Recruitment Status : Completed
First Posted : March 2, 2007
Results First Posted : April 24, 2015
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Reporting Groups
  Description
Abatacept Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
IV Fluid Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.

Participant Flow:   Overall Study
    Abatacept   IV Fluid
STARTED   7   3 
COMPLETED   6   3 
NOT COMPLETED   1   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
Abatacept Abatacept (dosed based upon weight) administered intravenously (IV) on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
IV Fluid Placebo to match abatacept (IV fluid) administered on days 1, 15, 30 and monthly thereafter for a total of 7 doses.
Total Total of all reporting groups

Baseline Measures
   Abatacept   IV Fluid   Total 
Overall Participants Analyzed 
[Units: Participants]
 7   3   10 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.8  (11.4)   48.6  (13.9)   44.2  (12.5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      5  71.4%      3 100.0%      8  80.0% 
Male      2  28.6%      0   0.0%      2  20.0% 
Region of Enrollment 
[Units: Participants]
     
United States   7   3   10 


  Outcome Measures

1.  Primary:   Change in Modified Rodnan Skin Score   [ Time Frame: 6 months ]

2.  Secondary:   Oral Aperture at Baseline and Month 6   [ Time Frame: Baseline; Month 6 ]

3.  Secondary:   Hand Extension at Baseline and Month 6   [ Time Frame: Baseline; Month 6 ]

4.  Secondary:   Digital Ulcerations at Baseline and Month 6   [ Time Frame: Baseline; Month 6 ]

5.  Secondary:   Change in Pulmonary Function Tests   [ Time Frame: 6 months ]

6.  Secondary:   Change in Scleroderma Health Assessment Questionnaire   [ Time Frame: 6 months ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Dr. Lorinda Chung
Organization: Stanford University
phone: (650)493-5000 ext 6242
e-mail: shauwai@stanford.edu


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

Responsible Party: Lorinda S Chung, Stanford University
ClinicalTrials.gov Identifier: NCT00442611     History of Changes
Other Study ID Numbers: 100 186
First Submitted: March 1, 2007
First Posted: March 2, 2007
Results First Submitted: January 26, 2015
Results First Posted: April 24, 2015
Last Update Posted: October 31, 2017