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Pilot Study of Raptiva to Treat Sjogren's Syndrome

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ClinicalTrials.gov Identifier: NCT00344448
Recruitment Status : Terminated (Increased risk of PML associated with raptiva in other studies)
First Posted : June 26, 2006
Results First Posted : December 21, 2015
Last Update Posted : December 21, 2015
Sponsor:
Information provided by (Responsible Party):
Gabor Illei, M.D., National Institutes of Health Clinical Center (CC)

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Sjogren's Syndrome
Intervention: Drug: Raptiva

  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
Raptiva At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
Placebo Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.

Participant Flow for 3 periods

Period 1:   Screening
    Raptiva   Placebo
STARTED   6 [1]   4 
COMPLETED   6   3 
NOT COMPLETED   0   1 
Withdrawal by Subject                0                1 
[1] No randomization during the screening phase

Period 2:   Double Blind, Placebo Controlled
    Raptiva   Placebo
STARTED   6   3 
COMPLETED   4   3 
NOT COMPLETED   2   0 
Withdrawal by Subject                1                0 
Study terminated                1                0 

Period 3:   Open Label
    Raptiva   Placebo
STARTED   4   3 
COMPLETED   2   2 
NOT COMPLETED   2   1 
Withdrawal by Subject                1                1 
Study terminated                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
Raptiva At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
Placebo Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
Total Total of all reporting groups

Baseline Measures
   Raptiva   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 6   3   9 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   6   3   9 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (13.3)   53  (4.16)   53  (11.2) 
Gender 
[Units: Participants]
     
Female   6   2   8 
Male   0   1   1 
Region of Enrollment 
[Units: Participants]
     
United States   6   3   9 


  Outcome Measures

1.  Primary:   Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks   [ Time Frame: 3 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
Early termination due to serious adverse event described in psoriasis which led to the withdrawal of the drug from market.


  More Information

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


Results Point of Contact:  
Name/Title: Gabor G Illei, Md, principal Investigator
Organization: National Institute of Dental and Craniofacial Research
phone: 301 496-4072
e-mail: illeig@mail.nih.gov


Publications:

Responsible Party: Gabor Illei, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00344448     History of Changes
Other Study ID Numbers: 060181
06-D-0181 ( Other Identifier: The National Institutes of Health )
First Submitted: June 23, 2006
First Posted: June 26, 2006
Results First Submitted: February 14, 2011
Results First Posted: December 21, 2015
Last Update Posted: December 21, 2015