ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 17 of 22 for:    dry mouth AND Craniofacial | NIH

Pilot Study of Raptiva to Treat Sjogren's Syndrome

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: 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
Enrollment 10
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Raptiva Placebo
Hide Arm/Group Description 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. 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.
Period Title: Screening
Started 6 [1] 4
Completed 6 3
Not Completed 0 1
Reason Not Completed
Withdrawal by Subject             0             1
[1]
No randomization during the screening phase
Period Title: Double Blind, Placebo Controlled
Started 6 3
Completed 4 3
Not Completed 2 0
Reason Not Completed
Withdrawal by Subject             1             0
Study terminated             1             0
Period Title: Open Label
Started 4 3
Completed 2 2
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             1             1
Study terminated             1             0
Arm/Group Title Raptiva Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 3 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
3
 100.0%
9
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 3 participants 9 participants
51  (13.3) 53  (4.16) 53  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 3 participants 9 participants
Female
6
 100.0%
2
  66.7%
8
  88.9%
Male
0
   0.0%
1
  33.3%
1
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 3 participants 9 participants
6 3 9
1.Primary Outcome
Title Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks
Hide Description

Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.

  1. Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.
  2. Salivary gland biopsy:

    at least 2 points improvement in the focus score on MSG biopsy

  3. Tear flow:

at least 30% improvement in ophthalmic Oxford grading scheme or normalization of the scale as defined by score of 0 or 2mm improvement in Schirmer test as compared with the baseline in either eye.

Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Raptiva Placebo
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 6 3
Measure Type: Number
Unit of Measure: participant
0 1
Time Frame 2 years and 5 month
Adverse Event Reporting Description

Raptiva: AEs occuring in 6 patients receiving Raptiva durig the blinded phase plus the 2 patients who received placebo during the blinded phase but received Raptiva during the open lable phase.

Placebo AEs occuring in the placebo group (n=3) during the blinded phase. One patient withdrew after completing the placebo phase.

 
Arm/Group Title Raptiva Placebo
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Raptiva Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Raptiva Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/8 (0.00%)      0/3 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Raptiva Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/8 (100.00%)      3/3 (100.00%)    
Blood and lymphatic system disorders     
Lymphadenopathy   1/8 (12.50%)  1 0/3 (0.00%)  0
Monoclonal gammopathy  [1]  2/8 (25.00%)  2 0/3 (0.00%)  0
Thrombocytopenia   1/8 (12.50%)  1 0/3 (0.00%)  0
Oligoclonal gammopathy   3/8 (37.50%)  3 0/3 (0.00%)  0
Eye disorders     
Corneal scratches  [2]  2/8 (25.00%)  2 1/3 (33.33%)  1
Keratoconjunctivitis   2/8 (25.00%)  2 0/3 (0.00%)  0
Gastrointestinal disorders     
Diarrhea   1/8 (12.50%)  1 2/3 (66.67%)  5
Nausea   1/8 (12.50%)  1 1/3 (33.33%)  1
right upper quadrant pain   0/8 (0.00%)  0 1/3 (33.33%)  1
Dysphagia   1/8 (12.50%)  1 0/3 (0.00%)  0
General disorders     
Flulikr symptoms   0/8 (0.00%)  0 1/3 (33.33%)  1
Increased sweating   1/8 (12.50%)  1 0/3 (0.00%)  0
Parotid pain  [3]  1/8 (12.50%)  1 0/3 (0.00%)  0
Immune system disorders     
Increase in autoantibody titers   2/8 (25.00%)  2 1/3 (33.33%)  1
Infections and infestations     
Angular cheilitis   0/8 (0.00%)  0 1/3 (33.33%)  1
Infectious parotitis   1/8 (12.50%)  1 0/3 (0.00%)  0
Oral ulcers   6/8 (75.00%)  7 1/3 (33.33%)  1
Tooth abscess   1/8 (12.50%)  1 0/3 (0.00%)  0
Vaginal yeast infection   1/8 (12.50%)  1 1/3 (33.33%)  1
oral candidiasis   2/8 (25.00%)  2 0/3 (0.00%)  0
Metabolism and nutrition disorders     
Parotitis   3/8 (37.50%)  3 0/3 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Low back pain   1/8 (12.50%)  1 0/3 (0.00%)  0
Myalgia   1/8 (12.50%)  1 2/3 (66.67%)  2
Arthralgia   4/8 (50.00%)  4 0/3 (0.00%)  0
Nervous system disorders     
Headache   1/8 (12.50%)  1 0/3 (0.00%)  0
Renal and urinary disorders     
Dysuria   2/8 (25.00%)  2 0/3 (0.00%)  0
Reproductive system and breast disorders     
Vaginal dryness   2/8 (25.00%)  2 0/3 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Pleuritic chest pain   1/8 (12.50%)  1 0/3 (0.00%)  0
Sinusitis   1/8 (12.50%)  1 1/3 (33.33%) 
Upper respiratory infection   3/8 (37.50%)  4 1/3 (33.33%)  1
Skin and subcutaneous tissue disorders     
Rash   1/8 (12.50%)  1 1/3 (33.33%)  1
Indicates events were collected by systematic assessment
[1]
M-spike on immunefixation electrophoresis
[2]
Traumatic
[3]
on citric acid stimulation
Early termination due to serious adverse event described in psoriasis which led to the withdrawal of the drug from market.
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
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