Trial Outcomes & Findings for Pilot Study of Raptiva to Treat Sjogren's Syndrome (NCT NCT00344448)

Last Updated: 2015-12-21

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

10 participants

Primary outcome timeframe

3 months

Results posted on

2015-12-21

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Screening STARTED	6	4
Screening COMPLETED	6	3
Screening NOT COMPLETED	0	1
Double Blind, Placebo Controlled STARTED	6	3
Double Blind, Placebo Controlled COMPLETED	4	3
Double Blind, Placebo Controlled NOT COMPLETED	2	0
Open Label STARTED	4	3
Open Label COMPLETED	2	2
Open Label NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Screening Withdrawal by Subject	0	1
Double Blind, Placebo Controlled Withdrawal by Subject	1	0
Double Blind, Placebo Controlled Study terminated	1	0
Open Label Withdrawal by Subject	1	1
Open Label Study terminated	1	0

Baseline Characteristics

Pilot Study of Raptiva to Treat Sjogren's Syndrome

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raptiva n=6 Participants 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 n=3 Participants 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 n=9 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 13.3 • n=5 Participants	53 years STANDARD_DEVIATION 4.16 • n=7 Participants	53 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	6 participants n=5 Participants	3 participants n=7 Participants	9 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Raptiva n=6 Participants 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 n=3 Participants 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.
Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks	0 participant	1 participant

Adverse Events

Raptiva

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Gabor G Illei, Md, principal Investigator

National Institute of Dental and Craniofacial Research

Phone: 301 496-4072

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Raptiva n=8 participants at risk 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 n=3 participants at risk 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.
Infections and infestations Angular cheilitis	0.00% 0/8 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Eye disorders Corneal scratches	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	66.7% 2/3 • Number of events 5 • 2 years and 5 month 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.
Renal and urinary disorders Dysuria	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
General disorders Flulikr symptoms	0.00% 0/8 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Immune system disorders Increase in autoantibody titers	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
General disorders Increased sweating	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Infections and infestations Infectious parotitis	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Eye disorders Keratoconjunctivitis	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Musculoskeletal and connective tissue disorders Low back pain	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Blood and lymphatic system disorders Lymphadenopathy	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Blood and lymphatic system disorders Monoclonal gammopathy	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	66.7% 2/3 • Number of events 2 • 2 years and 5 month 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.
Gastrointestinal disorders Nausea	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Infections and infestations Oral ulcers	75.0% 6/8 • Number of events 7 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Respiratory, thoracic and mediastinal disorders Pleuritic chest pain	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Respiratory, thoracic and mediastinal disorders Sinusitis	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	33.3% 1/3 • 2 years and 5 month 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.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Infections and infestations Tooth abscess	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	37.5% 3/8 • Number of events 4 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Reproductive system and breast disorders Vaginal dryness	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Infections and infestations Vaginal yeast infection	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Gastrointestinal disorders right upper quadrant pain	0.00% 0/8 • 2 years and 5 month 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.	33.3% 1/3 • Number of events 1 • 2 years and 5 month 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.
Musculoskeletal and connective tissue disorders Arthralgia	50.0% 4/8 • Number of events 4 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Blood and lymphatic system disorders Oligoclonal gammopathy	37.5% 3/8 • Number of events 3 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Infections and infestations oral candidiasis	25.0% 2/8 • Number of events 2 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Gastrointestinal disorders Dysphagia	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
General disorders Parotid pain	12.5% 1/8 • Number of events 1 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.
Metabolism and nutrition disorders Parotitis	37.5% 3/8 • Number of events 3 • 2 years and 5 month 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.	0.00% 0/3 • 2 years and 5 month 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.