Protocol Number: 06-D-0181

Title:

A Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients with Sjogren's Syndrome

Number:

06-D-0181

Summary:

This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjogren's syndrome, an autoimmune disease that mainly affects the glands producing saliva and tears. The cause of Sjogren's syndrome is not known, but inflammation plays an important role in the disease. Raptiva is approved by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease.

Patients 18 years of age of age and older with Sjogren's syndrome may be eligible for this study. Candidates are screened with a history and physical examination, chest x-ray, and oral and eye examinations.

Participants are randomly assigned to receive either Raptiva or placebo (an inactive substance that looks like Raptiva) for the first 3 months of the study. For the next 3 months, all participants receive Raptiva. Both Raptiva and placebo are injected under the skin once a week. During treatment and for 2 months after treatment, patients are evaluated as follows:

Full comprehensive evaluations (at the beginning of the study, at week 13, at week 25 and 2 months after treatment ends):

-Physical examination and blood draw.

-Saliva collection. Saliva samples are collected in two ways: 1) suctions cups connected to collection tubes are placed over the salivary gland ducts in the mouth and under the tongue; and 2) a sour-tasting liquid is applied to the top and sides of the tongue at 30-second intervals to stimulate saliva production.

-Eye exam to evaluate tear gland function.

-Questionnaires about mouth and eye dryness, energy level and overall well being.

-Lip biopsy (at screening and week 13 visits only). A few minor salivary glands under the skin of the lower lip are removed for examination under a microscope. The lower lip is numbed, a small cut is made, and several tiny glands are removed. The cut is then closed with a few tiny stitches that are removed after 5 to 7 days.

-Magnetic resonance imaging (MRI) of the parotid glands (salivary glands near the ear) at weeks 1, 13 and 25. The patient lies on a stretcher that is moved into the scanner (a narrow metal cylinder containing a strong magnetic field). The head is held in place during the scan with a plastic strap and foam pads. The study lasts about 90 minutes.

Short evaluations (at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends):

-Medical history and physical examination, blood draw, evaluation for changes in symptoms and side effects, review of current medications at weeks 3, 9, 15 and 21

-Laboratory tests, evaluation for changes in symptoms and side effects, review of current medications, saliva collection without the sour liquid and short evaluation of tear production at weeks 5 and 17

-Blood tests at week 29.

Sponsoring Institute:

National Institute of Dental And Craniofacial Research (NIDCR)

Recruitment Detail

Type: Completed Study; data analyses ongoing

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Adhesion Molecule

Interventional Study

Immunomodulation

MRI

Autoimmunity

Recruitment Keyword(s):

Sjogren Syndrome

SS

Condition(s):

Sjogren's Syndrome

Investigational Drug(s):

None

Investigational Device(s):

None

Interventions:

Drug: Raptiva

Supporting Site:

National Institute of Dental and Craniofacial Research

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Skopouli FN, Moutsopoulos HM. Autoimmune epitheliitis: Sjogren's syndrome. Clin Exp Rheumatol. 1994 Nov-Dec;12 Suppl 11:S9-11.

Atkinson JC, Fox PC. Sjogren's syndrome: oral and dental considerations. J Am Dent Assoc. 1993 Mar;124(3):74-6, 78-82, 84-6.

Garcia-Carrasco M, Ramos-Casals M, Rosas J, Pallares L, Calvo-Alen J, Cervera R, Font J, Ingelmo M. Primary Sjogren syndrome: clinical and immunologic disease patterns in a cohort of 400 patients. Medicine (Baltimore). 2002 Jul;81(4):270-80.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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