Pilot Study of Raptiva to Treat Sjogren's Syndrome

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Sjogren's Syndrome

In brief

This study will examine the effect of the drug Raptiva (efalizumab) in patients with Sjögren's syndrome (SS), an autoimmune disease affecting the glands producing saliva \& tears. The cause of SS is not known, but inflammation plays an important role. Raptiva is approved by the Food and Drug Administration to treat psoriasis, an inflammatory skin disease. Patients 18 years of age \& older with SS may be eligible for this study. Candidates are screened with a history \& physical examination, chest x-ray, and oral \& 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 \& placebo are injected under the skin once a week. Evaluation during treatment \& for 2 months after treatment as follows: Full comprehensive evaluations (beginning of the study, at weeks 13 \& 25 and 2 months after treatment ends): * Physical examination \& blood draw. * Saliva collection done 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 \& sides of the tongue at 30-second intervals to stimulate saliva production. * Eye exam for tear gland function. * Questionnaires about mouth \& eye dryness, energy level and overall well-being. * Lip biopsy (screening \& week 13 visits only). A few minor salivary glands are removed for examination under a microscope. The lower lip is numbed, a small cut is made on the inside of the lip, and several glands are removed. The cut is closed with a few stitches that are removed after 5 to 7 days. * Magnetic resonance imaging 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 metal cylinder containing a strong magnetic field). The head is held in place during the scan. The study lasts about 90 minutes. * Short evaluations at weeks 3, 5, 9, 15, 17, 21 and 1 month after treatment ends. * Medical history \& 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

Key facts

Study ID

NCT00344448

Run by

National Institute of Dental and Craniofacial Research (NIDCR)

People needed

10

Starts

2006-06-01

Expected to finish

2009-01-01

Last updated by the study team

2015-12-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Past head and neck irradiation.
• Hepatitis B, C, HIV, or HTLV infection.
• History of lymphoma or monoclonal gammopathy of unknown significance (MGUS).
• Sarcoidosis.
• Graft-versus-host disease.
• Women of childbearing potential are required to have a negative pregnancy test at screening.
• Women of childbearing potential and fertile men who are not practicing or who are unwilling to practice birth control during and for a period of three months after the completion of the study.
• Any therapy with human or murine antibodies or any experimental therapy within 3 months.
• Therapy with cyclophosphamide, pulse methylprednisolone or IVIg, azathioprine, mycophenolate mofetil, oral cyclosporine or methotrexate within 4 weeks of first study treatment.
• History of rituximab therapy.
• Prednisone dose greater than or equal to 10 mg/day.
• Allergy to murine or human antibodies.
• History of anaphylaxis.
• Serum creatinine greater than 2.0 mg/dl.
• History of any malignancy.
• Active infection that requires the use of intravenous antibiotics and does not resolve within 1 week of Day 1.
• Any active viral infection that does not resolve within 10 days prior to Day 1.
• WBC less than 2000/microL or ANC less than 1500/microL or Hgb less than 9.0 g/dL or platelets less than 150,000/microL or absolute lymphocyte count less than or equal to 500/microL.
• ALT and/or AST greater than 1.5x upper limit of normal (ULN) or alkaline phosphatase greater than 1.5x ULN.
• Significant concurrent medical condition that, in the opinion of the Principal Investigator, could affect the patient's ability to tolerate or complete the study.
• Live vaccines within 12 weeks of first treatment.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.