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NCT00344448 · ClinicalTrials.gov registry record · Phase 2
Pilot Study of Raptiva to Treat Sjogren's Syndrome
A Phase 2 study, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- Terminated
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
NCT00344448 is a Phase 2 study that was terminated before completion, run by National Institute of Dental and Craniofacial Research (NIDCR). The registered enrollment target is 10 participants.
The verdict
NCT00344448, a Phase 2 study, was terminated before completion, sponsored by National Institute of Dental and Craniofacial Research (NIDCR).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
Study Summary
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
Interventions
- DRUG Raptiva
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2006-06 |
| Est. Completion | 2009-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00344448
The ClinicalTrials.gov registry entry for NCT00344448 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Raptiva is the first listed.
NCT00344448 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00344448 about?
NCT00344448 is a clinical study titled "Pilot Study of Raptiva to Treat Sjogren's Syndrome". 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 Adminis...
What is the current status of trial NCT00344448?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2006-06. Estimated completion is 2009-01.
What interventions are being tested in trial NCT00344448?
The interventions under investigation include: Raptiva (DRUG).
Who is sponsoring clinical trial NCT00344448?
This trial is sponsored by National Institute of Dental and Craniofacial Research (NIDCR), which has 91 total clinical trials registered on ClinicalTrials.gov.
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