Sjogren's SyndromePhase 2NCT00344448
Pilot Study of Raptiva to Treat Sjogren's Syndrome
A Phase 2 study testing Raptiva in people with Sjogren's Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjogren's Syndrome
- What is being tested?
- Raptiva
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Up to 25 patients may be enrolled in this study to obtain at least 20 patients to complete the study and to allow for an estimated up to 20% early attrition rate. Eligible patients will have primary SS diagnosed according to the American-European Consensus Group Sjogren's Syndrome Classification Criteria. Subjects will be chosen based on their potential capacity to reverse the inflammatory process and at least partially recover the exocrine function in the salivary and lacrimal glands, as indicated in the inclusion criteria by requiring a minimal level of salivary flow as a marker of functional gland tissue. Pre-screening, which would include ophthalmologic evaluation, standard laboratory tests, and minor salivary gland biopsy, will be performed under the natural history protocol, and eligible patients will be offered to sign the informed consent for this protocol.
- Age at entry at least 18 years
- Must give written informed consent prior to entry in the protocol.
- Must fulfill at least 4 of the 6 following criteria for Primary SS as defined by the American-European Consensus Group Sjogren's Syndrome Classification Criteria, including either item IV or VI, or fulfill 3 of the 4 objective criteria (III, IV, V, VI) [53] :
- Ocular symptoms (at least one):
- Dry eyes greater than 3 months
Show all 39Show fewer
- Foreign body sensation in the eyes
- Use of artificial tears greater than 3x/day
- Oral symptoms (at least one):
- Dry mouth greater than 3 months
- Swollen salivary glands
- Need liquids to swallow dry foods
- Ocular signs (at least one):
- Schirmer test (without anesthesia) less than or equal to 5 mm/5 min
- Positive vital dye staining (van Bijsterveld greater than or equal to 4)
- Histopathology: Minor salivary gland biopsy showing focal lymphocyte sialoadenitis (focus score greater than or equal to 1 per 4 mm(2))
- Oral signs (at least one):
- Unstimulated whole salivary flow (less than or equal to 1.5 ml in 15 min)
- Abnormal parotid sialography
- Abnormal salivary scintigraphy
- Autoantibodies (at least one):
- Anti-SSA or Anti-SSB
- One or more of the following:
- Serum ANA level greater than or equal to 1EU
- Serum Anti-SSA level greater than or equal to 20EU
- Serum Anti-SSB level greater than or equal to 20EU
- Serum RF level greater than or equal to 20 IU/ml
- One or more of the following:
- ESR greater than 25 mm/hr for men; ESR greater than 42 mm/hr for women
- Serum IgG level greater than or equal to 1750 mg/dl
- Serum CRP level greater than or equal to 0.8 mg/dl
- Stimulated salivary flow of at least 0.1 ml/min.
- Minor salivary gland biopsy with a focus score of greater than or equal to 4 within at most 12 months prior to the study enrollment.
- Score of 3 or more on Oxford scale in at least one eye at the study entry.
- Negative age- and gender- appropriate malignancy screening for breast, cervical, colorectal cancer for women; and prostate and colorectal cancer for men. Specifically:
- All women: pelvic exam with Papanicolaou smear within one year of study entry.
- Women age 40 and older: mammogram within 1 year of study entry,
- Both genders age 50 and older; stool screening for occult blood within one year, or flexible sigmoidoscopy or colonoscopy within five years
- Men age 50 and older: rectal examination or prostate specific antigen testing
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: A Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With 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 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:
Read more
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
Read the detailed description
The LFA-1/ICAM-1 interaction is important in migration of lymphocytes to inflammatory sites, T-lymphocyte activation, antigen presentation, and maintaining the integrity of the immunologic synapse. In both murine and human Sjogren's Syndrome, increased expression of LFA-1 was found on activated lymphocytes, and increased expression of ICAM-1 was present on the activated endothelial cells in the diseased salivary and lacrimal glands. In animal models, blockade of the LFA-1/ICAM-1 interaction resulted in reduction of glandular inflammation.
Raptiva (efalizumab) is a recombinant humanized monoclonal antibody that binds to human CD11a, the alpha-subunit of Leukocyte Function Antigen-1 (LFA-1) and inhibits the LFA-1/ICAM-1 interaction. Raptiva is an FDA-approved medication for treatment of mild-to-moderate psoriasis.
In this pilot, proof of concept, randomized, double-blind, placebo-controlled study, up to 25 patients with Sjogren's syndrome may be enrolled. In the first, double-blind phase of the study, patients will be randomized and treated with weekly subcutaneous (SC) injections of either Raptiva (1mg/kg) or placebo for 12 weeks. In the second open label phase, all patients will be treated with weekly SC injections of Raptiva (1mg/kg) for another 12 weeks and then followed for an additional 8 weeks. Safety will be evaluated using standard clinical and laboratory parameters. To assess the potential effect of Raptiva on Sjogren's syndrome, minor salivary gland biopsy, oral and ocular evaluations, and measurements of surrogate markers of inflammation will be compared between the Raptiva and placebo treated groups before and after the treatment. Patients who either do not tolerate the drug or have worsening in their disease activity will be withdrawn from the protocol.
If Raptiva is well tolerated in this study and the treatment is associated with improvement in clinical parameters of Sjogren's Syndrome, further large studies of efficacy are planned.
- Conditions
- Sjogren's Syndrome
- Being tested
- Raptiva
- Keywords
- Adhesion Molecule, Interventional Study, Immunomodulation, Autoimmunity, Sjogren Syndrome, SS
- Medical subject headings
- Sjogren's Syndrome, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RaptivaDrug
Also called efalizumab, anti-CD11a monoclonal antibody
During the first phase of the study, subjects are randomized in a double blind fashion to receive weekly subcutaneous injections of efalizumab (Raptiva) or placebo (weeks 0-12). The second 12 weeks long phase is open label with all subjects receiving weekly subcutaneous injections of efalizumab.
| Study group | Role | What they receive |
|---|---|---|
| Raptiva | Experimental | 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. Receives: Drug: Raptiva |
| placebo | Placebo comparator | 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. Receives: Drug: Raptiva |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks
Patient will be considered a responder if (s)he demonstrates improvement in 2 / 3 disease activity measures without worsening of the third one.
- Salivary flow: 0.45 ml / 15 min improvement in unstimulated whole salivary flow from baseline value obtained at the study entry.
- Salivary gland biopsy: at least 2 points improvement in the focus score on MSG biopsy
- 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2009
- Study completionJan 2009
Why it stopped: Increased risk of PML associated with raptiva in other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Gabor Illei, M.D., National Institutes of Health Clinical Center (CC)
- Investigators
- Gabor G Illei, MD, PhD, MHS, Principal investigator, National Institute of Dental and Craniofacial Research (NIDCR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00344448
- Sponsor's protocol ID
- 060181
- Other IDs
- 06-D-0181
- Status last verified
- Nov 2015
- First submitted
- 23 Jun 2006
- Last updated
- 21 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Skopouli FN, Moutsopoulos HM. Autoimmune epitheliitis: Sjogren's syndrome. Clin Exp Rheumatol. 1994 Nov-Dec;12 Suppl 11:S9-11.
PubMed 7768059Atkinson JC, Fox PC. Sjogren's syndrome: oral and dental considerations. J Am Dent Assoc. 1993 Mar;124(3):74-6, 78-82, 84-6. doi: 10.14219/jada.archive.1993.0064.
PubMed 8335784Garcia-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. doi: 10.1097/00005792-200207000-00003. No abstract available.
PubMed 12169882
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With Sjogren's Syndrome
- ClinicalTrials.gov ID
- NCT00344448
- Acronym / sponsor ID
- 060181
- Conditions
- Sjogren's Syndrome
- Keywords
- Adhesion Molecule, Interventional Study, Immunomodulation, Autoimmunity, Sjogren Syndrome, SS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Increased risk of PML associated with raptiva in other studies
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Dental and Craniofacial Research (NIDCR)US National Institutes of Health
- Study start
- Jun 2006
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 26 Jun 2006 (estimated)
- Results
- Posted 21 Dec 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The LFA-1/ICAM-1 interaction is important in migration of lymphocytes to inflammatory sites, T-lymphocyte activation, antigen presentation, and maintaining the integrity of the immunologic synapse. In both murine and human Sjogren's Syndrome, increased expression of LFA-1 was found on activated lymphocytes, and increased expression of ICAM-1 was present on the activated endothelial cells in the diseased salivary and lacrimal glands. In animal models, blockade of the LFA-1/ICAM-1 interaction resulted in reduction of glandular inflammation.
Raptiva (efalizumab) is a recombinant humanized monoclonal antibody that binds to human CD11a, the alpha-subunit of Leukocyte Function Antigen-1 (LFA-1) and inhibits the LFA-1/ICAM-1 interaction. Raptiva is an FDA-approved medication for treatment of mild-to-moderate psoriasis.
In this pilot, proof of concept, randomized, double-blind, placebo-controlled study, up to 25 patients with Sjogren's syndrome may be enrolled. In the first, double-blind phase of the study, patients will be randomized and treated with weekly subcutaneous (SC) injections of either Raptiva (1mg/kg) or placebo for 12 weeks. In the second open label phase, all patients will be treated with weekly SC injections of Raptiva (1mg/kg) for another 12 weeks and then followed for an additional 8 weeks. Safety will be evaluated using standard clinical and laboratory parameters. To assess the potential effect of Raptiva on Sjogren's syndrome, minor salivary gland biopsy, oral and ocular evaluations, and measurements of surrogate markers of inflammation will be compared between the Raptiva and placebo treated groups before and after the treatment. Patients who either do not tolerate the drug or have worsening in their disease activity will be withdrawn from the protocol.
If Raptiva is well tolerated in this study and the treatment is associated with improvement in clinical parameters of Sjogren's Syndrome, further large studies of efficacy are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Raptiva | Experimental | Drug: RaptivaAt 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 | Placebo comparator | Drug: RaptivaWeekly 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (39 listed)
- Up to 25 patients may be enrolled in this study to obtain at least 20 patients to complete the study and to allow for an estimated up to 20% early attrition rate. Eligible patients will have primary SS diagnosed according to the American-European Consensus Group Sjogren's Syndrome Classification Criteria. Subjects will be chosen based on their potential capacity to reverse the inflammatory process and at least partially recover the exocrine function in the salivary and lacrimal glands, as indicated in the inclusion criteria by requiring a minimal level of salivary flow as a marker of functional gland tissue. Pre-screening, which would include ophthalmologic evaluation, standard laboratory tests, and minor salivary gland biopsy, will be performed under the natural history protocol, and eligible patients will be offered to sign the informed consent for this protocol.
- Age at entry at least 18 years
- Must give written informed consent prior to entry in the protocol.
- Must fulfill at least 4 of the 6 following criteria for Primary SS as defined by the American-European Consensus Group Sjogren's Syndrome Classification Criteria, including either item IV or VI, or fulfill 3 of the 4 objective criteria (III, IV, V, VI) [53] :
- Dry eyes greater than 3 months
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RaptivaAlso: efalizumab, anti-CD11a monoclonal antibodyDuring the first phase of the study, subjects are randomized in a double blind fashion to receive weekly subcutaneous injections of efalizumab (Raptiva) or placebo (weeks 0-12). The second 12 weeks long phase is open label with all subjects receiving weekly subcutaneous injections of efalizumab. | Drug | Raptiva, placebo |
Primary outcome
Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks
Time frame: 3 months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7768059Skopouli FN, Moutsopoulos HM. Autoimmune epitheliitis: Sjogren's syndrome. Clin Exp Rheumatol. 1994 Nov-Dec;12 Suppl 11:S9-11.
- Background: PubMed 8335784Atkinson JC, Fox PC. Sjogren's syndrome: oral and dental considerations. J Am Dent Assoc. 1993 Mar;124(3):74-6, 78-82, 84-6. doi: 10.14219/jada.archive.1993.0064.
- Background: PubMed 12169882Garcia-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. doi: 10.1097/00005792-200207000-00003. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabor G Illei, MD, PhD, MHS principal investigator
National Institute of Dental and Craniofacial Research (NIDCR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Raptiva in people with Sjogren's Syndrome, run by National Institute of Dental and Craniofacial Research (NIDCR) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 39 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Dec 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00344448, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.