Pilot Study of Raptiva to Treat Sjogren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00344448
• Date of registration: 23/06/2006
• Prospective Registration: No
• Primary sponsor: National Institute of Dental and Craniofacial Research (NIDCR)
• Public title: Pilot Study of Raptiva to Treat Sjogren's Syndrome
• Scientific title: A Randomized, Placebo Controlled, Proof of Concept, Study of Raptiva, a Humanized Anti-CD-11a Monoclonal Antibody, in Patients With Sjogren's Syndrome
• Date of first enrolment: June 2006
• Target sample size: 10
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00344448
• Study type: Interventional
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Gabor G Illei, MD, PhD, MHS
• Affiliation: National Institute of Dental and Craniofacial Research (NIDCR)

Key inclusion & exclusion criteria

- INCLUSION CRITERIA:

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

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

EXCLUSION CRITERIA:

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Intervention(s)

Drug: Raptiva

Primary Outcome(s)

Response Rate at the End of the First (Blinded, Placebo Controlled) Phase at 12 Weeks [Time Frame: 3 months]

Secondary ID(s)

060181

06-D-0181

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/12/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00344448