A Phase II study of Rituxmab for the treatment of Sjogrens Syndrome

A Phase II study to evaluate the safety and histological response to Rituximab in adults with Sjogren's Syndrome

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000396628

Enrollment

Registered

2005-09-14

Start date

2005-06-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Open label, non-randomised, phase II, 48 week study of rituximab in subjects with Sjogrens Syndrome.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Sjogrens Syndrome according torecently updated European-American criteria, 2. Unchanged Sjogrens Syndrome for atleast 3 months 3. no aspirin or NSAID therapy within 7 days of each parotid or labial biopsy.

Exclusion criteria

1. radiation-induced xerostomia2. prior salivary gland surgery3. known parotid duct obstruction4. anticholinergic and sympathomimetic therapy5. prior rituxmab therapylive vaccine within 4 week of therapy6. history of cancer, recurrent bacterial infections or immunodeficiency7.pregnacy or brest feeding8. lab abnormality at screening7.

Outcome results