Topics

Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome

2019-09-23 04:51:40 | BioPortfolio

Summary

This pilot study will make a preliminary determination of the safety of ustekinumab in patients with Primary Sjogren's Syndrome (PSS) and assess the response of systemic measures of inflammation (biomarkers).

Description

This is a single-center, open label, pilot trial of ustekinumab in patients with Primary Sjögren's Syndrome (PSS). Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.

Study Design

Conditions

Primary Sjögren Syndrome

Intervention

Ustekinumab

Status

Not yet recruiting

Source

University of Rochester

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-23T04:51:40-0400

Clinical Trials [1208 Associated Clinical Trials listed on BioPortfolio]

PATIENT-REPORTED OUTCOMES AND OBJECTIVE EYE DRYNESS EVALUATION IN PRIMARY SJÖGREN'S SYNDROME

The objective of this observational study is to develop new tools to assess primary Sjögren's syndrome (pSS) symptoms and to measure the severity of eye involvement in these patients.

A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome

The purpose of this study is to initially observe the safety and effectivity of RC18 in Participants with Primary Sjögren's Syndrome.

Safety, Pharmacokinetics and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta inhibitor, for ...

Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome

This Study is designed to evaluate the safety, tolerability, pharmacokinetics and preliminary therapeutic efficacy of oral administrations of CDZ173, a selective PI3K Delta inhibitor, for ...

Lacripep™ in Subjects With Dry Eye Associated With Primary Sjögren's Syndrome

The objective of this study is to evaluate the efficacy and safety of two strengths of Lacripep™ ophthalmic solution versus placebo administered three times daily for four weeks in subje...

PubMed Articles [10525 Associated PubMed Articles listed on BioPortfolio]

Primary Sjögren's syndrome and the eye.

Primary Sjögren syndrome is an autoimmune disease that mainly affects exocrine glands such as the salivary and lacrimal glands. In addition, systemic involvement is common. Primary Sjögren syndrome ...

Anti-RNP positivity in primary Sjögren's syndrome is associated with a more active disease and a more frequent muscular and pulmonary involvement.

To describe and compare the clinical and biological characteristics of subjects with primary Sjögren's syndrome (pSS) with and without anti-RNP antibodies.

Distinct clinical characteristics of anti-Ro/SSA-negative primary Sjögren's syndrome: data from a nationwide cohort for Sjögren's syndrome in Korea.

To investigate clinical characteristics of patients with primary Sjögren's syndrome (SS) who were negative for anti-Ro/SSA antibody but positive for minor salivary gland biopsy (MSGB) compared to pat...

A two-phase cohort study of the sleep phenotype within primary Sjögren's syndrome and its clinical correlates.

To characterise the sleep profile of patients with primary Sjögren's syndrome (pSS) and its relationship between hyper-somnolence and other clinical parameters.

Prognostic markers of lymphoma development in primary Sjögren syndrome.

Sjögren syndrome is a systemic autoimmune disease that principally affects women between the fourth and sixth decades of life who present with sicca symptomatology caused by dryness of the main mucos...

Medical and Biotech [MESH] Definitions

A humanized monoclonal antibody that binds to IL-12 and IL-23 and is used as a DERMATOLOGIC AGENT in the treatment of patients with plaque PSORIASIS who have not responded to other therapies.

Primary immunodeficiency syndrome characterized by recurrent infections and hyperimmunoglobulinemia E. Most cases are sporadic. Of the rare familial forms, the dominantly inherited subtype has additional connective tissue, dental and skeletal involvement that the recessive type does not share.

A primary headache disorder that is characterized by frequent short-lasting, unilateral, neuralgiform pain attacks in the ocular area, with CONJUNCTIVA fluid-filling and tearing. SUNCT syndrome is usually resistant to treatment.

Acute respiratory illness in humans caused by the Muerto Canyon virus whose primary rodent reservoir is the deer mouse Peromyscus maniculatus. First identified in the southwestern United States, this syndrome is characterized most commonly by fever, myalgias, headache, cough, and rapid respiratory failure.

A condition caused by occlusion of terminal aorta, the primary branches of the ABDOMINAL AORTA, as in aortoiliac obstruction. Leriche syndrome usually occurs in males and is characterized by IMPOTENCE, absence of a pulse in the femoral arteries, weakness and numbness in the lower back, buttocks, hips, and lower limbs.

More From BioPortfolio on "Pilot Trial of Ustekinumab for Primary Sjögren's Syndrome"

Quick Search

Searches Linking to this Trial