Clinical Trials Logo
  1. Home
  2. Primary Sjögren's Syndrome
  3. NCT01552681

Baminercept, a Lymphotoxin-Beta Receptor Fusion Protein, for Treatment of Sjögren's Syndrome

Primary Sjögren's Syndrome Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial of Baminercept, a Lymphotoxin-beta Receptor Fusion Protein, for the Treatment of Primary Sjögren's Syndrome (ASJ02)

Clinical Trial Summary

The purpose of the study is to find out if the experimental study agent, baminercept, is effective in treating patients with Sjögren's syndrome. The study will also determine if the study agent can be safely given to patients with Sjögren's syndrome; examine how it affects symptoms of the disease; and attempt to understand how baminercept affects the underlying mechanisms of Sjögren's syndrome and the immune system.

Clinical Trial Description

Sjögren's syndrome is an autoimmune disorder in which a person's own immune cells attack the body's tear and salivary glands. This disease is the second most common autoimmune disorder, affects close to four million people in the U.S., and has no known cause. About one-third of patients with Sjögren's syndrome have enlarged parotid glands (the largest salivary glands, the glands that make saliva); inflammation of organs such as the lungs and joints may also occur. There is no known effective treatment other than measures that can relieve symptoms. One of the most bothersome symptoms is dryness of the eyes and mouth. Eye drops and saliva stimulants (which help make more saliva) are common treatments. When other organs are affected, symptoms are treated with corticosteroids (prednisone), non-steroidal anti-inflammatory drugs (NSAIDs, such as ibuprofen and naproxen), hydroxychloroquine (Plaquenil®) or other medications that suppress the immune system. These drugs may curb or kill cells of the immune system, but they are not always helpful, do not cure Sjögren's syndrome, and can have many side effects. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01552681
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 2
Start date July 2012
Completion date June 2015
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT03040583 - The ASSESS National Multi-center Prospective Cohort
Completed NCT01989819 - Primary Sjögren Syndrome
Completed NCT02291029 - Safety, Pharmacokinetics and Preliminary Efficacy Study of CFZ533 in Patients With Primary Sjögren's Syndrome Phase 2
Terminated NCT02610543 - UCB Proof of Concept Study in Patients With Primary Sjögren's Syndrome Phase 2
Not yet recruiting NCT04975087 - The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory
Completed NCT04078386 - A Study of TACI-antibody Fusion Protein Injection (RC18) in Subjects With Primary Sjögren's Syndrome Phase 2
Recruiting NCT05087589 - Efficacy, Safety and Immunological Evaluation of Tofacitinib in the Treatment of Primary Sjogren's Syndrome Phase 2
Recruiting NCT04212572 - Ultrasound Abnormalities of the Salivary Glands in Primary Sjögren's Syndrome According to the Duration of the Disease
Completed NCT02149420 - PD of VAY736 in Patients With Primary Sjögren's Syndrome Phase 2
Recruiting NCT04858464 - Reliability, Validity of the Turkish Version of the Primary Sjögren Syndrome Quality of Life (PSS-QoL) Questionnaire
Recruiting NCT03003572 - Autoreactive Anti-Ro/SSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity
Completed NCT00632866 - Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome Phase 3
Completed NCT02334306 - A Phase 2a, Randomized, Placebo Controlled, Study to Evaluate the Safety and Efficacy of AMG 557/MEDI5872 in Primary Sjögren's Syndrome Phase 2
Completed NCT02775916 - Safety, Pharmacokinetics, and Preliminary Efficacy Study of CDZ173 in Patients With Primary Sjögren's Syndrome Phase 2
Completed NCT02464319 - A Phase II Study With Low-dose Recombinant Human IL-2 for the Treatment of Primary Sjögren's Syndrome Phase 2
Completed NCT04186871 - Study to Assess Safety and Effectiveness of Branebrutinib Treatment in Participants With Active Systemic Lupus Erythematosus or Primary Sjögren's Syndrome, or Branebrutinib Treatment Followed by Open-label Abatacept Treatment in Study Participants With Active Rheumatoid Arthritis Phase 2
Completed NCT00426543 - Effect of B-cell Depletion in Patients With Primary Sjögren's Syndrome Phase 2
Recruiting NCT04981145 - The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome Phase 4
Completed NCT06432101 - Acupuncture Combined With Hydroxychloroquine N/A
Completed NCT03627065 - A Study of INCB050465 in Primary Sjögren's Syndrome Phase 2