NCT02027298

Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary purpose of this pilot study is to evaluate the efficacy and safety of Abatacept in subjects with Sjogren's Syndrome (SS). This clinical trial study will enroll and treat 15 subjects with active moderate and severe inflammatory arthritis associated with primary Sjogren's syndrome (pSS) and secondary Sjogren's sybdrine (sSS) with Rheumatoid Arthrits (RA). All subjects will receive Abatacept weekly by Subcutaneous (SC) dosing. Subjects will receive Abatacept by SC injection of 125 mg on day 1 and followed by 125 mg SC weekly thereafter.

Detailed description

Sjogren's Syndrome (SS) is a common systemic autoimmune disease, including primary and secondary form. About 30% of RA are associated with sSS (1) Tumor necrosis factor alpha inhibitors (TNFa-Is) have been tried in this population without success. Abatacept (CTLA4-Ig) is comprised of the ligand-binding domain of CTLA4 plus human immunoglobulin and represents a novel therapeutic costimulation blocker that modulates the signal required for full T cell activation. Studies have shown that activated CD4 T cells play a role in the pathogenesis of SS, indicating Abatacept might be a useful therapeutic intervention in SS. Subjects who are receiving non-biologic immunosuppressive medications consisting of hydroxychloroquine, methotrexate (MTX), sulfasalazine, or leflunomide, at the time of enrollment will remain on these medications without dosage alteration. Efficacy and Safety data will be collected at the time of each clinic visit. The treatment closing date will occur 6 months after enrollment of each subject. Subjects will be followed at 1, 2, 3, 4, 5, and 6 months. Laboratory studies associated with the clinical trial will test potential autoantibody production for systemic autoimmune diseases.

Conditions

• Primary Sjogren's Syndrome
• Secondary Sjogren's Syndrome
• Inflammatory Arthritis
• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Abatacept	by SC injection of 125 mg weekly for 6 months

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-01-06
• Last updated: 2017-01-09

Locations

1 site across 1 country: United States