Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study
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|ClinicalTrials.gov Identifier: NCT02027298|
Recruitment Status : Withdrawn (No Enrollment)
First Posted : January 6, 2014
Last Update Posted : January 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Primary Sjogren's Syndrome Secondary Sjogren's Syndrome Inflammatory Arthritis Rheumatoid Arthritis||Drug: Abatacept||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Abatacept by SC injection of 125 mg weekly for 6 months
by SC injection of 125 mg weekly for 6 months
Other Name: Orencia
- Efficacy of Abatacept in patients with inflammatory arthritis and Sjogren's Syndrome [ Time Frame: 6 months ]To determine the efficacy for inflammatory arthritis of Abatacept in patients with both pSS and sSS. The primary efficacy endpoint for determining the efficacy is the proportion of patients meeting the ACR 20% improvement criteria at month 6.
- Increase or change in autoantibody profile [ Time Frame: Month 3, 6 and 3 month follow up ]A secondary endpoint is to assess autoantibody production as measured by Bioplex2200, including antinuclear antibodies (ANA), anti-ENA (Sm, RNP, SSA, SSB, chromatin, Scl70 and centromere) antibodies, anti-dsDNA antibodies, Complement 3 (C3)/Complement 4 (C4), immunoglobulin (Ig), erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP).
- Explore the potential efficacy of Abatacept in the exocrine glandular function [ Time Frame: Month 1, 3 and 6 ]The last efficacy endpoint is to explore the efficacy of Abatacept in the exocrine glandular function including assessment of xerophthalmia and xerostomia using 0-100 mm visual analog scale (VAS)(29) and functional measurement of salivary gland and lacrimal gland.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02027298
|United States, Ohio|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Qingping Yao, MD, Ph.D||The Cleveland Clinic|