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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02027298
• Date of registration: 18/11/2013
• Prospective Registration: No
• Primary sponsor: The Cleveland Clinic
• Public title: Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study
• Scientific title: Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study
• Date of first enrolment: November 2013
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT02027298
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Qingping Yao, MD, Ph.D
• Affiliation: The Cleveland Clinic

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of Sjogren's Syndrome

2. Patients are at least 18 years or older

3. Patients should have either pSS and/or sSS associated with RA, and must have active
moderate to severe inflammatory arthritis as defined by painful joint counts (=5) and
swollen joint counts (=5), or DAS28 scores>3.2.

4. One non-biologic DMARD will be permitted.

5. These patients will be willing and able to comply with treatment and follow-up
procedures.

6. These patients will be willing and able to provide written informed consent.

7. Both women and men of child bearing age must be willing to use an effective means of
birth control while receiving treatment throughout participation in this study.
Effective contraception methods include abstinence, oral contraceptives (birth control
pills), IUD, diaphragm, Norplant, approved hormone injections, condoms, or medical
sterilization.

Exclusion Criteria:

1. Patients will be excluded if they have a concomitant disorder requiring systemic
glucocorticoid (GC) therapy (prednisone >10 mg daily or GC equivalent), have
organ-threatening features, and have any investigational drug including biologics
within 28 days of study entry.

2. History of cancer or diabetes mellitus

3. Use of tricyclic antidepressants or anticholinergics

4. Evidence of active infection or chronic infection including human immunodeficiency
virus (HIV), tuberculosis (TB), hepatitis C, or a positive hepatitis B surface
antigen.

5. Patients with latent TB if not treated with isoniazid for at least 4 weeks prior to
receiving the study drug

6. Radiographic evidence of COPD, emphysema, and/or interstitial lung disease.

7. Subjects who are pregnant or who are nursing infants

8. Patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil
count<1500/mm3, hematocrit < 20%.

9. Patients with renal insufficiency defined by a serum creatinine of greater than or
equal to 2.0 mg/dL or creatinine clearance of less than or equal to 35 ml/min.

10. Use of illegal drugs.

11. A live vaccination fewer than 4 weeks before enrollment



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sjogren's Syndrome

Rheumatoid Arthritis

Secondary Sjogren's Syndrome

Inflammatory Arthritis

Intervention(s)

Drug: Abatacept

Primary Outcome(s)

Efficacy of Abatacept in patients with inflammatory arthritis and Sjogren's Syndrome [Time Frame: 6 months]

Secondary Outcome(s)

Explore the potential efficacy of Abatacept in the exocrine glandular function [Time Frame: Month 1, 3 and 6]

Increase or change in autoantibody profile [Time Frame: Month 3, 6 and 3 month follow up]

Secondary ID(s)

CC-Yao-2012001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Bristol-Myers Squibb