Overview

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

Status:
Withdrawn

Trial end date:
2014-10-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Qingping Yao
The Cleveland Clinic

Collaborator:

Bristol-Myers Squibb

Treatments:

Abatacept

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