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

Primary Purpose

Primary Sjogren's Syndrome, Secondary Sjogren's Syndrome, Inflammatory Arthritis

Status

Withdrawn

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Abatacept

About this trial

This is an interventional treatment trial for Primary Sjogren's Syndrome focused on measuring Abatacept, Sjogren's Syndrome, Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosis of Sjogren's Syndrome
Patients are at least 18 years or older
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.
One non-biologic DMARD will be permitted.
These patients will be willing and able to comply with treatment and follow-up procedures.
These patients will be willing and able to provide written informed consent.
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:

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.
History of cancer or diabetes mellitus
Use of tricyclic antidepressants or anticholinergics
Evidence of active infection or chronic infection including human immunodeficiency virus (HIV), tuberculosis (TB), hepatitis C, or a positive hepatitis B surface antigen.
Patients with latent TB if not treated with isoniazid for at least 4 weeks prior to receiving the study drug
Radiographic evidence of COPD, emphysema, and/or interstitial lung disease.
Subjects who are pregnant or who are nursing infants
Patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil count<1500/mm3, hematocrit < 20%.
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.
Use of illegal drugs.
A live vaccination fewer than 4 weeks before enrollment

Sites / Locations

Cleveland Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abatacept

Arm Description

Abatacept by SC injection of 125 mg weekly for 6 months

Outcomes

Primary Outcome Measures

Efficacy of Abatacept in patients with inflammatory arthritis and Sjogren's Syndrome

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.

Secondary Outcome Measures

Increase or change in autoantibody profile

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

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.

Full Information

NCT ID

NCT02027298

First Posted

November 18, 2013

Last Updated

January 5, 2017

Sponsor

The Cleveland Clinic

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT02027298

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Withdrawn

Why Stopped

No Enrollment

Study Start Date

November 2013 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Abatacept, Sjogren's Syndrome, Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Abatacept

Arm Type

Experimental

Arm Description

Abatacept by SC injection of 125 mg weekly for 6 months

Intervention Type

Drug

Intervention Name(s)

Abatacept

Other Intervention Name(s)

Orencia

Intervention Description

by SC injection of 125 mg weekly for 6 months

Primary Outcome Measure Information:

Title

Efficacy of Abatacept in patients with inflammatory arthritis and Sjogren's Syndrome

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Increase or change in autoantibody profile

Description

Time Frame

Month 3, 6 and 3 month follow up

Title

Explore the potential efficacy of Abatacept in the exocrine glandular function

Description

Time Frame

Month 1, 3 and 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Diagnosis of Sjogren's Syndrome Patients are at least 18 years or older 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. One non-biologic DMARD will be permitted. These patients will be willing and able to comply with treatment and follow-up procedures. These patients will be willing and able to provide written informed consent. 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: 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. History of cancer or diabetes mellitus Use of tricyclic antidepressants or anticholinergics Evidence of active infection or chronic infection including human immunodeficiency virus (HIV), tuberculosis (TB), hepatitis C, or a positive hepatitis B surface antigen. Patients with latent TB if not treated with isoniazid for at least 4 weeks prior to receiving the study drug Radiographic evidence of COPD, emphysema, and/or interstitial lung disease. Subjects who are pregnant or who are nursing infants Patients with cytopenia: platelet count <80,000/mm3, absolute neutrophil count<1500/mm3, hematocrit < 20%. 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. Use of illegal drugs. A live vaccination fewer than 4 weeks before enrollment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qingping Yao, MD, Ph.D

Organizational Affiliation

The Cleveland Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cleveland Clinic

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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