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

NCT02027298 | Withdrawn Phase 2

• 1 other identifier: CC-Yao-2012001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Abatacept; Sjogren's Syndrome; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• Increase or change in autoantibody profile

  Month 3, 6 and 3 month follow up

• Explore the potential efficacy of Abatacept in the exocrine glandular function

  Month 1, 3 and 6

Study Arms (1)

Abatacept

EXPERIMENTAL

Abatacept by SC injection of 125 mg weekly for 6 months

Drug: Abatacept

Interventions

Abatacept DRUG

by SC injection of 125 mg weekly for 6 months

Also known as: Orencia

Abatacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Arthritis; Arthritis, Rheumatoid; Sjogren's Syndrome

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Qingping Yao, MD, Ph.D

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: January 6, 2014
• Study Start: November 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 9, 2017

Record last verified: 2015-02

Locations

US (1)