Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study
Abatacept for Patients With Inflammatory Arthritis Associated With Sjögren's Syndrome: an Open-Label Phase II Study
Sponsors
Source
The Cleveland Clinic
Oversight Info
Has Dmc
No
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.
Overall Status
Withdrawn
Start Date
2013-11-01
Completion Date
2014-10-01
Primary Completion Date
2014-10-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Efficacy of Abatacept in patients with inflammatory arthritis and Sjogren's Syndrome |
6 months |
Secondary Outcome
Measure |
Time Frame |
|
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 |
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
by SC injection of 125 mg weekly for 6 months
Arm Group Label
Abatacept
Other Name
Orencia
Eligibility
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
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Qingping Yao, MD, Ph.D |
Principal Investigator |
The Cleveland Clinic |
Location
Facility |
|
Cleveland Clinic Cleveland Ohio 44195 United States |
Location Countries
Country
United States
Verification Date
2015-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Intervention Browse
Mesh Term
Abatacept
Arm Group
Arm Group Label
Abatacept
Arm Group Type
Experimental
Description
Abatacept by SC injection of 125 mg weekly for 6 months
Firstreceived Results Date
N/A
Why Stopped
No Enrollment
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
November 18, 2013
Study First Submitted Qc
January 2, 2014
Study First Posted
January 6, 2014
Last Update Submitted
January 5, 2017
Last Update Submitted Qc
January 5, 2017
Last Update Posted
January 9, 2017
ClinicalTrials.gov processed this data on December 09, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.