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A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Abatacept
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Rheumatoid Arthritis

Eligibility Criteria

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

Inclusion Criteria:

  • Male or non-pregnant, non-nursing female
  • Age 18 years or greater
  • Body weight less than or equal to 120 kg
  • Classification of Rheumatoid Arthritis according to the 1987 ACR criteria or 2010 ACR/EULAR criteria
  • Symptoms of Rheumatoid Arthritis present for at least 3 months and less that 10 years prior to Screening.
  • Clinical Disease Activity Index (CDAI) greater than or equal to 16, corresponding to moderate to severe disease activity.
  • Patients taking oral DMARDs must be on stable doses of DMARDs for at least 4 weeks prior to Abatacept initiation
  • Treatment within the past year with either methotrexate, leflunomide, hydroxychloroquine and/or sulfasalazine for greater than or equal to 8 weeks.
  • Patients who have received one prior Tumor necrosis factor (TNF) inhibitor must have discontinued etanercept, infliximab, adalimumab, certolizumab, or golimumab for at least 6 months prior to screening.
  • Patients taking oral corticosteroids, the dose must be less than or equal to 5mg per day (prednisone or equivalent)
  • Females of child bearing potential and males with female partners of child bearing potential may participate in this study only if using a reliable means of contraception

Exclusion Criteria:

  • Previous treatment with Abatacept (Orencia)
  • Previous treatment with rituximab, tocilizumab, tofacitinib, sarilumab, or anakinra
  • Previous treatment with IV immunoglobulin, plasmapheresis, or alkylating agents such as cyclophosphamide
  • Intraarticular or parenteral corticosteroids within 4 weeks of screening
  • Rheumatic autoimmune disease other than Rheumatoid Arthritis, including Systemic Lupus Erythematosus, primary Sjogren syndrome, spondyloarthritis, systemic sclerosis, dermatomyositis, mixed connective tissue disease, or vasculitis
  • Non-rheumatic auto-immune disease including inflammatory bowel disease, psoriasis, multiple sclerosis
  • Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, latent tuberculosis (TB) (TB not adequately treated)
  • Primary or secondary immunodeficiency
  • Current, uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease
  • History of malignancy within 10 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma
  • History of alcohol, drug, or chemical abuse within 1 year prior to screening

  • Laboratory exclusion criteria at screening including:

    1. estimated glomerular filtration rate (eGFR) <30ml/min
    2. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >1.5 times upper limit of normal
  • Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study
  • Immunization with a live/attenuated vaccine within 4 weeks prior to screening
  • Pregnant or nursing women, or women of child bearing potential who plan to become pregnant prior to 14 weeks after the last dose of abatacept treatment
  • Patients of reproductive potential not willing to use an effective method of contraception
  • Prisoners, or subjects who are compulsory detained

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Abatacept

Arm Description

Abatacept 125mg subcutaneous injection weekly for 24 weeks

Outcomes

Primary Outcome Measures

American College of Rheumatology (ACR) 20 Response at Week 14
Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept

Secondary Outcome Measures

ACR20 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
ACR50 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
ACR70 Response at Week 24
Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
European League Against Rheumatism (EULAR) good or moderate response at Week 24
Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept

Full Information

First Posted
November 7, 2018
Last Updated
December 3, 2020
Sponsor
University of Washington
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03882008
Brief Title
A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis
Official Title
Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary objective of this study is to evaluate if baseline levels of T cell associated biomarkers predict efficacy of abatacept during 24 weeks of treatment in patients with moderate to severe active Rheumatoid Arthritis (RA) who have had an inadequate response to conventional disease modifying anti-rheumatic drugs (cDMARDs)

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Abatacept
Arm Type
Experimental
Arm Description
Abatacept 125mg subcutaneous injection weekly for 24 weeks
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks
Primary Outcome Measure Information:
Title
American College of Rheumatology (ACR) 20 Response at Week 14
Description
Baseline levels of T cell-associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time Frame
14 Weeks
Secondary Outcome Measure Information:
Title
ACR20 Response at Week 24
Description
Baseline levels of T cell associated biomarkers predict ACR20 response (improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time Frame
24 Weeks
Title
ACR50 Response at Week 24
Description
Baseline levels of T cell associated biomarkers predict ACR50 response (improvement of 50% in the number of tender and number of swollen joints, and a 50% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time Frame
Week 24
Title
ACR70 Response at Week 24
Description
Baseline levels of T cell associated biomarkers predict ACR70 response (improvement of 70% in the number of tender and number of swollen joints, and a 70% improvement in three of the following five criteria: patient global assessment, physician global assessment, pain, functional ability measure, erythrocyte sedimentation rate (ESR) or C-reactive protein) with subcutaneous abatacept
Time Frame
Week 24
Title
European League Against Rheumatism (EULAR) good or moderate response at Week 24
Description
Baseline levels of T cell associated biomarkers predict EULAR good or moderate response (disease activity index for RA generated from tender and swollen joint count, patient global assessment, ESR or C-reactive protein) with subcutaneous abatacept
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or non-pregnant, non-nursing female Age 18 years or greater Body weight less than or equal to 120 kg Classification of Rheumatoid Arthritis according to the 1987 ACR criteria or 2010 ACR/EULAR criteria Symptoms of Rheumatoid Arthritis present for at least 3 months and less that 10 years prior to Screening. Clinical Disease Activity Index (CDAI) greater than or equal to 16, corresponding to moderate to severe disease activity. Patients taking oral DMARDs must be on stable doses of DMARDs for at least 4 weeks prior to Abatacept initiation Treatment within the past year with either methotrexate, leflunomide, hydroxychloroquine and/or sulfasalazine for greater than or equal to 8 weeks. Patients who have received one prior Tumor necrosis factor (TNF) inhibitor must have discontinued etanercept, infliximab, adalimumab, certolizumab, or golimumab for at least 6 months prior to screening. Patients taking oral corticosteroids, the dose must be less than or equal to 5mg per day (prednisone or equivalent) Females of child bearing potential and males with female partners of child bearing potential may participate in this study only if using a reliable means of contraception Exclusion Criteria: Previous treatment with Abatacept (Orencia) Previous treatment with rituximab, tocilizumab, tofacitinib, sarilumab, or anakinra Previous treatment with IV immunoglobulin, plasmapheresis, or alkylating agents such as cyclophosphamide Intraarticular or parenteral corticosteroids within 4 weeks of screening Rheumatic autoimmune disease other than Rheumatoid Arthritis, including Systemic Lupus Erythematosus, primary Sjogren syndrome, spondyloarthritis, systemic sclerosis, dermatomyositis, mixed connective tissue disease, or vasculitis Non-rheumatic auto-immune disease including inflammatory bowel disease, psoriasis, multiple sclerosis Recurrent or chronic bacterial, viral, fungal, mycobacterial, or other infections including Human immunodeficiency virus (HIV), Hepatitis B, Hepatitis C, latent tuberculosis (TB) (TB not adequately treated) Primary or secondary immunodeficiency Current, uncontrolled renal, gastrointestinal, endocrine, pulmonary, cardiac, or neurologic disease History of malignancy within 10 years prior to screening, except for appropriately treated carcinoma in situ of the cervix or non-melanoma skin carcinoma History of alcohol, drug, or chemical abuse within 1 year prior to screening Laboratory exclusion criteria at screening including: estimated glomerular filtration rate (eGFR) <30ml/min Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) >1.5 times upper limit of normal Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery during the study Immunization with a live/attenuated vaccine within 4 weeks prior to screening Pregnant or nursing women, or women of child bearing potential who plan to become pregnant prior to 14 weeks after the last dose of abatacept treatment Patients of reproductive potential not willing to use an effective method of contraception Prisoners, or subjects who are compulsory detained
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kwanghoon Han, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States

12. IPD Sharing Statement

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A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis

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