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

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ClinicalTrials.gov Identifier: NCT03882008
Recruitment Status : Enrolling by invitation
First Posted : March 20, 2019
Last Update Posted : April 18, 2019
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Kwanghoon (Bobby) Han, University of Washington

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)

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Abatacept Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis
Estimated Study Start Date : April 25, 2019
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Experimental: Abatacept
Abatacept 125mg subcutaneous injection weekly for 24 weeks
Drug: Abatacept
All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks
Other Name: Orencia




Primary Outcome Measures :
  1. American College of Rheumatology (ACR) 20 Response at Week 14 [ Time Frame: 14 Weeks ]
    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 :
  1. ACR20 Response at Week 24 [ Time Frame: 24 Weeks ]
    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

  2. ACR50 Response at Week 24 [ Time Frame: 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

  3. ACR70 Response at Week 24 [ Time Frame: 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

  4. European League Against Rheumatism (EULAR) good or moderate response at Week 24 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

    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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882008


Locations
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United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Bristol-Myers Squibb
Investigators
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Principal Investigator: Kwanghoon Han, MD University of Washington

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Responsible Party: Kwanghoon (Bobby) Han, Assistant Professor, School of Medicine: Department of Medicine: Rheumatology, University of Washington
ClinicalTrials.gov Identifier: NCT03882008     History of Changes
Other Study ID Numbers: STUDY00004744
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Connective Tissue Diseases
Abatacept
Immunosuppressive Agents
Physiological Effects of Drugs
Antirheumatic Agents
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors