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

NCT03882008 | Completed Phase 4 Results FDA Drug

• 1 other identifier: STUDY00004744
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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)

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With 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

  14 Weeks

Secondary Outcomes (4)

• Number of Participants With American College of Rheumatology (ACR) 20 Response at Week 24

  24 Weeks

• Number of Participants With American College of Rheumatology (ACR) 50 Response at Week 24

  Week 24

• Number of Participants With American College of Rheumatology (ACR) 70 Response at Week 24

  Week 24

• Number of Participants With European League Against Rheumatism (EULAR) Good or Moderate Response at Week 24

  Week 24

Study Arms (1)

Abatacept

EXPERIMENTAL

Abatacept 125mg subcutaneous injection weekly for 24 weeks

Drug: Abatacept

Interventions

Abatacept DRUG

All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks

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:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Washington: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Bobby Kwanghoon Han
• Organization: University of Washington

hank4@uw.edu

206-685-9950

Study Officials

• Kwanghoon Han, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, School of Medicine: Department of Medicine: Rheumatology

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: March 20, 2019
• Study Start: May 23, 2019
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 30, 2024
• Results First Posted: July 30, 2024

Record last verified: 2024-07

Locations

US (1)