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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 11 January 2021
Main ID:  NCT03882008
Date of registration: 07/11/2018
Prospective Registration: Yes
Primary sponsor: University of Washington
Public title: A Study to Evaluate Biomarkers to Predict Efficacy of Abatacept in Rheumatoid Arthritis
Scientific title: Phase IV Open-Label Study to Evaluate Biomarkers to Predict the Efficacy of Abatacept in Subjects With Rheumatoid Arthritis
Date of first enrolment: May 23, 2019
Target sample size: 25
Recruitment status: Enrolling by invitation
URL:  https://clinicaltrials.gov/show/NCT03882008
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
United States
Contacts
Name:     Kwanghoon Han, MD
Address: 
Telephone:
Email:
Affiliation:  University of Washington
Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Primary Outcome(s)
American College of Rheumatology (ACR) 20 Response at Week 14 [Time Frame: 14 Weeks]
Secondary Outcome(s)
ACR20 Response at Week 24 [Time Frame: 24 Weeks]
ACR50 Response at Week 24 [Time Frame: Week 24]
ACR70 Response at Week 24 [Time Frame: Week 24]
European League Against Rheumatism (EULAR) good or moderate response at Week 24 [Time Frame: Week 24]
Secondary ID(s)
STUDY00004744
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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