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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 December 2023
• 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: Completed
• URL: https://clinicaltrials.gov/ct2/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
• 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)

ACR50 Response at Week 24 [Time Frame: Week 24]

ACR20 Response at Week 24 [Time Frame: 24 Weeks]

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