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

Study Purpose

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)

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03882008
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Washington
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kwanghoon Han, MD
Principal Investigator Affiliation University of Washington
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Arms & Interventions

Arms

Experimental: Abatacept

Abatacept 125mg subcutaneous injection weekly for 24 weeks

Interventions

Drug: - Abatacept

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Washington, Seattle, Washington

Status

Address

University of Washington

Seattle, Washington, 98195