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Rheumatoid Arthritis Memory B Cells and Abatacept

NCT03652961 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2024-07-03

Study results available
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Summary

Single-Open Label Study to Assess Changes in the Immune Profile in Response to Treatment with Intravenous Abatacept Adults with Rheumatoid Arthritis who are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Conditions

Interventions

DRUG

Abatacept

Abatacept for reconstitution and dilution prior to intravenous (IV) administration. Each single-use vial of Abatacept for injection provides 250-mg Abatacept, maltose (500 mg), monobasic sodium phosphate (17.2 mg), and sodium chloride (14.6 mg) for administration.

DRUG

DMARDs

Patients will receive methotrexate or remain on pre-existing conventional synthetic disease-modifying anti-rheumatic drug (DMARD) if already prescribed.

Sponsors & Collaborators

Principal Investigators

  • Gregg Silverman, MD · NYU Langone Health

  • William Rigby, MD · Dartmouth-Hitchcock Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-02
Primary Completion
2021-09-27
Completion
2021-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03652961 on ClinicalTrials.gov