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Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background

NCT02053727 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2020-11-16

No results posted yet for this study

Summary

The purpose of this study is to investigate whether the combination of abatacept along with entecavir (the study drugs) is safe and effective in treating symptoms related to rheumatoid arthritis (RA).

Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form, is approved by the FDA for the treatment of RA. In this research, abatacept will be given by injection. A subcutaneous injection is an injection given under the skin.

Entecavir, to be taken by mouth, is approved by the FDA for the treatment of hepatitis B.

The study is divided into the following time periods:

Screening Phase: Up to 4 weeks Randomized Double-blind Phase: 24 weeks Open-label Extension Phase: 24 weeksFollow-up Phase: a phone call after Week 48

Each phase contains one or more study visits.

Conditions

Interventions

DRUG

Abatacept

Abatacept Injection, 125 mg/Syringe (125 mg/mL), is a sterile solution for SC administration, which contains approximately 126 mg abatacept.

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Suzanne Kafaja, M.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2018-06-12
Completion
2018-06-12

Countries

  • United States

Study Locations

More Related Trials

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 NCT02053727 on ClinicalTrials.gov