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Abatacept for SLE Arthritis (IM101-330)

NCT02429934 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2021-05-13

Study results available
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Summary

This research trial is for patients who have been diagnosed with systemic lupus erythematosus (SLE) with swollen, tender joints (which is called inflammatory polyarthritis) because of the SLE.

The purpose of this clinical research study is to evaluate the safety and effectiveness of treatment with abatacept (Abatacept) 125mg injected subcutaneously (under the skin) weekly for 16 weeks versus placebo injections(a substance with no active ingredients and therefore may have no treatment benefit) in subjects with SLE and inflammatory polyarthritis. The effectiveness will be assessed primarily by the number of swollen, tender joints (called a joint count) at each of study visits.

Study Medication Abatacept is approved in the U.S. for treating rheumatoid arthritis by prescription and has not been approved by the U.S. Food and Drug Administration for treating SLE yet.

In this study, subjects will receive treatment with either abatacept or placebo once a week for 16 weeks (a total of 16 injections).

Conditions

  • Systemic Lupus Erythematosus Arthritis

Interventions

BIOLOGICAL

abatacept also known as Orencia also known as CTLA4-Ig

125mg injected subcutaneously weekly for 16 weeks

DRUG

Placebo

Sponsors & Collaborators

Principal Investigators

  • Bevra Hahn, M.D. · University of California, Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT02429934 on ClinicalTrials.gov