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Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy

NCT02270970 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-07

No results posted yet for this study

Summary

This will be an open label, non-randomized trial of belimumab in at least 20 subjects to test the feasibility of belimumab as a single agent and to capitalize on simplified background treatment regimens to determine immunologic differences between patients who do versus do not meet clinical response criteria.

Conditions

Interventions

BIOLOGICAL

belimumab

belimumab will be given at 10 mg/kg intravenously at Week 1, Week 2, Week 4 and monthly after that as was done in Phase III trials and approved in the FDA label

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Oklahoma Medical Research Foundation

    lead OTHER

Principal Investigators

  • Katherine Thanou, M.D. · Oklahoma Medical Research Foundation

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-12-31
Completion
2019-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT02270970 on ClinicalTrials.gov