Status:
UNKNOWN
Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
16-70 years
Phase:
PHASE4
Brief 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 regime...
Detailed Description
Primary Objective: This study will determine clinical response to belimumab using the SRI 4 (SLE Responder Index) which was used in the Phase III belimumab trials which led to its approval by the FDA....
Eligibility Criteria
Inclusion
- Patients who meet 1987 ACR criteria for SLE with 1996 modifications
- SLEDAI \>/= 6 at screening visit
- Positive ANA OR anti-dsDNA within one year of screening
- In the opinion of the investigator there is intent to treat with a biologic (e.g. patient failed standard of care treatment) however there is no organ threatening disease
Exclusion
- Hg less than 8.0 or hemolytic anemia
- Lymphocyte count less than 0.4
- AST/ALT greater than 2.5 times ULN
- Infection requiring IV antibiotics within a month of screening or oral antibiotics within two weeks of first dose
- Active chronic infections (such as tuberculosis) which have not been treated or tb exposure in a person under 40 who has not received suppressive therapy for at least 3 months. Herpes zoster outbreak within three months of dosing. (Suppressive therapy for herpes simplex is not an exclusion criterion).
- Cancer within 5 years (except for completely excised cervical carcinoma in situ or excised non-melanoma skin cancer)
- Inability or unwillingness to follow the protocol
- If WOCBP, inability or unwillingness to practice an acceptable method of contraception (including abstinence, barrier method with spermicide, or hormonal treatment
- Inability or unwillingness to withdraw from hydroxychloroquine and/or any immune suppressive therapy being taken despite option for immediate steroid treatment and later treatment rescues as needed.
- Any illness or condition that, in the opinion of the investigator, would cause undue hardship or risk to the subject by participating in the protocol
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Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02270970
Start Date
October 1 2014
End Date
December 1 2019
Last Update
December 7 2017
Active Locations (1)
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1
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104