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

Status unconfirmed · Phase 4

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT02270970

Run by

Oklahoma Medical Research Foundation

People needed

20

Starts

2014-10-01

Expected to finish

2019-12-01

Last updated by the study team

2017-12-07

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States (enrolling)

Full record on ClinicalTrials.gov

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