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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02270970
• Date of registration: 13/10/2014
• Prospective Registration: No
• Primary sponsor: Oklahoma Medical Research Foundation
• Public title: Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy BLAST
• Scientific title: Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
• Date of first enrolment: October 2014
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02270970
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Katherine Thanou, M.D.
• Affiliation: Oklahoma Medical Research Foundation

• Name: Joan T Merrill, MD

• Name: Joan T Merrill, M.D.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients who meet 1987 ACR criteria for SLE with 1996 modifications

2. SLEDAI >/= 6 at screening visit

3. Positive ANA OR anti-dsDNA within one year of screening

4. 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 Criteria:

1. Hg less than 8.0 or hemolytic anemia

2. Lymphocyte count less than 0.4

3. AST/ALT greater than 2.5 times ULN

4. Infection requiring IV antibiotics within a month of screening or oral antibiotics
within two weeks of first dose

5. 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).

6. Cancer within 5 years (except for completely excised cervical carcinoma in situ or
excised non-melanoma skin cancer)

7. Inability or unwillingness to follow the protocol

8. If WOCBP, inability or unwillingness to practice an acceptable method of contraception
(including abstinence, barrier method with spermicide, or hormonal treatment

9. 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.

10. 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



Age minimum: 16 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Systemic Lupus Erythematosus

Intervention(s)

Biological: belimumab

Primary Outcome(s)

BLAST-50 response rate in clinical responders vs non responders [Time Frame: 3 months]

Secondary Outcome(s)

BICLA response rates compared to historical controls from the BOLD study [Time Frame: 6 months]

LFA-REAL at baseline and each month [Time Frame: 6 months]

CLASI at baseline and each month [Time Frame: 6 months]

SRI-5 response rates compared to historical controls from the BOLD study [Time Frame: 6 months]

Time to flare compared to historical (untreated) controls from the BOLD study [Time Frame: 6 months]

Tender and swollen joint counts at baseline and each month [Time Frame: 6 months]

PGA at baseline and each month [Time Frame: 6 months]

SRI-4 response rates compared to historical controls from the BOLD study [Time Frame: 6 months]

Secondary ID(s)

OMRF 14-18

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

GlaxoSmithKline