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

NCT02270970 | Unknown Phase 4 DMC

• 1 other identifier: OMRF 14-18
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 regimens to determine immunologic differences between patients who do versus do not meet clinical response criteria.

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

• BLAST-50 response rate in clinical responders vs non responders

  The BLyS Activity Signature Test will determine the rate at which pre-specified biomarkers of BLyS signaling in B Cells are reduced at least 50% in those who do or do not meet the SRI-4 clinical response criteria (the latter defined as a decrease in the SLE Disease Activity Index (SLEDAI) of 4 or more points, no increase in the BILAG index of disease activity, no more than a 10% increase in Physician's Global Assessment and no rescue medications after Month 2

  3 months

Secondary Outcomes (8)

• Time to flare compared to historical (untreated) controls from the BOLD study

  6 months

• SRI-4 response rates compared to historical controls from the BOLD study

  6 months

• SRI-5 response rates compared to historical controls from the BOLD study

  6 months

• BICLA response rates compared to historical controls from the BOLD study

  6 months

• Tender and swollen joint counts at baseline and each month

  6 months

Other Outcomes (2)

• Exploratory Biomarker Studies

  6 months

• Descriptive Safety Data

  6 months

Study Arms (2)

Responders to Belimumab

ACTIVE COMPARATOR

This Arm is defined as patients who complete 6 months of belimumab without and meet the primary endpoint

Biological: belimumab

Non Responders to Belimumab

ACTIVE COMPARATOR

This Arm is defined as patients who complete 6 months of study and do not meet the primary endpoint

Biological: belimumab

Interventions

belimumab BIOLOGICAL

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

Also known as: BenLysta

Non Responders to Belimumab; Responders to Belimumab

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Oklahoma Medical Research Foundation: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

belimumab

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Katherine Thanou, M.D.

  Oklahoma Medical Research Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joan T Merrill, M.D.

CONTACT

405 271 7805; joan-merrill@omrf.org

Fredonna Carthen

CONTACT

405 271 7805; fredonna-carthen@omrf.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2014
• First Posted: October 22, 2014
• Study Start: October 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: December 7, 2017

Record last verified: 2017-12

Locations

US (1)