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

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ClinicalTrials.gov Identifier: NCT02270970
Recruitment Status : Recruiting
First Posted : October 22, 2014
Last Update Posted : December 7, 2017
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: belimumab Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Belimumab Impact on a BLyS Activity Signature Test in the Absence of Confounding Polypharmacy
Study Start Date : October 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Belimumab

Arm Intervention/treatment
Active Comparator: Responders to Belimumab
This Arm is defined as patients who complete 6 months of belimumab without and meet the primary endpoint
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
Other Name: BenLysta

Active Comparator: Non Responders to Belimumab
This Arm is defined as patients who complete 6 months of study and do not meet the primary endpoint
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
Other Name: BenLysta




Primary Outcome Measures :
  1. BLAST-50 response rate in clinical responders vs non responders [ Time Frame: 3 months ]
    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


Secondary Outcome Measures :
  1. Time to flare compared to historical (untreated) controls from the BOLD study [ Time Frame: 6 months ]
    The patients taking part in the BOLD study were in a very similar protocol but without an interventional study medication once the steroids were given. 75% flared within 4 months and 97.6% flared within 6 months of the last steroid shot. Thus they can serve as historical controls of some value in this study which does not include a placebo group. Flare will be defined, as in the BOLD study as an increase in SLEDAI of 4 or more points or one grade worsening in at least one BILAG-defined score, also requiring the clinician's determination of a clinically significant worsening and intention to treat

  2. SRI-4 response rates compared to historical controls from the BOLD study [ Time Frame: 6 months ]
    The SRI-4 is identical to the SRI-4 described in the primary endpoint

  3. SRI-5 response rates compared to historical controls from the BOLD study [ Time Frame: 6 months ]
    The SRI-5 is identical to the SRI-4 described in the primary endpoint except that it requires at least a 5 point improvement in the SLEDAI. The BICLA (BILAG-based Combined Lupus Assessment) requires one grade of improvement in every BILAG score present at baseline along with no worsening in any BILAG or SLEDAI descriptor, no more than a 10% worsening by Physician's Global Assessment and no further rescue treatment after 2 months

  4. BICLA response rates compared to historical controls from the BOLD study [ Time Frame: 6 months ]
    The BICLA (BILAG-based Combined Lupus Assessment) requires one grade of improvement in every BILAG score present at baseline along with no worsening in any BILAG or SLEDAI descriptor, no more than a 10% worsening by Physician's Global Assessment and no further rescue treatment after 2 months

  5. Tender and swollen joint counts at baseline and each month [ Time Frame: 6 months ]
    Joint counts will be performed using the ACR 28 joint count format

  6. PGA at baseline and each month [ Time Frame: 6 months ]
    PGA stands for Physician's Global Assessment which is a 100mm scale based on the SELENA SLEDAI version of the PGA which includes landmarks for mild, moderate and severe disease activity

  7. CLASI at baseline and each month [ Time Frame: 6 months ]
    This is a scoring system for mucocutaneous manifestations of lupus segmented by area of the body and severity

  8. LFA-REAL at baseline and each month [ Time Frame: 6 months ]
    This is a series of scales based on the SELENA SLEDAI PGA which breaks down the assessment by organ system and includes assessments by both clinicians and patients


Other Outcome Measures:
  1. Exploratory Biomarker Studies [ Time Frame: 6 months ]
    To be determined because it will be exploratory

  2. Descriptive Safety Data [ Time Frame: 6 months ]
    Serious Adverse Events, all Adverse Events and Adverse Events of Special Interest will be reported



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270970


Contacts
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Contact: Joan T Merrill, M.D. 405 271 7805 joan-merrill@omrf.org
Contact: Fredonna Carthen 405 271 7805 ext 5 fredonna-carthen@omrf.org

Locations
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United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Joan T Merrill, MD    405-271-7805    JTMmail@aol.com   
Contact: Judith A James, MD PhD    405-271-7805    judith-james@omrf.org   
Sub-Investigator: Joan T Merrill, M.D.         
Sub-Investigator: Judith A James, MD PhD         
Sub-Investigator: Joel Guthridge, PhD         
Principal Investigator: Katherine Thanou, MD         
Sub-Investigator: Eliza Chakravarty, MD         
Sub-Investigator: Teresa Aberle, PA         
Sponsors and Collaborators
Oklahoma Medical Research Foundation
GlaxoSmithKline
Investigators
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Principal Investigator: Katherine Thanou, M.D. Oklahoma Medical Research Foundation

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Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02270970     History of Changes
Other Study ID Numbers: OMRF 14-18
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Belimumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs