Recruiting

Belimumab

Sponsor:

Oklahoma Medical Research Foundation

Code:

NCT02270970

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

Interventions

belimumab

Study Details

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

Study ID

NCT02270970

Start date

Oct, 2014

Status verified date

Dec, 2017

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 70

Healthy Volunteers: Not accepted

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

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Study Design

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Responders to Belimumab

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

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

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Oklahoma Medical Research Foundation

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Katherine Thanou, MD

More Information

Sponsor

Oklahoma Medical Research Foundation

Last update posted

Dec 7, 2017

Last verified

Dec, 2017

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oklahoma Medical Research Foundation on 2017-12-07.