Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046774
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2002-10-02
Brief Title:
Monoclonal Antibody Treatment for Systemic Lupus Erythematosus
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Phase I Open-Labeled Dose-Ascending Clinical Trial of Immunotherapy of MRA A Humanized Anti-IL 6 Receptor Monoclonal Antibody In Patients With Systemic Lupus Erythematosus
Status:
COMPLETED
Status Verified Date:
2017-09-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine the safety and effects of the monoclonal antibody MRA in patients with systemic lupus erythematosus SLE Antibodies normally fight invading organisms In autoimmune diseases such as lupus however antibodies attack the body s own tissues MRA is an antibody manufactured in the laboratory that blocks the action of interleukin-6 IL-6 a substance that increases antibody production and is involved in inflammation that may cause organ damage in SLE
Patients 18 years of age and older with moderately active systemic lupus erythematosus may be eligible for this 6-month study Candidates will be screened with blood and urine tests chest X-ray electrocardiogram EKG and screening tests for certain cancers
Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the clinic The MRA is infused over a period of about 1 hour through a catheter thin plastic tube inserted into an arm vein Patients will be observed for 1 to 2 hours after each infusion for drug side effects For the first and last infusions patients will return to the clinic for blood tests 24 to 48 hours after the infusion Additional tests may be done if medically indicated
Three different doses of MRA will be used in three groups of patients The first group 4 patients will receive the lowest dose If this dose is well tolerated a second group 6 patients will receive a higher dose If this dose is also well tolerated a third group 6 patients will receive the highest study dose
Patients will be evaluated at various intervals for up to 3 months after the last dose of MRA The follow-up visits will include a review of the patient s medical history a physical examination blood and urine tests and an EKG
Patients 18 years of age and older with moderately active systemic lupus erythematosus may be eligible for this 6-month study Candidates will be screened with blood and urine tests chest X-ray electrocardiogram EKG and screening tests for certain cancers
Participants will receive a total of up to seven infusions of MRA given every 2 weeks in the clinic The MRA is infused over a period of about 1 hour through a catheter thin plastic tube inserted into an arm vein Patients will be observed for 1 to 2 hours after each infusion for drug side effects For the first and last infusions patients will return to the clinic for blood tests 24 to 48 hours after the infusion Additional tests may be done if medically indicated
Three different doses of MRA will be used in three groups of patients The first group 4 patients will receive the lowest dose If this dose is well tolerated a second group 6 patients will receive a higher dose If this dose is also well tolerated a third group 6 patients will receive the highest study dose
Patients will be evaluated at various intervals for up to 3 months after the last dose of MRA The follow-up visits will include a review of the patient s medical history a physical examination blood and urine tests and an EKG
Detailed Description:
Interleukin-6 IL-6 levels are elevated in both human and murine systemic lupus erythematosus SLE Blocking the action of IL-6 ameliorates disease activity in murine models of SLE MRA is a humanized monoclonal antibody against the human IL-6 receptor Data from clinical trials in patients with rheumatoid arthritis suggest that MRA may be a safe agent to block the effect of IL-6 and therefore may be used to evaluate the effects of IL-6 blockade in patients with SLE In this open label dose-escalating Phase I study up to 27 subjects with moderately active SLE may be enrolled Subjects will be treated with bi-weekly infusions of one of three doses 2mgkg 4 mgkg or 8 mgkg of MRA for 12 weeks and followed for 8 weeks after the last dose Patients with or without lupus nephritis may be enrolled if they do not require immediate immunosuppressive therapy other than prednisone at doses of less than or equal to 03 mgkgday Safety will be evaluated using standard clinical and laboratory parameters To assess the potential effect of MRA on SLE clinical and laboratory evaluations and surrogate markers of inflammation and disease activity such as autoantibody production and lymphocyte subsets will be compared before and after the treatment Patients who either do not tolerate the drug or those who have a clinically significant increase in their disease activity that does not respond to moderate doses of corticosteroids will be withdrawn from the protocol
If this regimen is shown to be well tolerated studies of efficacy will be planned This agent is expected to be devoid of the most common toxicities of therapies commonly used in the treatment of SLE such as myelosuppression amenorrhea and osteoporosis
This study will provide important preliminary information about the safety and possible effect of IL-6 blockade in SLE patients an intervention that has been successful in animal models but has not yet been studied in humans
If this regimen is shown to be well tolerated studies of efficacy will be planned This agent is expected to be devoid of the most common toxicities of therapies commonly used in the treatment of SLE such as myelosuppression amenorrhea and osteoporosis
This study will provide important preliminary information about the safety and possible effect of IL-6 blockade in SLE patients an intervention that has been successful in animal models but has not yet been studied in humans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 02-AR-0272 | None | None | None |