An Exploratory Study to Evaluate Changes in Disease Activity and Biomarkers During Treatment With ABR-215757 in Patients With Mild Active Systemic Lupus Erythematosus (SLE). Final Protocol dated 2009-03-16. Protocol Amendment 1 dated 2009-10-13. Protocol Amendment 2 dated 2009-12-02

Active Biotech Research AB0 sites20 target enrollmentApril 27, 2009

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Active Biotech Research AB
Enrollment: 20
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

April 27, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Active Biotech Research AB

Eligibility Criteria

Inclusion Criteria

•1\.Age \> 18 years at the time of signing the informed consent form
•2\.Fulfil at least 4 criteria for SLE as defined by the American College of Rheumatology (ACR).
•3\.Present with active SLE disease with at least one of the following symptoms:
•i) Arthritis – \> 2 joints with pain and signs of inflammation (i.e. tenderness, swelling, or effusion)
•ii) Inflammatory\-type skin rash
•iii) Oral ulcers
•4\.Laboratory values as follows
•\- Hemoglobin \= 100 g/L
•\- Absolute neutrophil count \= 1\.0 x 109/L
•\- Total bilirubin \= 1\.5 x upper limit of normal (ULN)

Exclusion Criteria

•1\.Active severe SLE flare with central nervous system (CNS) manifestations, active renal lupus, systemic vasculitis, active pericarditis, active pleuritis, active peritonitis or other SLE manifestations requiring treatment not allowed by the study protocol.
•2\.Severe renal impairment (estimated or measured GFR \<50%)
•3\.Oral treatment with corticosteroids (\>15 mg/day prednisolone or equivalent) or changes in corticosteroid dosing within 30 days prior to the first dose of study medication. This also includes intraarticular steroid injections or topical treatment for SLE symptoms. Inhaled or topical steroids may be given for reasons other than SLE disease activity (such as asthma, contact dermatitis) as clinically indicated.
•4\.Intravenous corticosteroids within 3 months prior to the first dose of study medication.
•5\.Intravenous cyclophosphamide within 6 months prior to the first dose of study medication.
•6\.Treatment with anti\-rheumatic/immunosuppressive drugs within 3 months prior to first dose of study medication, other than the following medications at stable doses: methotrexate (\=25 mg/week), azathioprine (\=2\.5 mg/kg/day), hydroxychloroquine and mycophenolate mofetil (\=3000 mg/day).
•7\.B\-cell depletion therapy (such as treatment with Rituximab) within 12 months prior to the first dose of study medication.
•8\.Potent inhibitors or inducers of CYP3A4 intravenously or orally within 14 days prior to first dose of study medication.
•9\.History of myocardial infarction or current uncontrolled angina, severe uncontrolled ventricular arrhythmias, symptomatic congestive heart failure, unstable angina pectoris, or electrocardiographic evidence of acute ischemia.
•10\.Marked baseline prolongation of QT/QTc interval (eg, repeated demonstration of a QTc interval \>450 milliseconds