Status:
COMPLETED
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
Lead Sponsor:
Oklahoma Medical Research Foundation
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This is a randomized, double blind, placebo controlled trial of abatacept for the treatment of lupus arthritis and other manifestations of lupus. Patients with lupus and at least 3 tender and 3 swolle...
Detailed Description
Research Hypothesis: Abatacept is effective in lupus arthritis and this will be discernible in a small trial with robust endpoints which incorporates withdrawal of background immune suppressants Stud...
Eligibility Criteria
Inclusion
- Signed Written Informed Consent
- Four 1997 revised ACR Classification Criteria for SLE
- Active polyarticular arthritis meeting at minimum BILAG 2004 B definition with a minimum of 3 tender and 3 swollen joints observed at the screening visit
- Men and women 18 to 70 years of age.
- Women of childbearing potential and men with partners of childbearing potential must use an acceptable method of birth control throughout the study
- Women of childbearing potential must have a negative urine pregnancy test at screening and Study Day 1 (baseline visit) and may not be breast feeding
Exclusion
- Current severe, organ-threatening disease (e.g. acute nephritis appropriate for induction therapy, CNS lupus (excepting chorea, cranial neuropathy, and resolving optic neuritis) or any lupus condition requiring cyclophosphamide, biologic therapy, or IV bolus steroids of \>/= 500 mg.
- Subjects who are incapable of understanding or completing study-related assessments.
- Subjects with any condition, whether or not related to SLE, which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Subjects with a history of cancer in the last 5 years, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ.
- Subjects who currently abuse drugs or alcohol.
- Subjects with acute herpes zoster or cytomegalovirus (CMV) within 2 months of screening.
- Subjects who have received any live vaccines within 3 months of first dose.
- Subjects with any serious bacterial infection within the last 3 months, unless treated and resolved with antibiotics, or any chronic bacterial infection (eg, chronic pyelonephritis, osteomyelitis, or bronchiectasis).
- Subjects at risk for tuberculosis (TB).
- Subjects known to be positive for hepatitis B surface antigen or hepatitis C unless negative by PCR or RIBA
- Acute hemolytic anemia with hemoglobin \< 7.0 g/dL or known change in Hg by 2.0 g/dL within four months
- WBC \< 2500/mm3 (\< 3 x 109/L) unless due to chronic stable lupus activity
- Platelets \< 40,000/mm3 (\< 3 x 109/L) (If less than 100,000 must have been stable (within a range of 10,000/mm3 ) within two months of screening or in two tests during the screening period.
- Serum creatinine \> 2 times the ULN
- Serum ALT or AST \> 2.5 times the ULN
- Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
- Known allergy/sensitivity to the study agent or carrier.
- Treatment with investigational drug within 28 days (or 5 terminal half-lives) of the Day 1 dose.
- Cyclophosphamide within 3 months of Day 1 or bolus IV steroids \>/=500 mg within 1 month
- Prednisone \> 20 mg qd after the screening visit
- \-
Key Trial Info
Start Date :
January 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2021
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT02270957
Start Date
January 1 2014
End Date
December 1 2021
Last Update
January 26 2022
Active Locations (1)
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1
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104