Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches

Completed · Phase 2 · Has a placebo group

Conditions studied: Systemic Lupus Erythematosus

In brief

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 swollen joints and \</= 20 mg prednisone have other background immune suppressants withdrawn at entry. They can elect to receive up to a total of 320 mg depomedrol (in two or more injections) between the screening visit and the visit 2 months after dosing begins. Abatacept (125 mg) or placebo is administered in weekly subcutaneous doses. After 3 months of treatment patients who are not responding may elect to receive open label abatacept with or without additional standard of care therapies. Such patients are considered non responders. The primary endpoint is the British Isles Lupus Assessment Group Index (BILAG)-linked Combined Lupus Assessment (BICLA) which will require a clinically significant improvement in arthritis and other active features of lupus

Key facts

Study ID: NCT02270957
Run by: Oklahoma Medical Research Foundation
People needed: 66
Starts: 2014-01-01
Expected to finish: 2021-12-01
Last updated by the study team: 2022-01-26

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Oklahoma Medical Research Foundation — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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