Phase 2
N=66
Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches
Systemic Lupus Erythematosus
Bottom Line
View on ClinicalTrials.gov: NCT02270957 ↗Enrolled (actual)
66
Serious AEs
15.2%
Results posted
Nov 2020
Primary outcome: Primary: British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) — 8; 8 Participants — p=>0.999
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Abatacept (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Oklahoma Medical Research Foundation
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) |
8; 8 | >0.999 |
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 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/= 20 mg prednisone have other background immune suppressants withdrawn at entry.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
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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 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
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Data sourced from ClinicalTrials.gov (NCT02270957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.