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

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ClinicalTrials.gov Identifier: NCT02270957
Recruitment Status : Active, not recruiting
First Posted : October 22, 2014
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Oklahoma Medical Research Foundation

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 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/= 20 mg prednisone have other background immune suppressants withdrawn at entry.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

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Abatacept Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (The ABC Study)
Study Start Date : January 2014
Actual Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: Abatacept
Patients receive Abatacept 125 mg subcutaneously weekly for six months. An optional continuation up until 12 months is allowed. Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after study medication is started. After this additional rescue is allowed with any standard of care treatment and/or open label abatacept (since patients are blinded) but this additional rescue will define non-response in the primary endpoint at six months.
Biological: Abatacept
Other Name: Orencia

Placebo Comparator: Placebo
Patients receive placebo instead of Abatacept in a double blind fashion. Otherwise participation is the same, including that at the time of treatment failure they may elect any standard of care treatment and/or to begin taking open label abatacept but this rescue will define non-response in the primary endpoint at six months.
Other: Placebo



Primary Outcome Measures :
  1. British Isles Lupus Assessment Group Index-based Combined Lupus Assessment (BICLA) [ Time Frame: 6 months ]
    The British Isles Lupus Assessment Group Index is a scoring system for progress of disease activity over the prior month with a scoring system that rates each organ system as "A" or severe, "B" or moderate, "C" or mild vs no activity in the past month. To meet the BICLA endpoint requires all baseline severe features (BILAG A) improving to moderate (BILAG B), mild or resolved, and all baseline BILAG B features improving to mild or resolved without increase in any other feature on either the BILAG or a different measure called the SLEDAI (SLE Disease Activity Index). Furthermore there must be no increase in Physician's Global Assessment or any rescue medications after the month 2 visit. Only those meeting all of these criteria meet the primary endpoint.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed Written Informed Consent
  2. Four 1997 revised ACR Classification Criteria for SLE
  3. 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
  4. Men and women 18 to 70 years of age.
  5. Women of childbearing potential and men with partners of childbearing potential must use an acceptable method of birth control throughout the study
  6. 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:

  1. 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.
  2. Subjects who are incapable of understanding or completing study-related assessments.
  3. 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.
  4. 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.
  5. Subjects who currently abuse drugs or alcohol.
  6. Subjects with acute herpes zoster or cytomegalovirus (CMV) within 2 months of screening.
  7. Subjects who have received any live vaccines within 3 months of first dose.
  8. 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).
  9. Subjects at risk for tuberculosis (TB).
  10. Subjects known to be positive for hepatitis B surface antigen or hepatitis C unless negative by PCR or RIBA
  11. Acute hemolytic anemia with hemoglobin < 7.0 g/dL or known change in Hg by 2.0 g/dL within four months
  12. WBC < 2500/mm3 (< 3 x 109/L) unless due to chronic stable lupus activity
  13. 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.
  14. Serum creatinine > 2 times the ULN
  15. Serum ALT or AST > 2.5 times the ULN
  16. Any other laboratory test results that, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study.
  17. Known allergy/sensitivity to the study agent or carrier.
  18. Treatment with investigational drug within 28 days (or 5 terminal half-lives) of the Day 1 dose.
  19. Cyclophosphamide within 3 months of Day 1 or bolus IV steroids >/=500 mg within 1 month
  20. Prednisone > 20 mg qd after the screening visit

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270957


Locations
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United States, Oklahoma
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States, 73104
Sponsors and Collaborators
Oklahoma Medical Research Foundation
Bristol-Myers Squibb
Investigators
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Study Director: Joan T Merrill, MD Oklahoma Medical Research Foundation
  Study Documents (Full-Text)

Documents provided by Oklahoma Medical Research Foundation:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02270957    
Other Study ID Numbers: OMRF 13-38
First Posted: October 22, 2014    Key Record Dates
Results First Posted: November 25, 2020
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will share de-identified results through an application process, linked to our institutional research cohorts, where there is a standard operating procedure approval process where research is deemed to be appropriate and relevant to SLE
Supporting Materials: Study Protocol
Time Frame: June 2021-May 2023
Access Criteria: contact the PI at joan-merrill@omrf.org
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immune Checkpoint Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents