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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 : Recruiting
First Posted : October 22, 2014
Last Update Posted : December 7, 2017
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/= 20 mg prednisone have other background immune suppressants withdrawn at entry.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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019

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 Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after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 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.
Other: Placebo



Primary Outcome Measures :
  1. BILAG-based Combined Lupus Assessment (BICLA) [ Time Frame: 6 months ]
    All baseline severe features (BILAG A) improving to moderate (BILAG B) or better and all baseline BILAG B features improving to mild or resolved (C or D) without increase in any other feature on BILAG or SLEDAI (SLE Disease Activity Index), increase in Physician's Global Assessment or rescue medications after the month 2 visit


Secondary Outcome Measures :
  1. BICLA and SRI at each month [ Time Frame: 6 months ]
    BICLA as defined in primary endpoint. SRI is SLE Responder Index defined as decrease of SLEDAI of at least 4 (or 5) points with no increased BILAG or PGA

  2. Mean SLEDAI at baseline vs 6 months [ Time Frame: 6 months ]
    SLEDAI is defined as the SLE Disease Activity Index score

  3. Mean BILAG at baseline vs 6 months [ Time Frame: 6 months ]
    BILAG is defined above. A cumulative score is given for additive severity in each active organ

  4. Mean CLASI score at baseline vs 6 months [ Time Frame: 6 months ]
    CLASI is a Cutaneous Lupus scoring system which also results in a cumulative score

  5. LFA REAL scoring at baseline vs 6 months [ Time Frame: 6 months ]
    LFA REAL stands for Lupus Foundation of America Rapid Evaluation of Activity in Lupus


Other Outcome Measures:
  1. Exploratory Biologic Endpoints [ Time Frame: 6 months ]
    Patients with or without increased ratio of TH17/Treg signals or activated B signals (e.g. ErK phosphorylation) at baseline will be compared for response rates

  2. Safety Data [ Time Frame: 6 months ]
    Descriptive analysis of SAEs, AEs and AEs of special interest



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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


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


Contacts
Contact: Aikaterini Thanou, M.D. 405 271 7805 ext 34434 aikaterini-thanou@omrf.org
Contact: Fredonna Carthen 405 271 7805 ext 5 fredonna-carthen@omrf.org

Locations
United States, Oklahoma
Oklahoma Medical Research Foundation Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Fredonna Carthen    405-271-7805    fredonna-carthen@omrf.org   
Contact: Heather Miller, LPN    405-271-7805 ext 34824    heather-miller@omrf.org   
Sub-Investigator: Joan T Merrill, M.D.         
Principal Investigator: Aikaterini Thanou, M.D.         
Sub-Investigator: Eliza Chakravarty, M.D.         
Sub-Investigator: Judith A James, M.D., PhD         
Sponsors and Collaborators
Oklahoma Medical Research Foundation
Bristol-Myers Squibb
Investigators
Study Director: Joan T Merrill, MD Oklahoma Medical Research Foundation

Responsible Party: Oklahoma Medical Research Foundation
ClinicalTrials.gov Identifier: NCT02270957     History of Changes
Other Study ID Numbers: OMRF 13-38
First Posted: October 22, 2014    Key Record Dates
Last Update Posted: December 7, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents