Clarification of Abatacept Effects in SLE With Integrated Biologic and Clinical Approaches (ABC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Systemic Lupus Erythematosus||Biological: Abatacept Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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 Background immune suppressants are withdrawn at the beginning of the study and the option of depomedrol up to 320 mg total (in divided doses) is allowed at any time up through the visit 2 months after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.
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.
- 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.
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
|United States, Oklahoma|
|Oklahoma Medical Research Foundation|
|Oklahoma City, Oklahoma, United States, 73104|
|Study Director:||Joan T Merrill, MD||Oklahoma Medical Research Foundation|