To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Patients in sustained remission
Assessment based on 2-sided stratified Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by baseline glucocorticoid dose group (20-\< 30, 30-\< 40, 40-\< 50 and 50-60 mg/day) and GCA diagnosis (New vs Relapse) at a 5% significance level. Remission is defined as the absence of clinical signs and symptoms of active disease attributable to GCA.
Time frame: 40 weeks (week 12 to week 52)
Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Time frame: Up to 52 weeks
Subject Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Time frame: Up to 52 weeks
Short Form questionnaire-36 (SF-36)
Patient reported outcome assessment
Time frame: Up to 52 weeks
Time from Week 12 to first relapse after achieving remission
measured by investigator
Time frame: 40 weeks (week 12 to week 52)
Erythrocyte sedimentation rate (ESR)
Mean change from baseline.
Time frame: 52 weeks
C-reactive protein (CRP)
Mean change from baseline.
Time frame: 52 weeks
All adverse events and serious adverse events (AEs/SAEs)
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Phoenix, Arizona, United States
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Fullerton, California, United States
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West Hollywood, California, United States
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Denver, Colorado, United States
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Iowa City, Iowa, United States
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Kansas City, Kansas, United States
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Rochester, Minnesota, United States
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New York, New York, United States
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Cleveland, Ohio, United States
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Dayton, Ohio, United States
...and 89 more locations
measured by incidence of AEs and SAEs
Time frame: 52 weeks
Laboratory test abnormalities
measured by laboratory test parameters
Time frame: 52 weeks
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
measured by serum concentration
Time frame: 104 weeks
Positive abatacept response relative to baseline
A validated, sensitive, electrochemiluminescence assay (ECL) method will be used to analyze the presence of anti-abatacept antibodies in serum. Samples that are confirmed positive for antibodies specific to the CTLA4 region of abatacept will be further analyzed with a validated, in vitro, cell-based bioassay to determine whether the sera contained abatacept neutralizing activity.
Time frame: 52 weeks
Cumulative glucocorticoid dose
measured as the total glucocorticoid dose used during the treatment period
Time frame: 52 weeks
EuroQOL 5 Dimensions (EQ-5D-3L)
Patient reported outcome assessment
Time frame: Up to 52 weeks
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Patient reported outcome assessment
Time frame: Up to 52 weeks
Resource Utilization
Assessed by the number of hospitalizations
Time frame: Up to 52 weeks