A Phase 3 interventional study of Abatacept and Placebo in Giant Cell Arteritis, sponsored by Bristol-Myers Squibb. Withdrawn at 99 sites in 21 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-07-12.
Sponsored by Bristol-Myers Squibb · Phase 3, Interventional, and Treatment
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.
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Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Drug: Abatacept · Drug: Glucocorticoid Treatment
Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Other: Placebo · Drug: Glucocorticoid Treatment
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Other: Placebo · Drug: Glucocorticoid Treatment
Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
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)
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
This study is withdrawn, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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