NCT03192969

A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Giant Cell Arteritis

Interventions

Type	Name	Description
DRUG	Abatacept	Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
OTHER	Placebo	Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
DRUG	Glucocorticoid Treatment	Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)

Timeline

• Start date: 2017-07-15
• Primary completion: 2020-06-07
• Completion: 2021-11-23
• First posted: 2017-06-20
• Last updated: 2017-07-12

Locations

99 sites across 21 countries: United States, Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study