Brief Summary

This randomized, double-blind, placebo-controlled trial will seek to determine the efficacy of abatacept in GCA. To examine this objective, 62 eligible patients who have newly diagnosed or relapsing GCA within 8 weeks prior to screening will be randomized at a 1:1 ratio to receive subcutaneous abatacept 125mg/week or placebo. Patients who achieve remission will remain on their blinded assignment for 12 months at which time abatacept/placebo will be stopped.

Patients who do not achieve remission by Month 3, who experience a relapse within the first 12 months will have the option of receiving open-label abatacept for a maximum of 12 months.

Conditions

• Giant Cell Arteritis

Intervention / Treatment

• Drug: Abatacept
• Drug: Placebo

Primary Outcome Measures

• The proportion of participants in remission of those randomized to abatacept as compared to placebo. (12 months)
  Remission is defined as the absence of clinical or imaging features of active disease

Countries

Canada, Germany, United States

Locations and Investigators

• Azienda USL IRCCS Di Reggio Emilia, Reggio Emilia, Italy
  • Francesco, Muratore
• medius KLINIKEN gGmbH, Kirchheim Unter Teck, Germany
  • Bernhard, Hellmich

Study Officials

• Peter A Merkel, MD, MPH (Principal Investigator) — University of Pennsylvania
• Carol A Langford, MD, MHS (Principal Investigator) — The Cleveland Clinic
• Jeffrey P Krischer, PhD (Principal Investigator) — University of South Florida