Abatacept for the Treatment of Giant Cell Arteritis

PHASE3RecruitingINTERVENTIONAL
Enrollment

78

Participants

Timeline

Start Date

March 29, 2021

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Giant Cell Arteritis
Interventions
DRUG

Abatacept

Participants randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.

DRUG

Placebo

Participants randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.

Trial Locations (8)

10021

RECRUITING

Hospital for Special Surgery, New York

19104

RECRUITING

University of Pennsylvania, Philadelphia

37240

RECRUITING

Vanderbilt University, Nashville

44195

RECRUITING

Cleveland Clinic, Cleveland

55905

RECRUITING

Mayo Clinic, Rochester

Unknown

ACTIVE_NOT_RECRUITING

St. Joseph's Healthcare, Hamilton

ACTIVE_NOT_RECRUITING

Mount Sinai Hospital, Toronto

H4J 1C5

RECRUITING

Hôpital du Sacré-Coeur de Montréal Université de Montréal, Montreal

All Listed Sponsors
lead

University of Pennsylvania

OTHER

NCT04474847 - Abatacept for the Treatment of Giant Cell Arteritis | Biotech Hunter | Biotech Hunter