Abatacept for the Treatment of Giant Cell Arteritis

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
University of Pennsylvania
Study ID
NCT04474847
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Giant Cell Arteritis

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abatacept — DRUG
    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.
  • Placebo — DRUG
    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.

Study Details

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.

Key Dates

Start date
Mar 29, 2021
Status verified
Jan 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Blinded Abatacept
    Participants will receive blinded abatacept 125 mg administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission.
  • Placebo Comparator: Blinded Placebo
    Participants will receive blinded placebo. Placebo will be administered by subcutaneous injection once a week for at least 12 months. Subjects may be removed from treatment earlier due to a disease relapse, disease worsening, or if they have not achieved remission.

Primary Outcome Measure

The proportion of participants in remission of those randomized to abatacept as compared to placebo. [ Time Frame: 12 months ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Mayo ClinicRochesterMinnesota55905
Jennifer Sletten
[email protected]
Kenneth Warrington, MD (PRINCIPAL_INVESTIGATOR)
Hospital for Special SurgeryNew YorkNew York10021
Janvi Bhatia
[email protected]
Robert Spiera, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
Brittany McKnight
[email protected]
Carol Langford, MD, MHS (PRINCIPAL_INVESTIGATOR)
University of PennsylvaniaPhiladelphiaPennsylvania19104
Jessica Nguyen
[email protected]
Vanderbilt UniversityNashvilleTennessee37240
Pamela Schlairet
[email protected]
Kevin Byram, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Rochester, MN

By research site
Mayo Clinic· Rochester, MNHospital for Special Surgery· New York, NYCleveland Clinic· Cleveland, OHUniversity of Pennsylvania· Philadelphia, PAVanderbilt University· Nashville, TN

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