Abatacept for the Treatment of Giant Cell Arteritis
ConditionGiant Cell Arteritis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Pennsylvania
About this trial
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.
Eligibility criteria
Qualifiers
A diagnosis of newly diagnosed or relapsing GCA. Diagnostic criteria for GCA
Age at disease onset ≥ 50 years.
New onset or new type of localized pain in the head.
ESR of > 40 mm in the first hour by the Westergren method or CRP measurement above the laboratory normal limit.
Disqualifiers
Any acute infection within 60 days prior to randomization that required hospitalization or treatment with parenteral antibiotics.
Any acute infection within 30 days prior to randomization that required oral antimicrobial or antiviral therapy.
Patients with history of chronic or recurrent bacterial infection (such as chronic pyelonephritis, osteomyelitis, and bronchiectasis etc.).
Patients with a history of recurrent herpes zoster (more than 1 episode) or disseminated (more than 1 dermatome) herpes zoster or disseminated herpes simplex, or ophthalmic zoster. Symptoms of herpes zoster or herpes simplex must have resolved more than 60 days prior to screening.
Trial design
Treatments tested in this trial
- Abatacept
- Placebo
Treatment groups
78 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov