Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Blinded AbataceptExperimental treatment 1 intervention
Group B: Blinded PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The proportion of participants in remission of those randomized to abatacept as compared to placebo.

Remission is defined as the absence of clinical or imaging features of active disease

Time frame
12 months

Secondary outcomes

1

Safety of abatacept in GCA

Safety of abatacept in patients with GCA as assessed by reported adverse events.

Time frame
12 months
2

Health-related quality of life in those treated with abatacept versus placebo: SF-36

Health-related quality of life in those treated with abatacept versus placebo as assessed using the SF-36

Time frame
12 months
3

Health-related quality of life in those treated with abatacept versus placebo: PROMIS questionnaire

Health-related quality of life in those treated with abatacept versus placebo as assessed using a PROMIS questionnaire

Time frame
12 months
4

Duration of glucocorticoid-free remission from Month 6 to Month 12

Effect of abatacept on increasing duration of glucocorticoid-free periods for participants.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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