A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03192969
• Date of registration: 14/06/2017
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: A Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)
• Scientific title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis
• Date of first enrolment: July 15, 2017
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT03192969
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Bulgaria, Canada, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Romania, Serbia, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
visit www.BMSStudyConnect.com

Inclusion Criteria:

- New headache (new onset or new type of localized pain in the head)

- Elevated ESR (= 50 mm/h by the Westergren method) or CRP = 1 mg/dL

- Temporal artery abnormality (i.e. temporal artery tenderness to palpation or decreased
pulsation, unrelated to arteriosclerosis of cervical arteries)

- Temporal artery biopsy showing vasculitis characterized by a predominance of
mononuclear cell infiltration or granulomatous inflammation, usually with
multinucleated giant cells

- Large vessel biopsy showing vasculitis characterized by a predominance of mononuclear
cell infiltration or granulomatous inflammation, usually with multinucleated giant
cells or characteristic changes of large vessel stenosis or aneurysm secondary to GCA
as seen by arteriography (Magnetic Resonance Imaging/ Magnetic Resonance Angiography),
ultrasound (eg, halo sign on color duplex sonography), or CT scan

- Patients must be treated with prednisone or prednisolone of 20-60 mg/day (prednisone
equivalent) and be on a dose between 20-60 mg/day for at least 2 weeks prior to
enrollment into the study

Exclusion Criteria:

- Rheumatic disease other than GCA such as Takayasu's Arteritis, granulomatosis with
polyangiitis (Wegener's), rheumatoid arthritis, systemic lupus erythematosus

- Patients with unilateral blindness (partial or complete) or who have unstable or
recurrent visual symptoms attributable to GCA within 4 weeks of randomization

- Patients with a history of dissection of aorta

- Patients with a history of myocardial infarction, stroke or transient ischemic attack
attributable to GCA within the 3 months of screening

- Patients who have been treated with intravenous ("pulse") doses of glucocorticoids
defined as methylprednisolone > 1000 mg/day if given within 6 weeks of randomization

- Patients who will require oral or IV glucocorticoid treatment during the trial for
conditions other than GCA

- Patients at risk of tuberculosis

Other protocol defined inclusion/exclusion criteria could apply



Age minimum: 50 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Giant Cell Arteritis

Intervention(s)

Drug: Abatacept

Drug: Glucocorticoid Treatment

Other: Placebo

Primary Outcome(s)

Patients in sustained remission [Time Frame: 40 weeks (week 12 to week 52)]

Secondary Outcome(s)

Cumulative glucocorticoid dose [Time Frame: 52 weeks]

Positive abatacept response relative to baseline [Time Frame: 52 weeks]

Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a [Time Frame: Up to 52 weeks]

Short Form questionnaire-36 (SF-36) [Time Frame: Up to 52 weeks]

Erythrocyte sedimentation rate (ESR) [Time Frame: 52 weeks]

EuroQOL 5 Dimensions (EQ-5D-3L) [Time Frame: Up to 52 weeks]

Subject Assessment of Disease Activity according to visual analog scale (VAS) [Time Frame: Up to 52 weeks]

All adverse events and serious adverse events (AEs/SAEs) [Time Frame: 52 weeks]

Resource Utilization [Time Frame: Up to 52 weeks]

Laboratory test abnormalities [Time Frame: 52 weeks]

Cmin (µg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection [Time Frame: 104 weeks]

Physician's Global Assessment of Disease Activity according to visual analog scale (VAS) [Time Frame: Up to 52 weeks]

C-reactive protein (CRP) [Time Frame: 52 weeks]

Time from Week 12 to first relapse after achieving remission [Time Frame: 40 weeks (week 12 to week 52)]

Secondary ID(s)

IM101-604

2016-002697-12

Source(s) of Monetary Support

Please refer to primary and secondary sponsors