Clinical trial NCT03192969: 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)
Official 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Giant Cell Arteritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2017-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.


Eligibility 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

Primary outcomes:
measure: Patients in sustained remission
timeFrame: 40 weeks (week 12 to week 52)
Secondary outcomes:
measure: Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
timeFrame: Up to 52 weeks
measure: Subject Assessment of Disease Activity according to visual analog scale (VAS)
timeFrame: Up to 52 weeks
measure: Short Form questionnaire-36 (SF-36)
timeFrame: Up to 52 weeks
measure: Time from Week 12 to first relapse after achieving remission
timeFrame: 40 weeks (week 12 to week 52)
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 52 weeks
measure: C-reactive protein (CRP)
timeFrame: 52 weeks
measure: All adverse events and serious adverse events (AEs/SAEs)
timeFrame: 52 weeks
measure: Laboratory test abnormalities
timeFrame: 52 weeks
measure: Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
timeFrame: 104 weeks
measure: Positive abatacept response relative to baseline
timeFrame: 52 weeks
measure: Cumulative glucocorticoid dose
timeFrame: 52 weeks
measure: EuroQOL 5 Dimensions (EQ-5D-3L)
timeFrame: Up to 52 weeks
measure: Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
timeFrame: Up to 52 weeks
measure: Resource Utilization
timeFrame: Up to 52 weeks
Other outcomes:
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country: Serbia
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state: Essex
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state: Tyne and Wear
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Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: