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)
Status and phase
Withdrawn
Phase 3
Conditions
Giant Cell Arteritis
Treatments
Other: Placebo
Drug: Abatacept
Drug: Glucocorticoid Treatment
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
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.
Sex
All
Ages
50+ years old
Volunteers
No Healthy Volunteers
Inclusion and 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
0 participants in 3 patient groups, including a placebo group
Abatacept Combination Therapy
Experimental group
Description:
Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Treatment:
Drug: Abatacept
Drug: Glucocorticoid Treatment
Placebo Monotherapy- 28 Weeks
Placebo Comparator group
Description:
Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Treatment:
Other: Placebo
Drug: Glucocorticoid Treatment
Placebo Monotherapy- 52 Weeks
Placebo Comparator group
Description:
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Treatment:
Other: Placebo
Drug: Glucocorticoid Treatment
Trial contacts and locations
99
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Data sourced from clinicaltrials.gov
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