Back to resultsA Study to Evaluate Efficacy and Safety of Subcutaneous Abatacept With Steroid Treatment Compared to Steroid Treatment Alone in Adults With Giant Cell Arteritis (GCA)
Primary Purpose
Giant Cell Arteritis
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Abatacept
Placebo
Glucocorticoid Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Giant Cell Arteritis
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
Sites / Locations
- Local Institution
- Local Institution
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Placebo Comparator
Arm Label
Abatacept Combination Therapy
Placebo Monotherapy- 28 Weeks
Placebo Monotherapy- 52 Weeks
Arm Description
Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Outcomes
Primary Outcome Measures
Patients in sustained remission
Assessment based on 2-sided stratified Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by baseline glucocorticoid dose group (20-< 30, 30-< 40, 40-< 50 and 50-60 mg/day) and GCA diagnosis (New vs Relapse) at a 5% significance level. Remission is defined as the absence of clinical signs and symptoms of active disease attributable to GCA.
Secondary Outcome Measures
Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Subject Assessment of Disease Activity according to visual analog scale (VAS)
measured by assessment parameters
Short Form questionnaire-36 (SF-36)
Patient reported outcome assessment
Time from Week 12 to first relapse after achieving remission
measured by investigator
Erythrocyte sedimentation rate (ESR)
Mean change from baseline.
C-reactive protein (CRP)
Mean change from baseline.
All adverse events and serious adverse events (AEs/SAEs)
measured by incidence of AEs and SAEs
Laboratory test abnormalities
measured by laboratory test parameters
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
measured by serum concentration
Positive abatacept response relative to baseline
A validated, sensitive, electrochemiluminescence assay (ECL) method will be used to analyze the presence of anti-abatacept antibodies in serum. Samples that are confirmed positive for antibodies specific to the CTLA4 region of abatacept will be further analyzed with a validated, in vitro, cell-based bioassay to determine whether the sera contained abatacept neutralizing activity.
Cumulative glucocorticoid dose
measured as the total glucocorticoid dose used during the treatment period
EuroQOL 5 Dimensions (EQ-5D-3L)
Patient reported outcome assessment
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Patient reported outcome assessment
Resource Utilization
Assessed by the number of hospitalizations
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03192969
Brief 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)
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Business objectives have changed
Study Start Date
July 15, 2017 (Anticipated)
Primary Completion Date
June 7, 2020 (Anticipated)
Study Completion Date
November 23, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Giant Cell Arteritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abatacept Combination Therapy
Arm Type
Experimental
Arm Description
Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)
Arm Title
Placebo Monotherapy- 28 Weeks
Arm Type
Placebo Comparator
Arm Description
Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)
Arm Title
Placebo Monotherapy- 52 Weeks
Arm Type
Placebo Comparator
Arm Description
Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly
Intervention Type
Drug
Intervention Name(s)
Abatacept
Intervention Description
Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
Intervention Type
Drug
Intervention Name(s)
Glucocorticoid Treatment
Intervention Description
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
Primary Outcome Measure Information:
Title
Patients in sustained remission
Description
Assessment based on 2-sided stratified Cochran-Mantel-Haenszel (CMH) chi-square test, stratified by baseline glucocorticoid dose group (20-< 30, 30-< 40, 40-< 50 and 50-60 mg/day) and GCA diagnosis (New vs Relapse) at a 5% significance level. Remission is defined as the absence of clinical signs and symptoms of active disease attributable to GCA.
Time Frame
40 weeks (week 12 to week 52)
Secondary Outcome Measure Information:
Title
Physician's Global Assessment of Disease Activity according to visual analog scale (VAS)
Description
measured by assessment parameters
Time Frame
Up to 52 weeks
Title
Subject Assessment of Disease Activity according to visual analog scale (VAS)
Description
measured by assessment parameters
Time Frame
Up to 52 weeks
Title
Short Form questionnaire-36 (SF-36)
Description
Patient reported outcome assessment
Time Frame
Up to 52 weeks
Title
Time from Week 12 to first relapse after achieving remission
Description
measured by investigator
Time Frame
40 weeks (week 12 to week 52)
Title
Erythrocyte sedimentation rate (ESR)
Description
Mean change from baseline.
Time Frame
52 weeks
Title
C-reactive protein (CRP)
Description
Mean change from baseline.
Time Frame
52 weeks
Title
All adverse events and serious adverse events (AEs/SAEs)
Description
measured by incidence of AEs and SAEs
Time Frame
52 weeks
Title
Laboratory test abnormalities
Description
measured by laboratory test parameters
Time Frame
52 weeks
Title
Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection
Description
measured by serum concentration
Time Frame
104 weeks
Title
Positive abatacept response relative to baseline
Description
A validated, sensitive, electrochemiluminescence assay (ECL) method will be used to analyze the presence of anti-abatacept antibodies in serum. Samples that are confirmed positive for antibodies specific to the CTLA4 region of abatacept will be further analyzed with a validated, in vitro, cell-based bioassay to determine whether the sera contained abatacept neutralizing activity.
Time Frame
52 weeks
Title
Cumulative glucocorticoid dose
Description
measured as the total glucocorticoid dose used during the treatment period
Time Frame
52 weeks
Title
EuroQOL 5 Dimensions (EQ-5D-3L)
Description
Patient reported outcome assessment
Time Frame
Up to 52 weeks
Title
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a
Description
Patient reported outcome assessment
Time Frame
Up to 52 weeks
Title
Resource Utilization
Description
Assessed by the number of hospitalizations
Time Frame
Up to 52 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Local Institution
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Local Institution
City
West Hollywood
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Local Institution
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Local Institution
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Local Institution
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Local Institution
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Local Institution
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Local Institution
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Local Institution
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Local Institution
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Local Institution
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Local Institution
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702
Country
United States
Facility Name
Local Institution
City
Northmead
State/Province
New South Wales
ZIP/Postal Code
2152
Country
Australia
Facility Name
Local Institution
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Local Institution
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5001
Country
Australia
Facility Name
Local Institution
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Local Institution
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Local Institution
City
Victoria Park
State/Province
Western Australia
ZIP/Postal Code
6100
Country
Australia
Facility Name
Local Institution
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Local Institution
City
Stockerau
ZIP/Postal Code
2000
Country
Austria
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Li?ge
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution
City
Sofia
State/Province
Sofia-grad
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Local Institution
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Local Institution
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Local Institution
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Local Institution
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Local Institution
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Local Institution
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Local Institution
City
Holstebro
ZIP/Postal Code
DK-7500
Country
Denmark
Facility Name
Local Institution
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Local Institution
City
Silkeborg
ZIP/Postal Code
DK-8600
Country
Denmark
Facility Name
Local Institution
City
Tallinn
ZIP/Postal Code
11312
Country
Estonia
Facility Name
Local Institution
City
Tallinn
ZIP/Postal Code
EE-13419
Country
Estonia
Facility Name
Local Institution
City
Tartu
ZIP/Postal Code
50107
Country
Estonia
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75679
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Local Institution
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Local Institution
City
Freiburg im Breisgau
ZIP/Postal Code
79095
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22767
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
D30625
Country
Germany
Facility Name
Local Institution
City
Herne
ZIP/Postal Code
44652
Country
Germany
Facility Name
Local Institution
City
Kirchheim
ZIP/Postal Code
73230
Country
Germany
Facility Name
Local Institution
City
Rostock
ZIP/Postal Code
18059
Country
Germany
Facility Name
Local Institution
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Local Institution
City
W?rzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Local Institution
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Local Institution
City
Larissa
ZIP/Postal Code
41110
Country
Greece
Facility Name
Local Institution
City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
Local Institution
City
Dublin
Country
Ireland
Facility Name
Local Institution
City
Catania
ZIP/Postal Code
95124
Country
Italy
Facility Name
Local Institution
City
Genova
ZIP/Postal Code
16132
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20157
Country
Italy
Facility Name
Local Institution
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Prato
ZIP/Postal Code
51900
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
Facility Name
Local Institution
City
Enschede
ZIP/Postal Code
7513 ER
Country
Netherlands
Facility Name
Local Institution
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Local Institution
City
Helmond
ZIP/Postal Code
5707 HA
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3059XN
Country
Netherlands
Facility Name
Local Institution
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Local Institution
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Local Institution
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Local Institution
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Local Institution
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Local Institution
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Local Institution
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
Local Institution
City
L'Hospitalet de Llobregat
ZIP/Postal Code
08907
Country
Spain
Facility Name
Local Institution
City
La Laguna
ZIP/Postal Code
38320
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Local Institution
City
Vitoria
ZIP/Postal Code
01009
Country
Spain
Facility Name
Local Institution
City
Stockholm
ZIP/Postal Code
SE-18288
Country
Sweden
Facility Name
Local Institution
City
Uppsala
ZIP/Postal Code
755 92
Country
Sweden
Facility Name
Local Institution
City
V?ster?s
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Local Institution
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Local Institution
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Local Institution
City
Freiburg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Local Institution
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Local Institution
City
Z?rich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Local Institution
City
Westcliff-on-Sea
State/Province
Essex
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Local Institution
City
Newcastle upon Tyne
State/Province
Tyne and Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Facility Name
Local Institution
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://bms.com/studyconnect/Pages/home.aspx
Description
BMS Clinical Trial Patient Recruiting
Learn more about this trial
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)
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