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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-002697-12 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Abatacept Combination Therapy | Experimental | Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily) |
|
| Placebo Monotherapy- 28 Weeks | Placebo Comparator | Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly) |
|
| Placebo Monotherapy- 52 Weeks | Placebo Comparator | Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Abatacept | Drug | Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 40 weeks (week 12 to week 52) |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's Global Assessment of Disease Activity according to visual analog scale (VAS) | measured by assessment parameters | Up to 52 weeks |
| Subject Assessment of Disease Activity according to visual analog scale (VAS) |
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol defined inclusion/exclusion criteria could apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Phoenix | Arizona | 85032 | United States | ||
| Local Institution |
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| Label | URL |
|---|---|
| BMS Clinical Trial Patient Recruiting | View source |
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| Placebo | Other | Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes |
|
| Glucocorticoid Treatment | Drug | Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone) |
|
measured by assessment parameters
| Up to 52 weeks |
| Short Form questionnaire-36 (SF-36) | Patient reported outcome assessment | Up to 52 weeks |
| Time from Week 12 to first relapse after achieving remission | measured by investigator | 40 weeks (week 12 to week 52) |
| Erythrocyte sedimentation rate (ESR) | Mean change from baseline. | 52 weeks |
| C-reactive protein (CRP) | Mean change from baseline. | 52 weeks |
| All adverse events and serious adverse events (AEs/SAEs) | measured by incidence of AEs and SAEs | 52 weeks |
| Laboratory test abnormalities | measured by laboratory test parameters | 52 weeks |
| Cmin (μg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection | measured by serum concentration | 104 weeks |
| 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. | 52 weeks |
| Cumulative glucocorticoid dose | measured as the total glucocorticoid dose used during the treatment period | 52 weeks |
| EuroQOL 5 Dimensions (EQ-5D-3L) | Patient reported outcome assessment | Up to 52 weeks |
| Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a | Patient reported outcome assessment | Up to 52 weeks |
| Resource Utilization | Assessed by the number of hospitalizations | Up to 52 weeks |
| Fullerton |
| California |
| 92835 |
| United States |
| Local Institution | West Hollywood | California | 90048 | United States |
| Local Institution | Denver | Colorado | 80230 | United States |
| Local Institution | Iowa City | Iowa | 52242 | United States |
| Local Institution | Kansas City | Kansas | 66160 | United States |
| Local Institution | Rochester | Minnesota | 55905-0001 | United States |
| Local Institution | New York | New York | 10021 | United States |
| Local Institution | Cleveland | Ohio | 44195 | United States |
| Local Institution | Dayton | Ohio | 45417 | United States |
| Local Institution | Philadelphia | Pennsylvania | 19104 | United States |
| Local Institution | Charleston | South Carolina | 29406 | United States |
| Local Institution | Beaumont | Texas | 77702 | United States |
| Local Institution | Northmead | New South Wales | 2152 | Australia |
| Local Institution | Auchenflower | Queensland | 4066 | Australia |
| Local Institution | Woodville South | South Australia | 5001 | Australia |
| Local Institution | Malvern East | Victoria | 3145 | Australia |
| Local Institution | Nedlands | Western Australia | 6009 | Australia |
| Local Institution | Victoria Park | Western Australia | 6100 | Australia |
| Local Institution | Graz | 8036 | Austria |
| Local Institution | Stockerau | 2000 | Austria |
| Local Institution | Leuven | 3000 | Belgium |
| Local Institution | Liège | 4000 | Belgium |
| Local Institution | Yvoir | 5530 | Belgium |
| Local Institution | Sofia | Sofia-Grad | 1606 | Bulgaria |
| Local Institution | Hamilton | Ontario | L8N 4A6 | Canada |
| Local Institution | Trois-Rivières | Quebec | G8Z 1Y2 | Canada |
| Local Institution | Saskatoon | Saskatchewan | S7K 0H6 | Canada |
| Local Institution | Aarhus C | 8000 | Denmark |
| Local Institution | Esbjerg | 6700 | Denmark |
| Local Institution | Glostrup Municipality | 2600 | Denmark |
| Local Institution | Holstebro | DK-7500 | Denmark |
| Local Institution | Odense C | 5000 | Denmark |
| Local Institution | Silkeborg | DK-8600 | Denmark |
| Local Institution | Tallinn | 11312 | Estonia |
| Local Institution | Tallinn | EE-13419 | Estonia |
| Local Institution | Tartu | 50107 | Estonia |
| Local Institution | Marseille | 13385 | France |
| Local Institution | Nantes | 44093 | France |
| Local Institution | Paris | 75018 | France |
| Local Institution | Paris | 75679 | France |
| Local Institution | Pau | 64000 | France |
| Local Institution | Toulouse | 31059 | France |
| Local Institution | Berlin | 13125 | Germany |
| Local Institution | Berlin | 14050 | Germany |
| Local Institution | Dresden | 01277 | Germany |
| Local Institution | Freiburg im Breisgau | 79095 | Germany |
| Local Institution | Hamburg | 22767 | Germany |
| Local Institution | Hanover | D30625 | Germany |
| Local Institution | Herne | 44652 | Germany |
| Local Institution | Kirchheim | 73230 | Germany |
| Local Institution | Rostock | 18059 | Germany |
| Local Institution | Tübingen | 72076 | Germany |
| Local Institution | W?rzburg | 97080 | Germany |
| Local Institution | Athens | 11527 | Greece |
| Local Institution | Larissa | 41110 | Greece |
| Local Institution | Thessaloniki | 56429 | Greece |
| Local Institution | Dublin | Ireland |
| Local Institution | Catania | 95124 | Italy |
| Local Institution | Genova | 16132 | Italy |
| Local Institution | Milan | 20121 | Italy |
| Local Institution | Milan | 20132 | Italy |
| Local Institution | Milan | 20157 | Italy |
| Local Institution | Padova | 35128 | Italy |
| Local Institution | Pavia | 27100 | Italy |
| Local Institution | Prato | 51900 | Italy |
| Local Institution | Torino | 10126 | Italy |
| Local Institution | Almelo | 7609 PP | Netherlands |
| Local Institution | Enschede | 7513 ER | Netherlands |
| Local Institution | Groningen | 9713 GZ | Netherlands |
| Local Institution | Helmond | 5707 HA | Netherlands |
| Local Institution | Rotterdam | 3059XN | Netherlands |
| Local Institution | Bydgoszcz | 85-168 | Poland |
| Local Institution | Krakow | 31-501 | Poland |
| Local Institution | Szczecin | 71-252 | Poland |
| Local Institution | Warsaw | 02-637 | Poland |
| Local Institution | Wroclaw | 52-416 | Poland |
| Local Institution | Cluj-Napoca | 400006 | Romania |
| Local Institution | Sibiu | 550245 | Romania |
| Local Institution | Belgrade | 11000 | Serbia |
| Local Institution | Barcelona | 08025 | Spain |
| Local Institution | Bilbao | 48013 | Spain |
| Local Institution | L'Hospitalet de Llobregat | 08907 | Spain |
| Local Institution | Madrid | 28007 | Spain |
| Local Institution | Madrid | 28034 | Spain |
| Local Institution | Madrid | 28040 | Spain |
| Local Institution | San Cristóbal de La Laguna | 38320 | Spain |
| Local Institution | Vitoria-Gasteiz | 01009 | Spain |
| Local Institution | Stockholm | SE-18288 | Sweden |
| Local Institution | Uppsala | 755 92 | Sweden |
| Local Institution | V?ster?s | 72189 | Sweden |
| Local Institution | Basel | 4031 | Switzerland |
| Local Institution | Bern | 3010 | Switzerland |
| Local Institution | Fribourg | 1708 | Switzerland |
| Local Institution | Sankt Gallen | 9007 | Switzerland |
| Local Institution | Z?rich | 8091 | Switzerland |
| Local Institution | Westcliff-on-Sea | Essex | SS0 0RY | United Kingdom |
| Local Institution | Newcastle upon Tyne | Tyne and Wear | NE7 7DN | United Kingdom |
| Local Institution | London | E1 1BB | United Kingdom |
| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069594 | Abatacept |
| ID | Term |
|---|---|
| D018796 | Immunoconjugates |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D012712 | Serum Globulins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D005916 | Globulins |
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