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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03192969




Registration number
NCT03192969
Ethics application status
Date submitted
14/06/2017
Date registered
20/06/2017
Date last updated
12/07/2017

Titles & IDs
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
Secondary ID [1] 0 0
2016-002697-12
Secondary ID [2] 0 0
IM101-604
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Giant Cell Arteritis 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Other interventions - Placebo
Treatment: Drugs - Glucocorticoid Treatment

Experimental: Abatacept Combination Therapy - Abatacept subcutaneous injection (125 mg/mL prefilled syringe weekly) in combination with glucocorticoid therapy (up to 28-week taper of oral prednisone daily)

Placebo Comparator: Placebo Monotherapy- 28 Weeks - Glucocorticoid therapy (28-week taper of oral prednisone daily) in combination with placebo subcutaneous injection (1 mL pre-filled syringe weekly)

Placebo Comparator: Placebo Monotherapy- 52 Weeks - Glucocorticoid therapy (52 week taper of oral prednisone daily) in combination with subcutaneous placebo weekly


Treatment: Drugs: Abatacept
Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)

Other interventions: Placebo
Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes

Treatment: Drugs: Glucocorticoid Treatment
Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
40 weeks (week 12 to week 52)
Secondary outcome [1] 0 0
Physician's Global Assessment of Disease Activity according to visual analog scale (VAS) - measured by assessment parameters
Timepoint [1] 0 0
Up to 52 weeks
Secondary outcome [2] 0 0
Subject Assessment of Disease Activity according to visual analog scale (VAS) - measured by assessment parameters
Timepoint [2] 0 0
Up to 52 weeks
Secondary outcome [3] 0 0
Short Form questionnaire-36 (SF-36) - Patient reported outcome assessment
Timepoint [3] 0 0
Up to 52 weeks
Secondary outcome [4] 0 0
Time from Week 12 to first relapse after achieving remission - measured by investigator
Timepoint [4] 0 0
40 weeks (week 12 to week 52)
Secondary outcome [5] 0 0
Erythrocyte sedimentation rate (ESR) - Mean change from baseline.
Timepoint [5] 0 0
52 weeks
Secondary outcome [6] 0 0
C-reactive protein (CRP) - Mean change from baseline.
Timepoint [6] 0 0
52 weeks
Secondary outcome [7] 0 0
All adverse events and serious adverse events (AEs/SAEs) - measured by incidence of AEs and SAEs
Timepoint [7] 0 0
52 weeks
Secondary outcome [8] 0 0
Laboratory test abnormalities - measured by laboratory test parameters
Timepoint [8] 0 0
52 weeks
Secondary outcome [9] 0 0
Cmin (µg/mL): Trough level serum concentration of abatacept prior to the administration of the subcutaneous injection - measured by serum concentration
Timepoint [9] 0 0
104 weeks
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
52 weeks
Secondary outcome [11] 0 0
Cumulative glucocorticoid dose - measured as the total glucocorticoid dose used during the treatment period
Timepoint [11] 0 0
52 weeks
Secondary outcome [12] 0 0
EuroQOL 5 Dimensions (EQ-5D-3L) - Patient reported outcome assessment
Timepoint [12] 0 0
Up to 52 weeks
Secondary outcome [13] 0 0
Patient Reported Outcomes Measurement Information System (PROMIS)-Fatigue Short Form 8a - Patient reported outcome assessment
Timepoint [13] 0 0
Up to 52 weeks
Secondary outcome [14] 0 0
Resource Utilization - Assessed by the number of hospitalizations
Timepoint [14] 0 0
Up to 52 weeks

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



- 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
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Northmead
Recruitment hospital [2] 0 0
Local Institution - Auchenflower
Recruitment hospital [3] 0 0
Local Institution - Woodville South
Recruitment hospital [4] 0 0
Local Institution - Malvern East
Recruitment hospital [5] 0 0
Local Institution - Nedlands
Recruitment hospital [6] 0 0
Local Institution - Victoria Park
Recruitment postcode(s) [1] 0 0
2152 - Northmead
Recruitment postcode(s) [2] 0 0
4066 - Auchenflower
Recruitment postcode(s) [3] 0 0
5001 - Woodville South
Recruitment postcode(s) [4] 0 0
3145 - Malvern East
Recruitment postcode(s) [5] 0 0
6009 - Nedlands
Recruitment postcode(s) [6] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Iowa
Country [5] 0 0
United States of America
State/province [5] 0 0
Kansas
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
South Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
Austria
State/province [12] 0 0
Graz
Country [13] 0 0
Austria
State/province [13] 0 0
Stockerau
Country [14] 0 0
Belgium
State/province [14] 0 0
Leuven
Country [15] 0 0
Belgium
State/province [15] 0 0
Li?ge
Country [16] 0 0
Belgium
State/province [16] 0 0
Yvoir
Country [17] 0 0
Bulgaria
State/province [17] 0 0
Sofia-grad
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
Canada
State/province [20] 0 0
Saskatchewan
Country [21] 0 0
Denmark
State/province [21] 0 0
Aarhus C
Country [22] 0 0
Denmark
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Esbjerg
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Denmark
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Glostrup
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Denmark
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Holstebro
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Denmark
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Odense C
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Denmark
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Silkeborg
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Estonia
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Tallinn
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Estonia
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Tartu
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France
State/province [29] 0 0
Marseille
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France
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Nantes
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France
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Paris Cedex 14
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France
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Paris
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France
State/province [33] 0 0
Pau
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France
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Toulouse
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Germany
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Berlin
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Germany
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Dresden
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Germany
State/province [37] 0 0
Freiburg im Breisgau
Country [38] 0 0
Germany
State/province [38] 0 0
Hamburg
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Germany
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Hannover
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Germany
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Herne
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Germany
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Kirchheim
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Germany
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Rostock
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Germany
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Tubingen
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Germany
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W?rzburg
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Greece
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Athens
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Greece
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Larissa
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Greece
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Thessaloniki
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Ireland
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Dublin
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Italy
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Catania
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Italy
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Genova
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Italy
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Milano
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Italy
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Padova
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Italy
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Pavia
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Italy
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Prato
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Italy
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Torino
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Netherlands
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Almelo
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Netherlands
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Enschede
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Netherlands
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Groningen
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Helmond
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Netherlands
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Rotterdam
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Poland
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Bydgoszcz
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Poland
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Krakow
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Szczecin
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Warszawa
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Wroclaw
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Romania
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Cluj-Napoca
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Romania
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Sibiu
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Serbia
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Belgrade
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Spain
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Barcelona
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Spain
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Bilbao
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Spain
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L'Hospitalet de Llobregat
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Spain
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La Laguna
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Spain
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Madrid
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Spain
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Vitoria
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Sweden
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Stockholm
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Sweden
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Uppsala
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Sweden
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V?ster?s
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Switzerland
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Basel
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Switzerland
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Bern
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Switzerland
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Freiburg
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Switzerland
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St. Gallen
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Switzerland
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Z?rich
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United Kingdom
State/province [83] 0 0
Essex
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United Kingdom
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Tyne and Wear
Country [85] 0 0
United Kingdom
State/province [85] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03192969
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03192969