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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00534313
Registration number
NCT00534313
Ethics application status
Date submitted
20/09/2007
Date registered
24/09/2007
Date last updated
1/08/2012
Titles & IDs
Public title
Safety and Efficacy of Abatacept Versus Placebo in Participants With Psoriatic Arthritis
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Scientific title
A Phase IIB, Multi-Dose, Multi-center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis
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Secondary ID [1]
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EUDRACT 2007-004241-15
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Secondary ID [2]
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IM101-158
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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0
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Rheumatoid arthritis
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Inflammatory and Immune System
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0
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Abatacept
Treatment: Drugs - Placebo
Active Comparator: Abatacept (30/10) - Abatacept (30 mg/kg) was administered as intravenous (iv) infusion over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants for dosing on Days 1 and 15 followed by fixed dosing as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg) thereafter.
Active Comparator: Abatacept (10/10) - Abatacept (10 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 in the double-blind period and continued for next 18 months in the open-label period till Day 729. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
Active Comparator: Abatacept (3/3) - Abatacept (3 mg/kg) was administered as iv infusion over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. The dose was calculated based on screening visit weight of participants.
Placebo Comparator: Placebo - Placebo solution (5% dextrose in water for injection, 0.9% sodium chloride injection) by iv infusion was administered on Days 1, 15, and 29 and every 28 days thereafter till Day 141.
Treatment: Drugs: Abatacept
Solution, intravenous, monthly, short-term = 24 weeks (6 months)
Treatment: Drugs: Placebo
Solution, intravenous, placebo (double dummy), monthly, short-term = 24 weeks (6 months)
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Long-term Period: Number of Participants With Death As Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, SAEs Leading to Discontinuation, Adverse Events (AEs), Drug-related AEs, AEs Leading to Discontinuation, and AEs of Interest
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Assessment method [1]
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Presp=prespecified; acute= =1 hour after start of infusion; periinfusional= =24 hours after start of infusion. AE=any new unfavorable symptom or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=an unfavorable medical event that at any dose results in death, significant disability, drug dependency/abuse, hospitalization or prolonged hospitalization; is life-threatening, an important medical event, or a congenital anomaly/birth defect. Drug-related=possibly, probably, or certainly related and of unknown relationship to study drug.
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Timepoint [1]
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From Day 169 to Day 729
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Primary outcome [2]
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Short-term Period: Number of Participants With ACR 20 Response at Day 169
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Assessment method [2]
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An ACR 20 responder was a participant who had a reduction of 20% or more from baseline in scores for both tender and swollen joints and had a reduction from baseline of 20% or more in 3 out of the following 5 assessments: participant's assessment of disease activity, participant's global assessment of disease activity, investigator's global assessment of disease activity, participant's assessment of physical function by HAQ-DI, and Disease Activity Score 28-C reactive protein.
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Timepoint [2]
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At Day 169 from Baseline
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Secondary outcome [1]
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Long-term Period: Percentage of Participants Achieving American College of Rheumatology (ACR) 20, ACR 50, ACR 70, ACR 90 Responses at Days 365 and 729
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Assessment method [1]
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An ACR 20 (50, 70, 90) responder was a participant whose counts for both tender and swollen joints was reduced by 20% (50%, 70%, 90%, respectively) or more from baseline and who had a reduction of 20% (50%, 70%, 90%, respectively) or more from baseline in 3 of the following assessments: participant's assessment of disease activity, participant's global assessment of disease activity, Investigators Global Response, participant's assessment of physical function by Health Assessment Questionnaire Disability Index, and Disease Activity Score 28 based on C-reactive protein.
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Timepoint [1]
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At Days 365 and 729 from Baseline
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Secondary outcome [2]
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Long-term Period: Number of Participants With an Investigators Global Assessment (IGA) Score of Clear or Almost Clear at Days 365 and 729
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Assessment method [2]
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IGA score indicates lesion induration, scaling, and erythema: 0=clear (no signs of plaque psoriasis except for residual discoloration); 1=almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2=mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3=moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
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Timepoint [2]
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From Day 169 to Days 365 and 729
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Secondary outcome [3]
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Long-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Days 365 and 729
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Assessment method [3]
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Target lesion score is a measurement of the degree of erythema, induration, and scale of a psoriatic lesion, at least 2 cm in diameter, selected as a target for response throughout the study period. The scores assigned were 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
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Timepoint [3]
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From Baseline to Days 365 and 729
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Secondary outcome [4]
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Long-term Period: Mean Change From Baseline in the Short-form 36 (SF-36), Version 2, Domain and Component Scores at Days 365 and 729
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Assessment method [4]
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PCS=physical component score; MCS=mental component score. The SF-36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
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Timepoint [4]
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At Days 365 and 729 from baseline
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Secondary outcome [5]
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Long-term Period: Number of Participants Achieving A Reduction of At Least 0.3 Unit From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Days 365 and 729
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Assessment method [5]
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Per the HAQ-DI, participants assessed their own ability to perform the following tasks: dress/groom, arise, eat, walk, reach, grip, maintain hygiene, and maintain daily activity over a period by marking their responses on a questionnaire. Scoring of the HAQ-DI: 0=without any difficulty; 1=with some difficulty; 2=with much difficulty); and 3=unable to do. Greater score=greater disability. Responders with a >= 0.3 unit decrease in index scores from baseline to days 365 and 729 were considered to be improved.
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Timepoint [5]
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Days 365 and 729 from baseline
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Secondary outcome [6]
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Short-term Period: Number of Participants With Marked Abnormalities in Hematology
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Assessment method [6]
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LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormalities are laboratory measurements marked as abnormal, per predefined study criteria, at any study time point. Criteria: Hemoglobin >3 g/dL decrease from pre-Rx value; hematocrit <0.75*pre-Rx value; erythrocytes <0.75*pre-Rx value; platelets <0.67*LLN (or, if pre-Rx value <LLN, <0.5*pre-Rx value and <100000/mm^3) or >1.5*ULN.
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Timepoint [6]
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From Baseline to Day 169
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Secondary outcome [7]
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Short-term Period: Number of Participants With Marked Abnormalities in Hematology (Continued)
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Assessment method [7]
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LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Laboratory measurements are marked as abnormal per predefined study criteria, at any study time point. Criteria for the data presented. Leukocytes <0.75*LLN or >1.25*ULN (or, if pre-Rx value <LLN, <0.8*pre-Rx or >ULN. If pre-Rx value >ULN, >1.2*pre-Rx or <LLN); neutrophils+bands (absolute) <1.00*10^3 c/uL; lymphocytes (absolute) <0.75*10^3 c/uL or >7.50*10^3 c/uL; monocytes (absolute) >2000/mm^3; basophils (absolute) >0.40*10^3 c/uL; eosinophils (absolute) >0.75*10^3 c/uL.
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Timepoint [7]
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From Baseline to Day 169
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Secondary outcome [8]
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Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry
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Assessment method [8]
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ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Alkaline phosphatase (ALP), gamma-glutamyltransferase (GGT) >2*ULN (if pre-Rx >ULN, >3*pre-Rx); aspartate aminotransferase (AST), alanine transaminase (ALT) >3*ULN (if pre-Rx >ULN, >4*pre-Rx); bilirubin (total) >2*ULN (if pre-Rx >ULN, >4*pre-Rx); blood urea nitrogen (BUN) >2*pre-Rx; creatinine >1.5*pre-Rx.
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Timepoint [8]
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Baseline to Day 169
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Secondary outcome [9]
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Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
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Assessment method [9]
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LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Sodium <0.95*LLN or >1.05*ULN (if pre-Rx<LLN, <0.95*pre-Rx or >ULN. If pre-Rx >ULN,>1.05* pre-Rx or <LLN); potassium, chloride <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN); calcium <0.8*LLN or >1.2*ULN (if pre-Rx <LLN,<0.75* pre-Rx or >ULN. If pre-Rx >ULN, >1.25* pre-Rx or <LLN); phosphorous <0.75*LLN or >1.25*ULN (if pre-Rx <LLN, <0.67*pre-Rx or >ULN. If pre-Rx >ULN, >1.33*pre-Rx or <LLN.
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Timepoint [9]
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Baseline to Day 169
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Secondary outcome [10]
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Short-term Period: Number of Participants With Marked Abnormalities in Serum Chemistry (Continued)
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Assessment method [10]
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LLN=lower limit of normal; ULN=upper limit of normal; pre-Rx=pretreatment. Marked abnormality criteria: Glucose <65 or >220 mg/dL; glucose (fasting)<0.8*LLN or >1.5*ULN (if pre-Rx <LLN, <0.8*pre-Rx or >ULN. If pre-Rx >ULN, t>2.0*pre-Rx or <LLN). Protein (total) <0.9*LLN or >1.1*ULN (if pre-Rx <LLN, <0.9*pre-Rx or >ULN. If pre-Rx >ULN, >1.1*pre-Rx or <LLN). Albumin <0.9*LLN (if pre-Rx <LLN, <0.75* pre-Rx). Uric acid >1.5*ULN; if pre-Rx >ULN or >2*pre-Rx value.
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Timepoint [10]
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From Baseline to Day 169
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Secondary outcome [11]
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Short-term Period: Number of Participants With Marked Abnormalities in Urinalysis
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Assessment method [11]
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Pre-Rx=pretreatment. Criteria for marked abnormality: Protein, glucose, blood, leukocyte esterase, red blood cells (RBC), white blood cells (WBC) >=2+ (or, if value >=4, or if pre-Rx value=0 or 0.5, >= 2* or if pre-RX value =1, >=3, or if pre-Rx =2 or 3, >=4).
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Timepoint [11]
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From Baseline to Day 169
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Secondary outcome [12]
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Short-term Period: Number of Participants Who Died and With SAEs, AEs, AEs Leading to Discontinuation, SAEs Leading to Discontinuation, Drug-related AEs, and Drug-related SAEs
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Assessment method [12]
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An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment. An SAE is any unfavorable medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency or abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related=possibly, probably, or certainly related to and of unknown relationship to study treatment.
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Timepoint [12]
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From Baseline to Day 169
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Secondary outcome [13]
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Short-term Period: Number of Participants With an IGA Score of Clear or Almost Clear at Day 169
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Assessment method [13]
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Score indicates lesion induration, scaling, and erythema: 0 = clear (no signs of plaque psoriasis except for residual discoloration); 1 = almost clear (just perceptible erythema, no induration to very slightly elevated above normal skin levels, limited amount of very fine scaling); 2 = mild disease (mild erythema, mild induration, mainly fine scaling predominates); 3 = moderate disease (moderate erythema [most plaques are red], moderate induration and/or coarse scale predominates); 4=severe (severe erythema, marked to very marked elevation of lesions, coarse thick scale predominates).
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Timepoint [13]
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At Day 169 from Baseline
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Secondary outcome [14]
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Short-term Period: Mean Percentage of Change From Baseline in Target Lesion Score at Day 169
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Assessment method [14]
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Target lesion score measures the degree of erythema, induration, and scale of a psoriatic lesion with a diameter of at least 2 cm, selected as a target for response throughout the study period. Scores: 0=clear, 1=almost clear, 2=mild clear, 3=moderate disease, 4=severe. Percent improvement from baseline was computed using the ratio of improvement from baseline to the baseline value.
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Timepoint [14]
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At Day 169 from Baseline
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Secondary outcome [15]
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Short-term Period: Number of Participants With Positive Responses for Serum Levels of Abatacept-specific Antibodies (Anti-Abatacept-C)
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Assessment method [15]
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Meso Scale Discovery electrochemiluminescence, a validated, sensitive immunoassay technique (anti-abatacept assay C) was used to measure serum levels of abatacept-specific antibodies against the whole molecule (both the CTLA4 and possibly immunoglobulin G portion [anti-abatacept antibody].
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Timepoint [15]
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From Baseline to Day 169
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Secondary outcome [16]
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Short-term Period: Mean Change From Baseline in the Mental Component Summary Score as Measured by the Short-form 36 at Day 169
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Assessment method [16]
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PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
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Timepoint [16]
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At Day 169 from Baseline
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Secondary outcome [17]
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Short-term Period: Mean Serum Concentrations of Abatacept
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Assessment method [17]
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Abatacept was assayed using a validated enzyme linked immunosorbent assay method (ELISA). Serum concentration versus time data was analyzed in the descriptive pharmacokinetic (PK) analysis.
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Timepoint [17]
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Days 1, 15, 29, 57, 85, 113, 141, and 169
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Secondary outcome [18]
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Short-term Period: Mean Serum Trough Concentrations (Cmin) of Abatacept
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Assessment method [18]
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Abatacept was assayed using a validated ELISA method. Cmin of abatacept was obtained from concentration versus time data.
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Timepoint [18]
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Days 1, 15, 29, 57, 85, 113, 141, and 169
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Secondary outcome [19]
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Short-term Period: Population Pharmacokinetic (POPPK) Analysis of the Pharmacokinetic (PK) Parameters
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Assessment method [19]
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PK data: summaries of concentrations and concentration versus time plots were obtained. These data were to be used to develop a POPPK model using a nonlinear mixed-effects model. Prediction of PK data for each of the 3 abatacept treatment groups using POPPK methodology was not performed, because it would not provide any relevant information over the observed PK data.
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Timepoint [19]
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Days 1, 15, 29, 57, 85, 113, 141, and 169
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Secondary outcome [20]
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Short-term Period: Mean Change From Baseline in Physical Component Summary Score as Measured by the Short-form 36 at Day 169
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Assessment method [20]
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PCS=physical component score; MCS=mental component score. The Short-form 36 is a 36-item instrument with physical and mental components and covers quality of life (QoL) domains: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Responses are used to derive physical and mental component summary scores, ranging from 0 to 100, with higher scores indicating better QoL. Mean change from baseline=postbaseline value-baseline value; a higher value signifies improvement.
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Timepoint [20]
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At Day 169 from Baseline
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Secondary outcome [21]
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Short-term Period: Number of Participants Achieving a Reduction of At Least 0.3 Unit From Baseline in HAQ-DI Scores at Day 169
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Assessment method [21]
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The HAQ-DI assesses a participant's ability to perform the following tasks: dress/groom; arise; eat; walk; reach; grip; maintain hygiene; and maintain daily activity over a period by marking their response on a questionnaire. Responses/scores range from: 0=without any difficulty, 1=with some difficulty, 2=with much difficulty, 3=to unable to do. Higher total score=greater disability.
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Timepoint [21]
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At Day 169 from Baseline
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Eligibility
Key inclusion criteria
Key
- Meeting classification criteria for psoriatic arthritis for a duration of disease of
at least 3 months
- Prior failure (inefficacy or intolerance) of therapy with disease-modifying
antirheumatic drugs; if patient had prior failure of methotrexate, he or she must have
been taking at least 15 mg per week for at least 2 months
- If recent failure(inefficacy or intolerance) of a tumor necrosis factor a-blockade
compound, participant must be washed out prior to first dose: 56 days for infliximab
and 28 days for etanercept and adalimumab
- Disease activity as defined by a tender joint count of =3, swollen joint count of =3,
and clinically detectable synovitis at screening and Day 01 (prior to infusion)
- Active psoriasis with a qualifying target lesion =2 cm in diameter
- Able to undergo magnetic resonance imaging
- Use of appropriate birth control by women of child bearing potential (WOCBP)
Key
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
the entire study period and for up to 10 weeks after the last dose of investigational
product
- Women who are pregnant or breastfeeding or who plan to become pregnant or to start
breastfeeding during the duration of the study
- Women with a positive pregnancy test on enrollment or prior to investigational product
administration.
- Participants scheduled for or anticipating joint replacement surgery.
- Those with a recent history of clinically significant drug or alcohol abuse
- Concomitant illness that in the investigator's opinion is likely to require systemic
glucocorticosteroid therapy during the study (for example: moderate to severe asthma)
- Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic,
pulmonary, cardiac, neurologic, ophthalmologic, or cerebral disease.
- Unwillingness or inability to undergo screening based on current local or country
guidelines/standards to evaluate the presence of cancer
- Cancer within the last 5 years
- Current malignancy or signs of possible malignancy detected by screening procedures
for which the workup to exclude malignancy has not been completed or malignancy cannot
be excluded
- At risk for or history (within 3 years) of tuberculosis
- Any serious bacterial infection within the last 3 months, not treated and resolved
with antibiotics, or any chronic bacterial infection (such as, but not limited to,
chronic pyelonephritis, osteomyelitis, and bronchiectasis)
- Evidence of active or latent bacterial or viral infection infections at the time of
potential enrollment
- Herpes zoster or cytomegalovirus resolving less than 2 months prior to signing
informed consent
- Receipt of any live vaccines within 3 months of the anticipated first dose of study
medication or anticipation of the need for a live vaccine at any time during and for 3
months after the duration of the study
Long-term period participants: Must have met eligibility criteria for short-term period and
completed short-term (24-week) period of the study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2007
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/05/2011
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Sample size
Target
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Accrual to date
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Final
191
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
0
0
Local Institution - Cairns
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Recruitment hospital [2]
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0
Local Institution - Maroochydore
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Recruitment hospital [3]
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0
Local Institution - Fitzroy, Melbourne
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Recruitment postcode(s) [1]
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0
4872 - Cairns
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Recruitment postcode(s) [2]
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0
4558 - Maroochydore
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Recruitment postcode(s) [3]
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3065 - Fitzroy, Melbourne
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
California
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Country [3]
0
0
United States of America
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State/province [3]
0
0
Connecticut
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Massachusetts
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Michigan
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Minnesota
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Country [8]
0
0
United States of America
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State/province [8]
0
0
North Carolina
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Ohio
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Oklahoma
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Pennsylvania
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Texas
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Washington
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Country [14]
0
0
Argentina
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State/province [14]
0
0
Buenos Aires
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Country [15]
0
0
Argentina
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State/province [15]
0
0
Santa Fe
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Country [16]
0
0
Belgium
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State/province [16]
0
0
Hasselt
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Country [17]
0
0
Belgium
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State/province [17]
0
0
Leuven
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Country [18]
0
0
Canada
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State/province [18]
0
0
Newfoundland and Labrador
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Country [19]
0
0
Canada
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State/province [19]
0
0
Quebec
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Country [20]
0
0
France
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State/province [20]
0
0
Chambray Les Tours
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Country [21]
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France
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State/province [21]
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Lille
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France
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Montpellier Cedex 5
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Country [23]
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Germany
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Frankfurt/Main
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Germany
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Hamburg
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Germany
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Hildesheim
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Italy
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Napoli
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Italy
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Potenza
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Italy
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Reggio Emilia
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Netherlands
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Amsterdam
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Norway
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Lillehammer
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South Africa
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Western Cape
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Spain
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A Coruna
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Bristol-Myers Squibb
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Ethics approval
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Summary
Brief summary
The purpose of this study is to determine an optimal abatacept dosing regimen for the
treatment of active arthritis due to psoriatic arthritis in patients who have had a prior
inadequate response to disease-modifying antirheumatic drugs, including methotrexate and
tumor necrosis factor alpha-blockade compounds.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00534313
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Bristol-Myers Squibb
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00534313
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