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Methotrexate-Inadequate Response Autoinjector Device Sub Study (MTX-IR)

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ClinicalTrials.gov Identifier: NCT01844895
Recruitment Status : Completed
First Posted : May 3, 2013
Results First Posted : July 1, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Drug: Abatacept
Enrollment 120
Recruitment Details Autoinjector Substudy initiated April 2013; completed July 2014. Those participating in the long term main (parent) study IM101-174 who received weekly open-label SC 125mg abatacept injections via prefilled syringe for at least 3 months and who did not participate in a previous device substudy were eligible to enroll in the autoinjector substudy.
Pre-assignment Details  
Arm/Group Title 125 mg Abatacept (Autoinjector and Prefilled Syringe)
Hide Arm/Group Description 125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
Period Title: Day 1 to Day 28 - Pre-filled Syringe
Started 120
Completed 117
Not Completed 3
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Clinic Closed             1
Period Title: Day 29 - Day113 - Autoinjector
Started 117
Completed 111
Not Completed 6
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Difficulty using device             3
planned surgery             1
Arm/Group Title 125 mg Abatacept (Autoinjector and Prefilled Syringe)
Hide Arm/Group Description Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
Overall Number of Baseline Participants 117
Hide Baseline Analysis Population Description
The Treated Analysis population included all enrolled participants who received at least 1 dose of study medication administered with the autoinjector during the substudy period.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 117 participants
53.9  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 117 participants
Female
100
  85.5%
Male
17
  14.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
South America 100
North America 17
Body Weight  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 117 participants
<60 kilogram (kg) 28
60 - 100 kg 83
>100 kg 6
Duration of Disease  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 117 participants
6.0
(0 to 41.0)
Methotrexate (MTX) Dose at SubStudy Baseline   [1] 
Mean (Standard Deviation)
Unit of measure:  Mg/wk
Number Analyzed 117 participants
17.0  (6.0)
[1]
Measure Description: Substudy baseline=Day 1 of Substudy. MTX dose is measured in milligrams per week (mg/wk).
1.Primary Outcome
Title Pharmacokinetic (PK) Analysis: Adjusted Geometric Mean Observed Serum Trough Concentration at Steady State (Cminss) of Abatacept Using a Prefilled Syringe (Measured on Day 29) and Using an Autoinjector (Measured on Day 113)
Hide Description Abatacept SC was self-administered with a prefilled syringe every 7 days for the first 4 weeks until Day 29; Blood samples for PK were taken pre-dose (0 hour) on Days 29 and 113. Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL). Adjusted geometric mean and 90% confidence interval (CI) are presented.
Time Frame Day 29, Day 113
Hide Outcome Measure Data
Hide Analysis Population Description
The primary PK analysis population is a subset of the Treated Analysis population with (1) viable Cmin data on both substudy Days 29 and 113 (2) no missed Abatacept dose during the substudy period.
Arm/Group Title 125 mg Abatacept SC Using Prefilled Syringe - Day 29 125 mg Abatacept SC Using Autoinjector - Day 113
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
Overall Number of Participants Analyzed 88 88
Geometric Mean (90% Confidence Interval)
Unit of Measure: μg/mL
27.76
(24.44 to 31.53)
25.32
(22.59 to 28.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 125 mg Abatacept SC Using Prefilled Syringe - Day 29, 125 mg Abatacept SC Using Autoinjector - Day 113
Comments A mixed-effect model of log (Cminss) with device and substudy baseline weight category (< 60 kg,60-100 kg, > 100 kg) as fixed effects and participant as a random effect was used. Point estimates and 90% CIs for device differences on the log scale were exponentiated to obtain estimates for ratios of geometric means on the original scale. No adjustment was made for multiplicity. PK comparability was concluded if the 90% CIs for the ratios of geometric means were contained within 80% to 125%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter geometric mean ratio
Estimated Value 0.91
Confidence Interval (2-Sided) 90%
0.83 to 1.00
Estimation Comments [Not Specified]
2.Secondary Outcome
Title PK Analysis: Geometric Mean of Maximum Observed Serum Concentration (Cmax) of Abatacept During the Sampling Period Between Substudy Days 22 and 29 for the Prefilled Syringe and Between Substudy Days 106 and Day 113 for the Autoinjector
Hide Description Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Cmax was measured in μg/mL.
Time Frame Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Arm/Group Title 125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29 125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
Overall Number of Participants Analyzed 95 78
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
40.9
(48%)
39.8
(58%)
3.Secondary Outcome
Title PK Analysis: Median Time to Achieve Cmax (Tmax) During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector
Hide Description Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Tmax was measured in hours (h).
Time Frame Days 22, 24, 25, 26, 29 (prefilled syringe); Days 106, 108, 109, 110,113 (autoinjector)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Arm/Group Title 125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29 125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
Overall Number of Participants Analyzed 95 78
Median (Full Range)
Unit of Measure: h
70.00
(0 to 168.7)
56.34
(0 to 171.1)
4.Secondary Outcome
Title Geometric Mean of Area Under Serum Concentration-time (AUC) During a Dosing Interval (TAU) of Abatacept During the Sampling Period Between Days 22 and 29 for the Prefilled Syringe and Between Days 106 and Day 113 for the Autoinjector
Hide Description Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken on Days 1 and 22 at 0 hour (predose), Day 24 at 48 hour (h) post dose, Day 25 at 72 h post dose, Day 26 at 96 h post dose and Day 29 at 0 h (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy; Blood samples for PK were taken on Day 106 at 0 h (predose), Day 108 at 48 h post dose, Day 109 at 72 h post dose, Day 110 at 96 h post dose and at Day 113 0h (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. AUC(TAU) where TAU = 168 hours was calculated in µg*h/mL
Time Frame Days 22, 24, 25, 26,29 (prefilled syringe); Days 106, 108, 109, 110, 113 (autoinjector)
Hide Outcome Measure Data
Hide Analysis Population Description
PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector. Participants did not miss either 0-hour or 168-hour samples and not missed 2 or more time points in the PK profile.
Arm/Group Title 125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29 125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
Overall Number of Participants Analyzed 95 78
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: µg*h/mL
5740
(47%)
5643
(50%)
5.Secondary Outcome
Title Geometric Mean of Trough Serum Concentration (Cmin) Over Time and During the Switch From Prefilled Syringe to Autoinjector on Days 22, 29, 57, 85, 106, and 113
Hide Description Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29; Blood samples for PK were taken at 0 hour (predose). On substudy Day 29, participants were switched from the prefilled syringe to the autoinjector. Participants continued to self-administer abatacept with the autoinjector every 7 days following Day 29 for the remaining 3 months of the substudy. Blood samples for PK were taken at 0 hour (predose). Serum concentrations of abatacept were analyzed using a validated ELISA. Steady-state trough observed concentration in serum (Cminss) was measured in micrograms/milliliter (μg/mL).
Time Frame Days 22, 29, 57, 85, 106, and 113
Hide Outcome Measure Data
Hide Analysis Population Description
PK population: A subset of the treated population with at least 1 PK sample collected/assessed for serum concentration after start of autoinjector and with Cmin obtained appropriately (7 days + or -3 days after the previous dose).
Arm/Group Title 125 mg Abatacept SC Using Prefilled Syringe 125 mg Abatacept SC Using Autoinjector
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
Overall Number of Participants Analyzed 108 105
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: μg/mL
Day 22 (n=104, 0) Pre-filled Syringe Only
29.09
(48%)
NA [1] 
(NA%)
Day 29 (n=108, 0) Pre-filled Syringe Only
30.58
(51%)
NA [1] 
(NA%)
Day 57 (n=0,105) Autoinjector Only
NA [2] 
(NA%)
28.79
(59%)
Day 85 (n=0,104) Autoinjector Only
NA [2] 
(NA%)
25.73
(53%)
Day 106 (n=0, 91) Autoinjector Only
NA [2] 
(NA%)
30.42
(56%)
Day 113 (n=0,100) Autoinjector Only
NA [2] 
(NA%)
28.06
(51%)
[1]
n=0 for autoinjector on Days 22 and 29
[2]
n=0 for prefilled syringe after Day 29
6.Secondary Outcome
Title Number of Participants With Positive Anti-Abatacept or Anti-CTLA4 Antibody Responses by Electrochemiluminescence (ECL) on Day 29 and Day 113.
Hide Description Serum samples for immunogenicity were evaluated for presence of anti-abatacept antibodies using a validated bridging ECL on Day 29 and Day 113. The ECL assay differentiated between 2 antibody specificities: the immunoglobulin (Ig) G and/or junction region and cytotoxic leukocyte antigen 4 (CTLA4) and possibly Ig. A positive immunogenicity response relative to baseline was defined as: A missing baseline immunogenicity measurement and a positive analytical laboratory reported immunogenicity response post-baseline; A negative baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline; A positive baseline immunogenicity response and a positive analytical laboratory reported immunogenicity response post-baseline that has a titer value strictly greater than the baseline titer value.
Time Frame Days 29 and 113
Hide Outcome Measure Data
Hide Analysis Population Description
A subset of the treated analysis population for whom at least 1 immunogenicity sample was collected and assessed for serum anti-abatacept antibodies, were summarized.
Arm/Group Title 125 mg Abatacept SC Prefilled Syringe - Day 29 125 mg Abatacept SC Autoinjector- Day 113
Hide Arm/Group Description:
125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
Overall Number of Participants Analyzed 115 103
Measure Type: Number
Unit of Measure: participants
CTLA4 and Possibly Ig 1 1
Ig and/or Junction 5 2
Time Frame Day 1 of the substudy up to 56 days post the last autoinjector dose.
Adverse Event Reporting Description Substudy was approximately 4 months in length. Participants on Day 1 up to Day 29 used prefilled syringes to self administer study drug and then starting Day 29 and for 3 additional months, participants used an autoinjector to self administer study drug.
 
Arm/Group Title Abatacept Via Autoinjector Only (Day 29 to End of Study) Abatacept Cumulative (Prefilled Syringe and Autoinjector)
Hide Arm/Group Description Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy. 125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
All-Cause Mortality
Abatacept Via Autoinjector Only (Day 29 to End of Study) Abatacept Cumulative (Prefilled Syringe and Autoinjector)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Abatacept Via Autoinjector Only (Day 29 to End of Study) Abatacept Cumulative (Prefilled Syringe and Autoinjector)
Affected / at Risk (%) Affected / at Risk (%)
Total   3/117 (2.56%)   3/117 (2.56%) 
Cardiac disorders     
Myocardial Ischemia * 1  1/117 (0.85%)  1/117 (0.85%) 
Infections and infestations     
HiNI Influenza * 1  1/117 (0.85%)  1/117 (0.85%) 
Postoperative wound infection * 1  1/117 (0.85%)  1/117 (0.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Abatacept Via Autoinjector Only (Day 29 to End of Study) Abatacept Cumulative (Prefilled Syringe and Autoinjector)
Affected / at Risk (%) Affected / at Risk (%)
Total   40/117 (34.19%)   43/117 (36.75%) 
Cardiac disorders     
Tachycardia * 1  1/117 (0.85%)  1/117 (0.85%) 
Ear and labyrinth disorders     
Tinnitus * 1  1/117 (0.85%)  1/117 (0.85%) 
Gastrointestinal disorders     
Abdominal Distension * 1  0/117 (0.00%)  1/117 (0.85%) 
Abdominal Pain * 1  1/117 (0.85%)  1/117 (0.85%) 
Gastritis * 1  1/117 (0.85%)  1/117 (0.85%) 
Irritable Bowel syndrome * 1  0/117 (0.00%)  1/117 (0.85%) 
General disorders     
Drug intolerance * 1  0/117 (0.00%)  1/117 (0.85%) 
Injection site Hemorrhage * 1  1/117 (0.85%)  1/117 (0.85%) 
Injection site pruritus * 1  1/117 (0.85%)  1/117 (0.85%) 
Immune system disorders     
Drug Hypersensitivity * 1  1/117 (0.85%)  1/117 (0.85%) 
Seasonal Allergy * 1  1/117 (0.85%)  1/117 (0.85%) 
Infections and infestations     
Nasopharyngitis * 1  7/117 (5.98%)  9/117 (7.69%) 
Pharyngitis * 1  5/117 (4.27%)  5/117 (4.27%) 
Upper Respiratory Tract Infection * 1  5/117 (4.27%)  6/117 (5.13%) 
Bronchitis * 1  2/117 (1.71%)  3/117 (2.56%) 
Urinary Tract Infection * 1  1/117 (0.85%)  2/117 (1.71%) 
Conjunctivitis * 1  1/117 (0.85%)  1/117 (0.85%) 
Ear Infection * 1  1/117 (0.85%)  1/117 (0.85%) 
Folliculitis * 1  1/117 (0.85%)  1/117 (0.85%) 
Impetigo * 1  1/117 (0.85%)  1/117 (0.85%) 
Pharyngitis Bacterial * 1  1/117 (0.85%)  1/117 (0.85%) 
Post Procedural Infection * 1  1/117 (0.85%)  1/117 (0.85%) 
Sinusitis * 1  1/117 (0.85%)  1/117 (0.85%) 
Upper Respiratory Tract Infection Bacterial * 1  1/117 (0.85%)  1/117 (0.85%) 
Vaginal Infection * 1  1/117 (0.85%)  1/117 (0.85%) 
Injury, poisoning and procedural complications     
Contusion * 1  0/117 (0.00%)  1/117 (0.85%) 
Investigations     
Alanine Aminotransferase Increased * 1  1/117 (0.85%)  1/117 (0.85%) 
Blood Pressure Increased * 1  0/117 (0.00%)  1/117 (0.85%) 
Transaminases Increased * 1  1/117 (0.85%)  1/117 (0.85%) 
Musculoskeletal and connective tissue disorders     
Bursitis * 1  1/117 (0.85%)  3/117 (2.56%) 
Back Pain * 1  1/117 (0.85%)  2/117 (1.71%) 
Fibromyalgia * 1  1/117 (0.85%)  1/117 (0.85%) 
Musculoskeletal Pain * 1  1/117 (0.85%)  1/117 (0.85%) 
Plantar Fascitis * 1  0/117 (0.00%)  1/117 (0.85%) 
Nervous system disorders     
Cervical Radiculopathy * 1  1/117 (0.85%)  1/117 (0.85%) 
Dizziness * 1  1/117 (0.85%)  1/117 (0.85%) 
Headache * 1  1/117 (0.85%)  1/117 (0.85%) 
Reproductive system and breast disorders     
Postmenopausal hemorrhage * 1  1/117 (0.85%)  1/117 (0.85%) 
Respiratory, thoracic and mediastinal disorders     
Asthma * 1  1/117 (0.85%)  1/117 (0.85%) 
Skin and subcutaneous tissue disorders     
Actinic Keratosis * 1  1/117 (0.85%)  1/117 (0.85%) 
Dermatitis contact * 1  1/117 (0.85%)  1/117 (0.85%) 
Intertrigo * 1  1/117 (0.85%)  1/117 (0.85%) 
Neurodermatitis * 1  1/117 (0.85%)  1/117 (0.85%) 
Vascular disorders     
Hypertension * 1  2/117 (1.71%)  2/117 (1.71%) 
Hypotension * 1  1/117 (0.85%)  1/117 (0.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 17.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Bristol-Myers Squibb Study Director
Organization: Bristol-Myers Squibb
EMail: Clinical.Trials@bms.com
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01844895     History of Changes
Other Study ID Numbers: IM101-174 Substudy-2
2007-005434-37 ( EudraCT Number )
First Submitted: April 5, 2013
First Posted: May 3, 2013
Results First Submitted: June 5, 2015
Results First Posted: July 1, 2015
Last Update Posted: July 23, 2015