Efficacy and Safety Study of ABP 501 Compared to Adalimumab in Subjects With Moderate to Severe Rheumatoid Arthritis

• ClinicalTrials.gov Identifier: NCT01970475
• Recruitment Status: Completed
• First Posted: October 28, 2013
• Results First Posted: December 13, 2016
• Last Update Posted: December 13, 2016
• Sponsor: Amgen
• Information provided by (Responsible Party): Amgen

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Arthritis, Rheumatoid
• Interventions: Biological: ABP 501; Biological: Adalimumab
• Enrollment: 526

Participant Flow

Recruitment Details	This study was conducted at 92 centers in 12 countries in Europe, North America and Latin America. The first participant enrolled on 24 October 2013 and the last participant enrolled on 26 May 2014.
Pre-assignment Details	Participants were randomized 1:1 to receive either ABP 501 or adalimumab at 40 mg every 2 weeks for 22 weeks. Randomization was stratified by geographic region and prior biologic use for rheumatoid arthritis (capped at 40% of the study population).

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Period Title: Overall Study
Started	264	262
Completed	243	251
Not Completed	21	11
Reason Not Completed
Withdrawal by Subject	11	6
Adverse Event	7	3
Lost to Follow-up	2	2
Protocol Violation	1	0

Baseline Characteristics

Arm/Group Title		ABP 501	Adalimumab	Total
Arm/Group Description		Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Total of all reporting groups
Overall Number of Baseline Participants		264	262	526
Baseline Analysis Population Description		The full analysis set (all randomized participants)
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	264 participants	262 participants	526 participants
		55.4 (11.88)	56.3 (11.47)	55.9 (11.67)
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	264 participants	262 participants	526 participants
< 65 years		205	197	402
≥ 65 years		59	65	124
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	264 participants	262 participants	526 participants
	Female	214 81.1%	212 80.9%	426 81.0%
	Male	50 18.9%	50 19.1%	100 19.0%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	264 participants	262 participants	526 participants
White		251	249	500
Black or African American		9	12	21
Asian		3	0	3
American Indian or Alaska Native		0	0	0
Native Hawaiian or Other Pacific Islander		0	0	0
Other		1	1	2
Ethnicity; Measure Type: Number; Unit of measure: Participants	Number Analyzed	264 participants	262 participants	526 participants
Hispanic or Latino		33	25	58
Not Hispanic or Latino		230	236	466
Not Allowed to Collect		1	1	2
Geographic Region; Measure Type: Number; Unit of measure: Participants	Number Analyzed	264 participants	262 participants	526 participants
Eastern Europe		169	168	337
Western Europe		22	20	42
North America		72	72	144
Latin America		1	2	3
Prior Biological Use for Rheumatoid Arthritis (RA); Measure Type: Number; Unit of measure: Participants	Number Analyzed	264 participants	262 participants	526 participants
Yes		71	74	145
No		193	188	381
Duration of RA; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	264 participants	262 participants	526 participants
		9.41 (8.076)	9.37 (8.047)	9.39 (8.054)
Swollen Joint Count [1]; Mean (Standard Deviation); Unit of measure: Swollen joints
	Number Analyzed	264 participants	262 participants	526 participants
		14.7 (9.05)	14.1 (7.98)	14.4 (8.53)
		[1] Measure Description: Sixty-six joints were assessed and classified as swollen/not swollen by pressure and joint manipulation on physical examination.
Tender Joint Count [1]; Mean (Standard Deviation); Unit of measure: Tender joints
	Number Analyzed	264 participants	262 participants	526 participants
		24.3 (14.35)	23.9 (13.49)	24.1 (13.92)
		[1] Measure Description: Sixty-eight joints were assessed and classified as tender/not tender by pressure and joint manipulation on physical examination.
Subject Global Health Assessment [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	264 participants	262 participants	526 participants
		6.5 (1.92)	6.6 (1.86)	6.5 (1.89)
		[1] Measure Description: The participant's overall assessment of their disease activity in the past week on a 0 to 10 horizontal scale. The left-hand extreme of the scale was described as "no RA activity at all" (symptom-free and no arthritis symptoms; score = 0) and the right-hand extreme as "worst RA activity imaginable" (maximum arthritis disease activity; score = 10).
Investigator Global Health Assessment [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	264 participants	262 participants	526 participants
		6.8 (1.29)	6.7 (1.59)	6.8 (1.45)
		[1] Measure Description: The Investigator's assessment of the participant's current disease activity on a 0 to 10 horizontal scale. The left-hand extreme of the scale was described as "no activity at all" (symptom-free and no arthritis symptoms; score = 0) and the right-hand extreme as "worst activity imaginable" (maximum arthritis disease activity; score = 10).
Subject's Assessment of Disease Related Pain [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	264 participants	262 participants	526 participants
		58.3 (21.82)	60.6 (22.37)	59.5 (22.11)
		[1] Measure Description: The participant's assessment of their current level of pain on a 100 mm horizontal visual analogue scale (VAS). The left-hand extreme of the line was described as "no pain at all" (score = 0) and the right-hand extreme as "worst pain imaginable" (score = 100).
Health Assessment Questionnaire-Disability Index (HAQ-DI) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	264 participants	262 participants	526 participants
		1.4819 (0.61715)	1.4976 (0.64743)	1.4897 (0.63186)
		[1] Measure Description: The HAQ-DI questionnaire asks participants to rate their level of difficulty on daily activities as well as their use of aids, devices, or help from another person for these activities and disabilities. Responses are scored from 0 indicating no difficulty to 3 indicating inability to perform a task in that area. The overall score is the average of each of the 8 category scores and ranges from 0 (no disability) to 3 (very severe, high-dependency disability). Data are available for 263 and 261 participants in each group respectively.
C-reactive Protein; Mean (Standard Deviation); Unit of measure: mg/L
	Number Analyzed	264 participants	262 participants	526 participants
		13.881 (20.6870)	14.678 (19.3848)	14.278 (20.0338)
Disease Activity Score 28-C-Reactive Protein (DAS28-CRP) [1]; Mean (Standard Deviation); Unit of measure: Units on a scale
	Number Analyzed	264 participants	262 participants	526 participants
		5.66 (0.918)	5.68 (0.911)	5.67 (0.914)
		[1] Measure Description: The DAS28-CRP is a composite score to measure disease activity in patients with RA, derived from the following variables: The number of swollen and tender joints (28-joint count);; C-reactive protein (CRP);; Patient's global assessment of disease activity assessed on a scale from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). DAS28-CRP scores range from approximately zero to ten. Higher scores indicate higher disease activity. Data are available for 264 and 261 participants in each group respectively.

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Week 24
Description	A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in tender joint count;; ≥ 20% improvement in swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-Reactive Protein level.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

The full analysis set (all randomized participants); missing values were imputed using the last observation carried forward (LOCF) method for participants with at least 1 postbaseline value.

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	260	261
Measure Type: Number; Unit of Measure: percentage of participants
	74.6	72.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	ABP 501, Adalimumab
	Comments	The study hypothesis was that there were no clinically meaningful differences between ABP 501 and adalimumab in risk ratio (RR) of ACR20 at week 24.
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	The hypothesis was tested by comparing the 2-sided 90% confidence interval (CI) of the RR of ACR20 at week 24 between ABP 501 and adalimumab with an equivalence margin of (0.738, 1/0.738).
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.039
	Confidence Interval	(2-Sided) 90%; 0.954 to 1.133
	Estimation Comments	Based on a generalized linear model adjusted for geographic region and prior biological use for RA as covariates in the model.

2. Secondary Outcome

Title	Change From Baseline in Disease Activity Score 28-C-reactive Protein (DAS28-CRP)
Description	The DAS28-CRP is a composite score to measure disease activity in patients with rheumatoid arthritis, derived from the following variables: The number of swollen and tender joints assessed using the 28-joint count;; C-reactive protein (CRP) level; Patient's global assessment of disease activity assessed on a score from 0 to 100 transformed from the result measured on a horizontal scale from 0 (no RA activity at all) to 10 (worst RA activity imaginable). The DAS28-CRP score ranges from approximately zero to ten. Higher DAS28-CRP scores indicate higher disease activity. A repeated measures analysis with the DAS28-CRP change from baseline as the response and the stratification variables, visit, treatment, treatment-by-visit interaction and the baseline DAS28-CRP measurement as predictors in the model was performed.
Time Frame	Baseline and weeks 2, 4, 8, 12, 18, and 24

Outcome Measure Data

Analysis Population Description

Full analysis set with available data at each time point

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	264	262
Least Squares Mean (Standard Deviation); Unit of Measure: units on a scale
Week 2 (n = 254, 252)	-1.01 (0.891)	-0.96 (0.890)
Week 4 (n = 255, 254)	-1.45 (1.048)	-1.42 (0.979)
Week 8 (n = 247, 255)	-1.79 (1.075)	-1.70 (1.093)
Week 12 (n = 245, 250)	-2.04 (1.112)	-1.93 (1.171)
Week 18 (n = 244, 250)	-2.30 (1.184)	-2.17 (1.189)
Week 24 (n = 243, 250)	-2.32 (1.237)	-2.32 (1.209)

3. Secondary Outcome

Title	Percentage of Participants With an ACR20 Response at Week 2 and Week 8
Description	A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 20% improvement in tender joint count;; ≥ 20% improvement in swollen joint count; and; ≥ 20% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-Reactive Protein level.
Time Frame	Baseline, week 2 and week 8

Outcome Measure Data

Analysis Population Description

Full analysis set; LOCF imputation was used for participants with at least 1 postbaseline value (indicated by n).

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	264	262
Measure Type: Number; Unit of Measure: percentage of participants
Week 2 (n = 254, 257)	35.4	24.5
Week 8 (n = 260, 261)	63.5	62.5

4. Secondary Outcome

Title	Percentage of Participants With an ACR50 Response at Week 24
Description	A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 50% improvement in tender joint count;; ≥ 50% improvement in swollen joint count; and; ≥ 50% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-Reactive Protein level.
Time Frame	Baseline and week 24

Outcome Measure Data

Analysis Population Description

Full analysis set with available data at week 24

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	244	252
Measure Type: Number; Unit of Measure: percentage of participants
	49.2	52.0

5. Secondary Outcome

Title	Percentage of Participants With an ACR70 Response at Week 24
Description	A participant was a responder if the following 3 criteria for improvement from Baseline were met: ≥ 70% improvement in tender joint count;; ≥ 70% improvement in swollen joint count; and; ≥ 70% improvement in at least 3 of the 5 following parameters: Patient's assessment of pain (measured on a 100 mm visual analog scale [VAS]); Patient's global assessment of disease activity (measured on a likert scale from 0 to 10); Physician's global assessment of disease activity (measured on a likert scale from 0 to 10); Patient's self-assessment of physical function (Health Assessment Questionnaire - Disability Index [HAQ-DI]); C-Reactive Protein level.
Time Frame	Baseline and Week 24

Outcome Measure Data

Analysis Population Description

Full analysis set with available data at week 24

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	246	253
Measure Type: Number; Unit of Measure: percentage of participants
	26.0	22.9

6. Secondary Outcome

Title	Number of Participants With Adverse Events
Description	Adverse events (AEs) were graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 according to the following scale: 1 = mild; 2 = moderate; 3 = severe; 4 = life-threatening; 5 = fatal. A treatment-related AE is defined as an event where the answer to the question "is there a reasonable possibility that the event may have been caused by the Investigational Medicinal Product" was yes. A serious adverse event is defined as an AE that meets at least 1 of the following serious criteria: fatal; life threatening (places the subject at immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; congenital anomaly/birth defect; other medically important serious event.
Time Frame	From the time of first treatment up to 28 days following the last dose of study treatment; 26 weeks.

Outcome Measure Data

Analysis Population Description

The safety analysis set (all participants who received at least 1 dose of study drug)

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	264	262
Measure Type: Number; Unit of Measure: participants
Any adverse event (AE)	132	143
Adverse event ≥ grade 3	9	17
Treatment-related adverse event (TRAE)	50	55
Treatment-related adverse event ≥ grade 3	3	2
Serious adverse event (SAE)	10	13
Treatment-related serious adverse event	4	1
AE leading to discontinuation of study drug	5	2
TRAE leading to discontinuation of study drug	4	1
AE leading to discontinuation from study	7	2
TRAE leading to discontinuation from study	5	0

7. Secondary Outcome

Title	Percentage of Participants Who Developed Antibodies to ABP 501 or Adalimumab
Description	Two validated assays were used to detect the presence of anti-drug antibodies. Samples were first tested in an electrochemiluminescence (ECL)-based bridging immunoassay to detect anti-drug antibodies (ADA) against ABP 501 and adalimumab (Binding Antibody Assay). Samples confirmed to be positive for binding antibodies were subsequently tested in a non-cell based bioassay to determine neutralizing activity against ABP 501 or adalimumab (Neutralizing Antibody Assay). Developing antibody incidence is defined as a negative or no antibody result at baseline and a positive antibody result at a post-baseline time point.
Time Frame	Up to week 26

Outcome Measure Data

Analysis Population Description

Participants with at least 1 evaluable antibody test result (to either ABP 501 or adalimumab)

Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description:	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
Overall Number of Participants Analyzed	264	262
Measure Type: Number; Unit of Measure: percentage of participants
Developing Binding Antibody	38.3	38.2
Developing Neutralizing Antibody	9.1	11.1

Adverse Events

Time Frame	From the time of first treatment but on or within 28 days following the last dose of study treatment; 26 weeks.
Adverse Event Reporting Description	Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
Arm/Group Title	ABP 501	Adalimumab
Arm/Group Description	Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.	Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
All-Cause Mortality
	ABP 501	Adalimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	ABP 501	Adalimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/264 (3.79%)	13/262 (4.96%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	1/264 (0.38%)	0/262 (0.00%)
Cardiac disorders
Acute myocardial infarction † 1	0/264 (0.00%)	1/262 (0.38%)
Cardiac failure congestive † 1	0/264 (0.00%)	1/262 (0.38%)
Cardiopulmonary failure † 1	1/264 (0.38%)	0/262 (0.00%)
Myocardial infarction † 1	0/264 (0.00%)	1/262 (0.38%)
Wolff-Parkinson-White syndrome † 1	0/264 (0.00%)	1/262 (0.38%)
Gastrointestinal disorders
Enterocolitis † 1	1/264 (0.38%)	0/262 (0.00%)
Large intestinal obstruction † 1	0/264 (0.00%)	1/262 (0.38%)
Immune system disorders
Corneal graft rejection † 1	0/264 (0.00%)	1/262 (0.38%)
Hypersensitivity † 1	1/264 (0.38%)	0/262 (0.00%)
Infections and infestations
Appendicitis perforated † 1	1/264 (0.38%)	0/262 (0.00%)
Arthritis bacterial † 1	0/264 (0.00%)	1/262 (0.38%)
Gastroenteritis † 1	0/264 (0.00%)	1/262 (0.38%)
Peritoneal abscess † 1	1/264 (0.38%)	0/262 (0.00%)
Pneumonia † 1	1/264 (0.38%)	0/262 (0.00%)
Pneumonia fungal † 1	0/264 (0.00%)	1/262 (0.38%)
Sepsis † 1	2/264 (0.76%)	0/262 (0.00%)
Injury, poisoning and procedural complications
Humerus fracture † 1	1/264 (0.38%)	0/262 (0.00%)
Meniscus injury † 1	1/264 (0.38%)	0/262 (0.00%)
Thoracic vertebral fracture † 1	0/264 (0.00%)	1/262 (0.38%)
Musculoskeletal and connective tissue disorders
Foot deformity † 1	0/264 (0.00%)	1/262 (0.38%)
Osteoarthritis † 1	0/264 (0.00%)	1/262 (0.38%)
Pseudarthrosis † 1	0/264 (0.00%)	1/262 (0.38%)
Nervous system disorders
Cerebrovascular accident † 1	1/264 (0.38%)	0/262 (0.00%)
Vascular disorders
Hypertension † 1	1/264 (0.38%)	0/262 (0.00%)
Venous thrombosis limb † 1	1/264 (0.38%)	0/262 (0.00%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ABP 501	Adalimumab
	Affected / at Risk (%)	Affected / at Risk (%)
Total	17/264 (6.44%)	19/262 (7.25%)
Infections and infestations
Nasopharyngitis † 1	17/264 (6.44%)	19/262 (7.25%)
† Indicates events were collected by systematic assessment; 1 Term from vocabulary, MedDRA 17.1

Limitations and Caveats

[Not Specified]

More Information

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.

The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.

Results Point of Contact

• Name/Title: Study Director
• Organization: Amgen Inc.
• Phone: 866-572-6436

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Huizinga TWJ, Torii Y, Muniz R. Adalimumab Biosimilars in the Treatment of Rheumatoid Arthritis: A Systematic Review of the Evidence for Biosimilarity. Rheumatol Ther. 2021 Mar;8(1):41-61. doi: 10.1007/s40744-020-00259-8. Epub 2020 Dec 1.

Cohen S, Genovese MC, Choy E, Perez-Ruiz F, Matsumoto A, Pavelka K, Pablos JL, Rizzo W, Hrycaj P, Zhang N, Shergy W, Kaur P. Efficacy and safety of the biosimilar ABP 501 compared with adalimumab in patients with moderate to severe rheumatoid arthritis: a randomised, double-blind, phase III equivalence study. Ann Rheum Dis. 2017 Oct;76(10):1679-1687. doi: 10.1136/annrheumdis-2016-210459. Epub 2017 Jun 5.

• Responsible Party: Amgen
• ClinicalTrials.gov Identifier: NCT01970475
• Other Study ID Numbers: 20120262; 2013-000525-31 ( EudraCT Number )
• First Submitted: October 23, 2013
• First Posted: October 28, 2013
• Results First Submitted: October 20, 2016
• Results First Posted: December 13, 2016
• Last Update Posted: December 13, 2016