AMG 827 in Subjects With Psoriatic Arthritis

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01516957
• Collaborator: (none)
• Enrollment: 168
• Locations: 31
• Arms: 4
• Duration (Months): 47
• Patients Per Site: 5.4
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Condition or Disease	Intervention/Treatment	Phase
Psoriatic Arthritis	Drug: AMG 827 140; Drug: Placebo; Drug: AMG 827 280; Drug: AMG 827 210	Phase 2

Detailed Description

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Study Design

• Study Type: Interventional
• Actual Enrollment: 168 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis.
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Sep 1, 2012
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AMG 827 140 140 mg AMG 827	Drug: AMG 827 140; 140 mg AMG 827 SC (subcutaneous)
Placebo Comparator: Placebo SC Placebo	Drug: Placebo; Placebo SC (subcutaneous)
Experimental: AMG 827 280 280 mg AMG 827	Drug: AMG 827 280; 280 mg AMG 827 SC (subcutaneous)
Experimental: AMG 827 210 AMG 827 SC 210 mg	Drug: AMG 827 210; 210 mg AMG 827 SC (subcutaneous)

Outcome Measures

Primary Outcome Measures

1. To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20% [Baseline to week 12]

   To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.

Secondary Outcome Measures

1. To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 [Baseline to week 12]

   To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12. ACR50 responders are subjects with 50% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.

2. To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 [Baseline to week 12]

   To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12. ACR70 responders are subjects with 70% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.

3. To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI) [Baseline to week 12]

   To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12. CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) A CDAI reduction of 6.5 represents moderate improvement. EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)

4. To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28) [Baseline to week 12]

   To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12. The DAS28 is a composite score derived from 4 measures. To calculate the DAS28: count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask the participant to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months

• Subject has ≥ 3 tender and ≥ 3 swollen joints

Exclusion Criteria:

• Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic)

• Significant concurrent medical conditions

• Pregnant or breast feeding

• Significant Laboratory abnormalities

• Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days

• Use of anti-TNF therapy within 2 months

• Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months

• Prior use of rituximab

• Prior use of anti-IL-17 biologic therapy, including AMG 827

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Peoria	Arizona	United States	85381
2	Research Site	Scottsdale	Arizona	United States	85258
3	Research Site	Tucson	Arizona	United States	85711
4	Research Site	Hemet	California	United States	92543
5	Research Site	Huntington Beach	California	United States	92646
6	Research Site	La Jolla	California	United States	92037
7	Research Site	Los Angeles	California	United States	90095
8	Research Site	Palm Desert	California	United States	92260
9	Research Site	Palo Alto	California	United States	94304
10	Research Site	Victorville	California	United States	92395
11	Research Site	Sarasota	Florida	United States	34239
12	Research Site	Boise	Idaho	United States	83702
13	Research Site	Lexington	Kentucky	United States	40504
14	Research Site	Baton Rouge	Louisiana	United States	70809
15	Research Site	Frederick	Maryland	United States	21702
16	Research Site	Grand Rapids	Michigan	United States	49546
17	Research Site	Lansing	Michigan	United States	48910
18	Research Site	Lebanon	New Hampshire	United States	03756
19	Research Site	Rochester	New York	United States	14642
20	Research Site	Portland	Oregon	United States	97239
21	Research Site	Duncansville	Pennsylvania	United States	16635
22	Research Site	Seattle	Washington	United States	98122
23	Research Site	Victoria	British Columbia	Canada	V8P 5P6
24	Research Site	Winnipeg	Manitoba	Canada	R3A 1M3
25	Research Site	St. John's	Newfoundland and Labrador	Canada	A1A 5E8
26	Research Site	St. John's	Newfoundland and Labrador	Canada	A1C 5B8
27	Research Site	Newmarket	Ontario	Canada	L3Y 3R7
28	Research Site	Ottawa	Ontario	Canada	K1H 8L6
29	Research Site	Trois-Rivieres	Quebec	Canada	G8Z 1Y2
30	Research Site	QC		Canada	G1W 4R4
31	Research Site	Quebec		Canada	G1V 3M7

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Study Director: MD, Amgen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• AmgenTrials clinical trials website

Publications

• Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01516957
• Other Study ID Numbers: 20101227
• First Posted: Jan 25, 2012
• Last Update Posted: Aug 27, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Bausch Health Americas, Inc.: Psoriatic Arthritis; IL-17; AMG 827; AMG827; Musculoskeletal Disease; Spondylarthropathy
• Additional relevant MeSH terms: Arthritis; Arthritis, Psoriatic; Brodalumab; Antibodies, Monoclonal

Study Results

Participant Flow

Recruitment Details	A total of 168 subjects were enrolled in the double-blind phase of the study. Of these 168 subjects, 156 entered the open-label extension phase (52 subjects were previously dosed with placebo, 53 subjects with brodalumab 140 mg Q2W, and 51 subjects with brodalumab 280 mg Q2W).

Arm/Group Title	Placebo SC	140mg SC	280mg SC	Open Label AMG 827 SC 210 or 280 mg
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)	Open label 210 mg or 280 mg AMG 827 SC (subcutaneous), after Week 12.
Period Title: Placebo-controlled Phase
STARTED	55	57	56	0
COMPLETED	52	53	51	0
NOT COMPLETED	3	4	5	0
Period Title: Placebo-controlled Phase
STARTED	0	0	0	156
COMPLETED	0	0	0	0
NOT COMPLETED	0	0	0	156

Baseline Characteristics

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280	Total
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)	Total of all reporting groups
Overall Participants	52	53	51	156
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	43 82.7%	48 90.6%	44 86.3%	135 86.5%
>=65 years	9 17.3%	5 9.4%	7 13.7%	21 13.5%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.4 (13.2)	52.8 (9.3)	50.5 (11.8)	52.3 (11.5)
Sex: Female, Male (Count of Participants)
Female	28 53.8%	33 62.3%	36 70.6%	97 62.2%
Male	24 46.2%	20 37.7%	15 29.4%	59 37.8%

Outcome Measures

1. Primary Outcome

Title	To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20%
Description	To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
Measure Participants	52	53	50
Number (95% Confidence Interval) [percentage of participants]	19.2 36.9%	39.6 74.7%	44 86.3%

2. Secondary Outcome

Title	To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50
Description	To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12. ACR50 responders are subjects with 50% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
Measure Participants	52	53	51
Number (95% Confidence Interval) [percentage of participants]	3.8 7.3%	15.1 28.5%	15.7 30.8%

3. Secondary Outcome

Title	To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70
Description	To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12. ACR70 responders are subjects with 70% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
Measure Participants	52	53	51
Number (95% Confidence Interval) [percentage of participants]	0 0%	5.7 10.8%	5.9 11.6%

4. Secondary Outcome

Title	To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)
Description	To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12. CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) A CDAI reduction of 6.5 represents moderate improvement. EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity)
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
Measure Participants	50	53	51
Mean (Standard Deviation) [score on a scale]	-3.96 (10.32)	-11.32 (12.21)	-11.25 (9.16)

5. Secondary Outcome

Title	To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28)
Description	To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12. The DAS28 is a composite score derived from 4 measures. To calculate the DAS28: count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask the participant to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
Time Frame	Baseline to week 12

Outcome Measure Data

Analysis Population Description

Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit

Arm/Group Title	Placebo SC	AMG 827 140	AMG 827 280
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
Measure Participants	51	51	51
Mean (Standard Deviation) [score on a scale]	-0.42 (1.25)	-1.17 (1.39)	-1.06 (0.97)

Adverse Events

Arm/Group Title	Placebo SC		AMG 827 140		AMG 827 280		Open Label 210 mg or 280 mg AMG 827
Arm/Group Description	Placebo Placebo: Placebo SC (subcutaneous)		140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)		280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)		Open label 210 mg or 280 mg AMG 827 after Week 12
All Cause Mortality
	Placebo SC		AMG 827 140		AMG 827 280		Open Label 210 mg or 280 mg AMG 827
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo SC		AMG 827 140		AMG 827 280		Open Label 210 mg or 280 mg AMG 827
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	13/52 (25%)		15/53 (28.3%)		18/51 (35.3%)		31/156 (19.9%)
Cardiac disorders
Coronary Artery Disease	0/52 (0%)		3/53 (5.7%)		0/51 (0%)		2/156 (1.3%)
Acute Myocardial Infarction	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Coronary Artery Stenosis	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Left Ventricular Dysfunction	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Gastrointestinal disorders
Lower gastrointestinal haemorrhage	0/52 (0%)		2/53 (3.8%)		0/51 (0%)		1/156 (0.6%)
Abdominal Pain	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		0/156 (0%)
Abdominal Pain Upper	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
General disorders
Thrombosis in Device	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Hepatobiliary disorders
Cholecystitis	1/52 (1.9%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Cholelithiasis	2/52 (3.8%)		0/53 (0%)		0/51 (0%)		2/156 (1.3%)
Infections and infestations
Cellulitis	0/52 (0%)		1/53 (1.9%)		2/51 (3.9%)		2/156 (1.3%)
Influenza	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Osteomyelitis	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Pnuemona	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Psoas Abscess	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Pyelonephritis	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Septic Athritis Streptococcal	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Sphingomonas Paucimobilis infection	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Injury, poisoning and procedural complications
tendon Rupture	0/52 (0%)		0/53 (0%)		2/51 (3.9%)		1/156 (0.6%)
Procedural Pain	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Metabolism and nutrition disorders
Diabetic Ketacidosis	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Musculoskeletal and connective tissue disorders
Osteoarthritis	0/52 (0%)		0/53 (0%)		2/51 (3.9%)		1/156 (0.6%)
Back Pain	1/52 (1.9%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Intervertebral Disc Protusion	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Musculoskeletal Pain	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer	1/52 (1.9%)		1/53 (1.9%)		0/51 (0%)		0/156 (0%)
Lung Cancer Metastatic	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Malignant Melinoma	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Invasive ductal breast carcinoma	0/52 (0%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Nervous system disorders
Cerebral Infarction	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Syncope	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Psychiatric disorders
Suicidal Ideation	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Completed suicide	0/52 (0%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Renal and urinary disorders
Pelvi-Ureteric obstruction	1/52 (1.9%)		0/53 (0%)		0/51 (0%)		1/156 (0.6%)
Skin and subcutaneous tissue disorders
Skin Ulcer	0/52 (0%)		1/53 (1.9%)		0/51 (0%)		1/156 (0.6%)
Surgical and medical procedures
Knee Arthroplasty	0/52 (0%)		0/53 (0%)		1/51 (2%)		1/156 (0.6%)
Vascular disorders
Aortic Stenosis	0/52 (0%)		0/53 (0%)		2/51 (3.9%)		1/156 (0.6%)
Other (Not Including Serious) Adverse Events
	Placebo SC		AMG 827 140		AMG 827 280		Open Label 210 mg or 280 mg AMG 827
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/52 (100%)		50/53 (94.3%)		50/51 (98%)		153/156 (98.1%)
Gastrointestinal disorders
Nausea	4/52 (7.7%)		6/53 (11.3%)		5/51 (9.8%)		15/156 (9.6%)
General disorders
Diarrhoea	3/52 (5.8%)		12/53 (22.6%)		9/51 (17.6%)		24/156 (15.4%)
Infections and infestations
Upper respiratory Tract Infection	8/52 (15.4%)		14/53 (26.4%)		11/51 (21.6%)		33/156 (21.2%)
urinary tract infection	5/52 (9.6%)		10/53 (18.9%)		8/51 (15.7%)		23/156 (14.7%)
Bronchitis	6/52 (11.5%)		8/53 (15.1%)		7/51 (13.7%)		21/156 (13.5%)
Sinusitis	4/52 (7.7%)		8/53 (15.1%)		9/51 (17.6%)		21/156 (13.5%)
Investigations
Nasopharyngitis	9/52 (17.3%)		10/53 (18.9%)		10/51 (19.6%)		29/156 (18.6%)
Musculoskeletal and connective tissue disorders
Bursitis	1/52 (1.9%)		5/53 (9.4%)		2/51 (3.9%)		8/156 (5.1%)
joint effusion	2/52 (3.8%)		2/53 (3.8%)		1/51 (2%)		5/156 (3.2%)
Fibromyalgia	1/52 (1.9%)		1/53 (1.9%)		2/51 (3.9%)		4/156 (2.6%)
Tendonitis	2/52 (3.8%)		2/53 (3.8%)		1/51 (2%)		5/156 (3.2%)
Tendon Disorder	2/52 (3.8%)		1/53 (1.9%)		0/51 (0%)		3/156 (1.9%)
Plantar Fascitis	3/52 (5.8%)		0/53 (0%)		0/51 (0%)		3/156 (1.9%)
Spinal Osteoarthrosis	2/52 (3.8%)		0/53 (0%)		1/51 (2%)		3/156 (1.9%)
Musculoskeletal Chest Pain	1/52 (1.9%)		0/53 (0%)		1/51 (2%)		2/156 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.