AMG 827 in Subjects With Psoriatic Arthritis | NCT01516957

Label	Type	Description	Intervention Names
AMG 827 140	Experimental	140 mg AMG 827	Drug: AMG 827 140
Placebo SC	Placebo Comparator	Placebo	Drug: Placebo
AMG 827 280	Experimental	280 mg AMG 827	Drug: AMG 827 280
AMG 827 210	Experimental	AMG 827 SC 210 mg	Drug: AMG 827 210

Name	Type	Description	Arm Group Labels	Other Names
AMG 827 140	Drug	140 mg AMG 827 SC (subcutaneous)	AMG 827 140
Placebo

Measure	Description	Time Frame
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%	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.	Baseline to week 12

Measure	Description	Time Frame
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50	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.

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
MD	Amgen	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Peoria	Arizona	85381	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
24918373	Background	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.
26773108	Derived	Mease PJ, Genovese MC, Mutebi A, Viswanathan HN, Chau D, Feng J, Erondu N, Nirula A. Improvement in Psoriasis Signs and Symptoms Assessed by the Psoriasis Symptom Inventory with Brodalumab Treatment in Patients with Psoriatic Arthritis. J Rheumatol. 2016 Feb;43(2):343-9. doi: 10.3899/jrheum.150182. Epub 2016 Jan 15.

Label	URL
AmgenTrials clinical trials website	View source

ID	Title	Description
FG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
FG001	140mg SC	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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%

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to week 12

ID	Title	Description
OG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
OG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
OG002	AMG 827 280	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)

Units	Counts
Participants	OG00052 OG00153 OG00250

Title

Denominators

Categories

Title	Measurements
	OG00019.2(9.6 to 32.5) OG00139.6(26.5 to 54) OG00244(30 to 58.7)

Secondary

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to week 12

ID	Title	Description
OG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
OG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
OG002	AMG 827 280	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)

Secondary

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70

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.

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

Posted

Number

95% Confidence Interval

percentage of participants

Baseline to week 12

ID	Title	Description
OG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
OG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
OG002	AMG 827 280	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)

Secondary

To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)

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)

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

Posted

Mean

Standard Deviation

score on a scale

Baseline to week 12

ID	Title	Description
OG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
OG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
OG002	AMG 827 280

Secondary

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)

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline to week 12

ID	Title	Description
OG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
OG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
OG002

Serious Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Cellulitis	Infections and infestations	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0022 affected51 at risk EG0032 affected156 at risk
Influenza	Infections and infestations	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Osteomyelitis	Infections and infestations	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Pnuemona	Infections and infestations	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Psoas Abscess	Infections and infestations	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Pyelonephritis	Infections and infestations	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Septic Athritis Streptococcal	Infections and infestations	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Sphingomonas Paucimobilis infection	Infections and infestations	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Coronary Artery Disease	Cardiac disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0013 affected53 at risk EG0020 affected51 at risk EG003
Acute Myocardial Infarction	Cardiac disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Coronary Artery Stenosis	Cardiac disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Left Ventricular Dysfunction	Cardiac disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0022 affected51 at risk EG003
Back Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Intervertebral Disc Protusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Musculoskeletal Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0012 affected53 at risk EG0020 affected51 at risk EG003
Abdominal Pain	Gastrointestinal disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Abdominal Pain Upper	Gastrointestinal disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Cholecystitis	Hepatobiliary disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Cholelithiasis	Hepatobiliary disorders	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Malignant Melinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
tendon Rupture	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0022 affected51 at risk EG003
Procedural Pain	Injury, poisoning and procedural complications	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Cerebral Infarction	Nervous system disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Syncope	Nervous system disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Aortic Stenosis	Vascular disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0022 affected51 at risk EG003
Thrombosis in Device	General disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Diabetic Ketacidosis	Metabolism and nutrition disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Suicidal Ideation	Psychiatric disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Pelvi-Ureteric obstruction	Renal and urinary disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Skin Ulcer	Skin and subcutaneous tissue disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Knee Arthroplasty	Surgical and medical procedures	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Completed suicide	Psychiatric disorders	Non-systematic Assessment	EG0000 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003

Other Adverse Events

Term	Organ System	Assessment Type	Statistical Information
Upper respiratory Tract Infection	Infections and infestations	Non-systematic Assessment	EG0008 affected52 at risk EG00114 affected53 at risk EG00211 affected51 at risk EG00333 affected156 at risk
Nasopharyngitis	Investigations	Non-systematic Assessment	EG0009 affected52 at risk EG00110 affected53 at risk EG00210 affected51 at risk EG003
urinary tract infection	Infections and infestations	Non-systematic Assessment	EG0005 affected52 at risk EG00110 affected53 at risk EG0028 affected51 at risk EG003
Bronchitis	Infections and infestations	Non-systematic Assessment	EG0006 affected52 at risk EG0018 affected53 at risk EG0027 affected51 at risk EG003
Sinusitis	Infections and infestations	Non-systematic Assessment	EG0004 affected52 at risk EG0018 affected53 at risk EG0029 affected51 at risk EG003
Bursitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0015 affected53 at risk EG0022 affected51 at risk EG003
joint effusion	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected52 at risk EG0012 affected53 at risk EG0021 affected51 at risk EG003
Fibromyalgia	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0011 affected53 at risk EG0022 affected51 at risk EG003
Tendonitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected52 at risk EG0012 affected53 at risk EG0021 affected51 at risk EG003
Tendon Disorder	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected52 at risk EG0011 affected53 at risk EG0020 affected51 at risk EG003
Plantar Fascitis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0003 affected52 at risk EG0010 affected53 at risk EG0020 affected51 at risk EG003
Spinal Osteoarthrosis	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0002 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Musculoskeletal Chest Pain	Musculoskeletal and connective tissue disorders	Non-systematic Assessment	EG0001 affected52 at risk EG0010 affected53 at risk EG0021 affected51 at risk EG003
Diarrhoea	General disorders	Non-systematic Assessment	EG0003 affected52 at risk EG00112 affected53 at risk EG0029 affected51 at risk EG003
Nausea	Gastrointestinal disorders	Non-systematic Assessment	EG0004 affected52 at risk EG0016 affected53 at risk EG0025 affected51 at risk EG003

ID	Term
D015535	Arthritis, Psoriatic
D009140	Musculoskeletal Diseases
D025242	Spondylarthropathies

ID	Term
D025241	Spondylarthritis
D013166	Spondylitis
D013122	Spinal Diseases
D001847	Bone Diseases
D001168	Arthritis
D007592	Joint Diseases
D011565	Psoriasis
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Title	Description
BG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)
BG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
BG002	AMG 827 280	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
BG003	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo SC	Placebo Placebo: Placebo SC (subcutaneous)	13	52	52	52
EG001	AMG 827 140	140 mg AMG 827 AMG 827 140: 140 mg AMG 827 SC (subcutaneous)	15	53	50	53
EG002	AMG 827 280	280 mg AMG 827 AMG 827 280: 280 mg AMG 827 SC (subcutaneous)	18	51	50	51
EG003	Open Label 210 mg or 280 mg AMG 827	Open label 210 mg or 280 mg AMG 827 after Week 12	31	156	153	156