Trial Outcomes & Findings for AMG 827 in Subjects With Psoriatic Arthritis (NCT NCT01516957)
NCT ID: NCT01516957
Last Updated: 2020-08-27
Results Overview
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.
TERMINATED
PHASE2
168 participants
Baseline to week 12
2020-08-27
Participant Flow
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).
Participant milestones
| Measure |
Placebo SC
Placebo
Placebo: Placebo SC (subcutaneous)
|
140mg SC
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
280mg SC
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
Open Label AMG 827 SC 210 or 280 mg
Open label 210 mg or 280 mg AMG 827 SC (subcutaneous), after Week 12.
|
|---|---|---|---|---|
|
Placebo-controlled Phase
STARTED
|
55
|
57
|
56
|
0
|
|
Placebo-controlled Phase
COMPLETED
|
52
|
53
|
51
|
0
|
|
Placebo-controlled Phase
NOT COMPLETED
|
3
|
4
|
5
|
0
|
|
Open-label Phase
STARTED
|
0
|
0
|
0
|
156
|
|
Open-label Phase
COMPLETED
|
0
|
0
|
0
|
0
|
|
Open-label Phase
NOT COMPLETED
|
0
|
0
|
0
|
156
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AMG 827 in Subjects With Psoriatic Arthritis
Baseline characteristics by cohort
| Measure |
Placebo SC
n=52 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Age, Continuous
|
53.4 years
STANDARD_DEVIATION 13.2 • n=5 Participants
|
52.8 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
52.3 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
97 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
59 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit
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.
Outcome measures
| Measure |
Placebo SC
n=52 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=50 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
|---|---|---|---|
|
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%
|
19.2 percentage of participants
Interval 9.6 to 32.5
|
39.6 percentage of participants
Interval 26.5 to 54.0
|
44 percentage of participants
Interval 30.0 to 58.7
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit
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.
Outcome measures
| Measure |
Placebo SC
n=52 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
|---|---|---|---|
|
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50
|
3.8 percentage of participants
Interval 0.5 to 13.2
|
15.1 percentage of participants
Interval 6.7 to 27.6
|
15.7 percentage of participants
Interval 7.0 to 28.6
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit
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.
Outcome measures
| Measure |
Placebo SC
n=52 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
|---|---|---|---|
|
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70
|
0 percentage of participants
Interval 0.0 to 6.7
|
5.7 percentage of participants
Interval 1.2 to 15.7
|
5.9 percentage of participants
Interval 1.2 to 16.2
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit
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)
Outcome measures
| Measure |
Placebo SC
n=50 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
|---|---|---|---|
|
To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI)
|
-3.96 score on a scale
Standard Deviation 10.32
|
-11.32 score on a scale
Standard Deviation 12.21
|
-11.25 score on a scale
Standard Deviation 9.16
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Subjects who were randomized and had non-missing value for corresponding endpoint at the specified visit
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: 1. count the number of swollen joints (out of the 28), 2. count the number of tender joints (out of the 28), 3. take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), 4. 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.
Outcome measures
| Measure |
Placebo SC
n=51 Participants
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=51 Participants
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 Participants
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
|---|---|---|---|
|
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)
|
-0.42 score on a scale
Standard Deviation 1.25
|
-1.17 score on a scale
Standard Deviation 1.39
|
-1.06 score on a scale
Standard Deviation 0.97
|
Adverse Events
Placebo SC
AMG 827 140
AMG 827 280
Open Label 210 mg or 280 mg AMG 827
Serious adverse events
| Measure |
Placebo SC
n=52 participants at risk
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 participants at risk
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 participants at risk
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
Open Label 210 mg or 280 mg AMG 827
n=156 participants at risk
Open label 210 mg or 280 mg AMG 827 after Week 12
|
|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/52
|
1.9%
1/53
|
3.9%
2/51
|
1.3%
2/156
|
|
Infections and infestations
Influenza
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Infections and infestations
Osteomyelitis
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Infections and infestations
Pnuemona
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Infections and infestations
Psoas Abscess
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Infections and infestations
Septic Athritis Streptococcal
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Infections and infestations
Sphingomonas Paucimobilis infection
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/52
|
5.7%
3/53
|
0.00%
0/51
|
1.3%
2/156
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Cardiac disorders
Coronary Artery Stenosis
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/52
|
0.00%
0/53
|
3.9%
2/51
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.9%
1/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protusion
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/52
|
3.8%
2/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.00%
0/156
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Hepatobiliary disorders
Cholecystitis
|
1.9%
1/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Hepatobiliary disorders
Cholelithiasis
|
3.8%
2/52
|
0.00%
0/53
|
0.00%
0/51
|
1.3%
2/156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
1.9%
1/52
|
1.9%
1/53
|
0.00%
0/51
|
0.00%
0/156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Cancer Metastatic
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melinoma
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
tendon Rupture
|
0.00%
0/52
|
0.00%
0/53
|
3.9%
2/51
|
0.64%
1/156
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Nervous system disorders
Syncope
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Vascular disorders
Aortic Stenosis
|
0.00%
0/52
|
0.00%
0/53
|
3.9%
2/51
|
0.64%
1/156
|
|
General disorders
Thrombosis in Device
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Metabolism and nutrition disorders
Diabetic Ketacidosis
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Psychiatric disorders
Suicidal Ideation
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Renal and urinary disorders
Pelvi-Ureteric obstruction
|
1.9%
1/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/52
|
1.9%
1/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Surgical and medical procedures
Knee Arthroplasty
|
0.00%
0/52
|
0.00%
0/53
|
2.0%
1/51
|
0.64%
1/156
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/52
|
0.00%
0/53
|
0.00%
0/51
|
0.64%
1/156
|
Other adverse events
| Measure |
Placebo SC
n=52 participants at risk
Placebo
Placebo: Placebo SC (subcutaneous)
|
AMG 827 140
n=53 participants at risk
140 mg AMG 827
AMG 827 140: 140 mg AMG 827 SC (subcutaneous)
|
AMG 827 280
n=51 participants at risk
280 mg AMG 827
AMG 827 280: 280 mg AMG 827 SC (subcutaneous)
|
Open Label 210 mg or 280 mg AMG 827
n=156 participants at risk
Open label 210 mg or 280 mg AMG 827 after Week 12
|
|---|---|---|---|---|
|
Infections and infestations
Upper respiratory Tract Infection
|
15.4%
8/52
|
26.4%
14/53
|
21.6%
11/51
|
21.2%
33/156
|
|
Investigations
Nasopharyngitis
|
17.3%
9/52
|
18.9%
10/53
|
19.6%
10/51
|
18.6%
29/156
|
|
Infections and infestations
urinary tract infection
|
9.6%
5/52
|
18.9%
10/53
|
15.7%
8/51
|
14.7%
23/156
|
|
Infections and infestations
Bronchitis
|
11.5%
6/52
|
15.1%
8/53
|
13.7%
7/51
|
13.5%
21/156
|
|
Infections and infestations
Sinusitis
|
7.7%
4/52
|
15.1%
8/53
|
17.6%
9/51
|
13.5%
21/156
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
1.9%
1/52
|
9.4%
5/53
|
3.9%
2/51
|
5.1%
8/156
|
|
Musculoskeletal and connective tissue disorders
joint effusion
|
3.8%
2/52
|
3.8%
2/53
|
2.0%
1/51
|
3.2%
5/156
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.9%
1/52
|
1.9%
1/53
|
3.9%
2/51
|
2.6%
4/156
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
3.8%
2/52
|
3.8%
2/53
|
2.0%
1/51
|
3.2%
5/156
|
|
Musculoskeletal and connective tissue disorders
Tendon Disorder
|
3.8%
2/52
|
1.9%
1/53
|
0.00%
0/51
|
1.9%
3/156
|
|
Musculoskeletal and connective tissue disorders
Plantar Fascitis
|
5.8%
3/52
|
0.00%
0/53
|
0.00%
0/51
|
1.9%
3/156
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthrosis
|
3.8%
2/52
|
0.00%
0/53
|
2.0%
1/51
|
1.9%
3/156
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.9%
1/52
|
0.00%
0/53
|
2.0%
1/51
|
1.3%
2/156
|
|
General disorders
Diarrhoea
|
5.8%
3/52
|
22.6%
12/53
|
17.6%
9/51
|
15.4%
24/156
|
|
Gastrointestinal disorders
Nausea
|
7.7%
4/52
|
11.3%
6/53
|
9.8%
5/51
|
9.6%
15/156
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER