Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic Arthritis



Status:Terminated
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:March 2014
End Date:October 2015

Use our guide to learn which trials are right for you!

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety and Effect on Radiographic Progression of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-1

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to
placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate
the efficacy of brodalumab compared to placebo at week 16 and week 24. The safety objective
of this study is to evaluate the safety profile of brodalumab in subjects with psoriatic
arthritis.


Inclusion Criteria:

- Subject has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding the
distal interphalangeal joints)).

- Subjects must have at least 1 psoriatic skin lesion as well as either ≥ 1 erosion on
a centrally read radiograph or an elevated CRP.

Exclusion Criteria:

- Subject has known history of active tuberculosis.

- Subject has a planned surgical intervention between baseline and the week 52
evaluation.

- Subject has an active infection or history of infections.

- Subject has any systemic disease (eg, renal failure, heart failure, hypertension,
liver disease, diabetes, anemia) considered by the Investigator to be clinically
significant and uncontrolled.

- Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality
that, in the opinion of the investigator, could cause this study to be detrimental to
the subject.

- Subject has severe depression measured by Personal Health Questionnaire Depression
Scale (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide
Severity Rating Scale (e-CSSRS)

- Subject has a history or evidence of psychiatric disorder or substance abuse
considered by the Investigator to pose a risk to subject safety
We found this trial at
44
sites
1894
mi
from 91732
Lansing, MI
Click here to add this to my saved trials
2002
mi
from 91732
Asheville, NC
Click here to add this to my saved trials
1213
mi
from 91732
Austin, TX
Click here to add this to my saved trials
2062
mi
from 91732
Beckley, WV
Click here to add this to my saved trials
712
mi
from 91732
Bend, OR
Click here to add this to my saved trials
1777
mi
from 91732
Bowling Green, KY
Click here to add this to my saved trials
Bridgeport, West Virginia 26330
2107
mi
from 91732
Bridgeport, WV
Click here to add this to my saved trials
Charleston, South Carolina 29412
2184
mi
from 91732
Charleston, SC
Click here to add this to my saved trials
2424
mi
from 91732
Clifton, NJ
Click here to add this to my saved trials
2166
mi
from 91732
Danville, VA
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
2200
mi
from 91732
Duncansville, PA
Click here to add this to my saved trials
1508
mi
from 91732
Eagan, MN
Click here to add this to my saved trials
2258
mi
from 91732
Frederick, MD
Click here to add this to my saved trials
1943
mi
from 91732
Gainesville, GA
Click here to add this to my saved trials
1729
mi
from 91732
Glendale, WI
Click here to add this to my saved trials
2447
mi
from 91732
Great Neck, NY
Click here to add this to my saved trials
5630
mi
from 91732
Hasselt,
Click here to add this to my saved trials
1859
mi
from 91732
Hixson, TN
Click here to add this to my saved trials
1357
mi
from 91732
Houston, TX
Click here to add this to my saved trials
1785
mi
from 91732
Huntsville, AL
Click here to add this to my saved trials
2295
mi
from 91732
Jupiter, FL
Click here to add this to my saved trials
2448
mi
from 91732
Lake Success, NY
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
358
mi
from 91732
Mather, CA
Click here to add this to my saved trials
664
mi
from 91732
Meridian, ID
Click here to add this to my saved trials
58
mi
from 91732
Murrieta, CA
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
1300
mi
from 91732
Omaha, NE
Click here to add this to my saved trials
97
mi
from 91732
Palm Desert, CA
Click here to add this to my saved trials
333
mi
from 91732
Peoria, AZ
Click here to add this to my saved trials
2461
mi
from 91732
Plainview, NY
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
352
mi
from 91732
Scottsdale, AZ
Click here to add this to my saved trials
964
mi
from 91732
Seattle, WA
Click here to add this to my saved trials
1879
mi
from 91732
Somerset, KY
Click here to add this to my saved trials
1606
mi
from 91732
Springfield, IL
Click here to add this to my saved trials
2306
mi
from 91732
Tamarac, FL
Click here to add this to my saved trials
2136
mi
from 91732
Tampa, FL
Click here to add this to my saved trials
1748
mi
from 91732
Tuscaloosa, AL
Click here to add this to my saved trials
25
mi
from 91732
Tustin, CA
Click here to add this to my saved trials
20
mi
from 91732
Upland, CA
Click here to add this to my saved trials
2279
mi
from 91732
Wheaton, MD
Click here to add this to my saved trials
2540
mi
from 91732
Worcester, MA
Click here to add this to my saved trials