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Terminated/Withdrawn
Sponsor ID
20090406

Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic ArthritisAMVISION-1

Sponsor ID
20090406
Clinicaltrials.gov ID
NCT02029495
EUCTIS ID
N/A
EudraCT ID
2013-003554-25
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Study Details

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.

Additional Study Details

Phase
Phase 3
Product
AMG 827
Type
Interventional
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment
478
Additional Study Details

Protocol Summary

Primary Outcome Measures

American College of Rheumatology (ACR) 20 response

Timeframe: 16 weeks

Secondary Outcome Measures

Psoriasis Area and Severity Index (PASI) 75

Timeframe: 16 Weeks

Health Assessment Questionnaire-Disability Index (HAQ-DI)

Timeframe: 16 Weeks

Psoriasis Symptom Inventory responder definition

Timeframe: 16 Weeks

Van der Heijde modified Total Sharp score (mTSS)

Timeframe: 24 Weeks

Locations

Location
Status
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Location
Research Site
Bridgeport, WV, United States, 26330
Status
Recruiting
Location
Research Site
Scottsdale, AZ, United States, 85258
Status
Recruiting
Location
Research Site
Cahors Cedex, France, 46005
Status
Recruiting
Location
Research Site
Charleston, SC, United States, 29406
Status
Recruiting
Location
Research Site
Duncansville, PA, United States, 16635
Status
Recruiting
Location
Research Site
Gainesville, GA, United States, 30501
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Mar 2014 - Oct 2015
    Inclusion and Exclusion Criteria
    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