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

Psoriatic Arthritis Clinical Trial

— AMVISION-1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02029495
• Other study ID #: 20090406
• Secondary ID: 2013-003554-25
• Status: Terminated
• Phase: Phase 3
• First received: January 6, 2014
• Last updated: June 9, 2016
• Start date: March 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health CanadaBelgium: Federal Agency for Medicinal Products and Health ProductsCzech Republic: State Institute for Drug ControlFrance: National Agency for Medicines and Health Products Safety (ANSM)Greece: National Organization of Medicines (EOF)Hungary: National Institute for PharmacyItaly: The Italian Medicines Agency (AIFA)Mexico: Federal Commission for Protection Against Health Risks (COFEPRIS)Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: The Ministry of Healthcare of the Russian Federation (Minzdrav)Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)Switzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 478
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• 210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection
• 140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection
• Placebo
Placebo administered via subcutaneous injection until week 24.

Locations

Country	Name	City	State
Belgium	Research Site	Hasselt
Belgium	Research Site	Leuven
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Quebec
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Waterloo	Ontario
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Ceske Budejovice
Czech Republic	Research Site	Ostrava-Trebovice
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Uherske Hradiste
Estonia	Research Site	Pärnu
Estonia	Research Site	Tallinn
France	Research Site	Cahors Cedex
France	Research Site	Orleans cedex 2
France	Research Site	Rennes cedex 2
France	Research Site	Saint-Etienne Cedex 2
France	Research Site	Toulouse Cedex 9
France	Research Site	Tours Cedex 1
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Heraklion
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Esztergom
Hungary	Research Site	Nyiregyhaza
Hungary	Research Site	Szekesfehervar
Hungary	Research Site	Szolnok
Italy	Research Site	Firenze
Italy	Research Site	Milano
Italy	Research Site	Pavia
Italy	Research Site	Roma
Italy	Research Site	Roma (RM)
Italy	Research Site	Rome
Italy	Research Site	Verona
Mexico	Research Site	Chihuahua
Mexico	Research Site	Ciudad Obregon	Sonora
Mexico	Research Site	Distrito Federal
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Guadalajara	Jalisco
Mexico	Research Site	Leon	Guanajuato
Mexico	Research Site	Merida	Yucatán
Mexico	Research Site	Mexicali	Baja California Norte
Poland	Research Site	Gdansk
Poland	Research Site	Gdynia
Poland	Research Site	Katowice
Poland	Research Site	Lodz
Poland	Research Site	Lodz
Poland	Research Site	Lublin
Poland	Research Site	Poznan
Poland	Research Site	Stalowa Wola
Poland	Research Site	Swidnik
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Warszawa
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Ekaterinburg
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Nizhniy Novgorod
Russian Federation	Research Site	Nizhny Novgorod
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	Saint-Petersburg
Russian Federation	Research Site	Saratov
Russian Federation	Research Site	Yaroslavl
Slovakia	Research Site	Banska Bystrica
Slovakia	Research Site	Lucenec
Slovakia	Research Site	Rimavska Sobota
Slovakia	Research Site	Zilina
Spain	Research Site	A Coruña	Galicia
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Barcelona	Cataluña
Spain	Research Site	Cordoba	Andalucía
Spain	Research Site	Granada	Andalucía
Spain	Research Site	Hospitalet de Llobregat	Cataluña
Spain	Research Site	La Vila-Joiosa	Comunidad Valenciana
Spain	Research Site	Madrid
Spain	Research Site	Madrid
Spain	Research Site	Merida	Extremadura
Spain	Research Site	Sabadell	Cataluña
Spain	Research Site	Sevilla	Andalucía
Switzerland	Research Site	Basel
Switzerland	Research Site	Geneva 14
Switzerland	Research Site	Lausanne
Switzerland	Research Site	Zurich
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Glasgow
United Kingdom	Research Site	Hull
United Kingdom	Research Site	Leeds
United Kingdom	Research Site	London
United Kingdom	Research Site	London
United Kingdom	Research Site	Manchester
United States	Research Site	Asheville	North Carolina
United States	Research Site	Austin	Texas
United States	Research Site	Beckley	West Virginia
United States	Research Site	Bend	Oregon
United States	Research Site	Bowling Green	Kentucky
United States	Research Site	Bridgeport	West Virginia
United States	Research Site	Charleston	South Carolina
United States	Research Site	Clifton	New Jersey
United States	Research Site	Danville	Virginia
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Eagan	Minnesota
United States	Research Site	Frederick	Maryland
United States	Research Site	Gainesville	Georgia
United States	Research Site	Glendale	Wisconsin
United States	Research Site	Great Neck	New York
United States	Research Site	Hixson	Tennessee
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Jupiter	Florida
United States	Research Site	Lake Success	New York
United States	Research Site	Lansing	Michigan
United States	Research Site	Los Angeles	California
United States	Research Site	Mather	California
United States	Research Site	Meridian	Idaho
United States	Research Site	Murrieta	California
United States	Research Site	New York	New York
United States	Research Site	Omaha	Nebraska
United States	Research Site	Palm Desert	California
United States	Research Site	Peoria	Arizona
United States	Research Site	Plainview	New York
United States	Research Site	Portland	Oregon
United States	Research Site	San Antonio	Texas
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Somerset	Kentucky
United States	Research Site	Springfield	Illinois
United States	Research Site	Tamarac	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Tuscaloosa	Alabama
United States	Research Site	Tustin	California
United States	Research Site	Upland	California
United States	Research Site	Wheaton	Maryland
United States	Research Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Belgium,  Bulgaria,  Canada,  Czech Republic,  Estonia,  France,  Greece,  Hungary,  Italy,  Mexico,  Poland,  Russian Federation,  Slovakia,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American College of Rheumatology (ACR) 20 response	To evaluate the efficacy of brodalumab compared to placebo, in subjects with psoriatic arthritis.	16 weeks	No
Secondary	Psoriasis Area and Severity Index (PASI) 75	To evaluate the efficacy of brodalumab compared to placebo at week 16.	16 Weeks	No
Secondary	Health Assessment Questionnaire-Disability Index (HAQ-DI)	To evaluate the efficacy of brodalumab compared to placebo at week 16.	16 Weeks	No
Secondary	Psoriasis Symptom Inventory responder definition	To evaluate the efficacy of brodalumab compared to placebo at week 16.	16 Weeks	No
Secondary	Van der Heijde modified Total Sharp score (mTSS)	To evaluate the effect of brodalumab compared to placebo at week 24	24 Weeks	No

External Links

•   AmgenTrials clinical trials website