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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


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
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