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

NCT02029495 | Terminated Phase 3 Results DMC

• 2 other identifiers: 200904062013-003554-25
• Study Type: interventional
• Target: 478
• Locations: 16 countries
• Sites: 140

Brief Summary

The primary objective of this study is to evaluate the efficacy of brodalumab, compared to placebo, in subjects with psoriatic arthritis.

Conditions

Psoriatic Arthritis

Keywords

Psoriatic Arthritis; Brodalumab; AMG 827

Outcome Measures

Primary Outcomes (1)

• American College of Rheumatology (ACR) 20 Response

  An ACR20 response is defined as at least 20% improvement of tender and swollen joint counts combined with at least 20% improvement in at least 3 of the following 5 parameters: Patients Global Assessment, PtGA of disease activity, patient's assessment of pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), and either Erythrocycte sedimentation rate (ESR) or C-Reactive protein (CRP) (ACR components).

  16 weeks

Secondary Outcomes (1)

• Psoriasis Area and Severity Index (PASI)75

  16 Weeks

Study Arms (3)

210 mg brodalumab

EXPERIMENTAL

Administered via subcutaneous injections

Drug: 210 mg brodalumab

140 mg brodalumab

EXPERIMENTAL

Administered via subcutaneous injection

Drug: 140 mg brodalumab

Placebo

PLACEBO COMPARATOR

Administered via subcutaneous injection until week 24.

Drug: Placebo

Interventions

210 mg brodalumab DRUG

210 mg brodalumab administered via subcutaneous injection

Also known as: AMG 827

210 mg brodalumab

140 mg brodalumab DRUG

140 mg brodalumab administered via subcutaneous injection

Also known as: AMG 827

140 mg brodalumab

Placebo DRUG

Placebo administered via subcutaneous injection until week 24.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (152)

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Huntsville, Alabama, 35801, United States

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Tuscaloosa, Alabama, 35406, United States

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Peoria, Arizona, 85381, United States

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Scottsdale, Arizona, 85258, United States

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Los Angeles, California, 90095, United States

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Mather, California, 95655, United States

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Murrieta, California, 92563, United States

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Palm Desert, California, 92260, United States

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Tustin, California, 92780, United States

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Upland, California, 91786, United States

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Jupiter, Florida, 33458, United States

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Tamarac, Florida, 33321, United States

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Tampa, Florida, 33613, United States

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Gainesville, Georgia, 30501, United States

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Meridian, Idaho, 83642, United States

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Springfield, Illinois, 62703, United States

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Bowling Green, Kentucky, 42101, United States

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Somerset, Kentucky, 42503, United States

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Frederick, Maryland, 21702, United States

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Wheaton, Maryland, 20902, United States

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Worcester, Massachusetts, 01605, United States

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Lansing, Michigan, 48910, United States

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Eagan, Minnesota, 55121, United States

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Omaha, Nebraska, 68114, United States

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Clifton, New Jersey, 07012, United States

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Great Neck, New York, 11021, United States

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Lake Success, New York, 11042, United States

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New York, New York, 10016, United States

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Plainview, New York, 11803, United States

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Asheville, North Carolina, 28803, United States

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Bend, Oregon, 97701, United States

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Portland, Oregon, 97239, United States

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Duncansville, Pennsylvania, 16635, United States

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Charleston, South Carolina, 29406, United States

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Hixson, Tennessee, 37343, United States

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Austin, Texas, 78731, United States

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Houston, Texas, 77074, United States

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San Antonio, Texas, 78232, United States

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Danville, Virginia, 24541, United States

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Seattle, Washington, 98104, United States

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Beckley, West Virginia, 25801, United States

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Bridgeport, West Virginia, 26330, United States

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Glendale, Wisconsin, 53217, United States

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Hasselt, 3500, Belgium

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Leuven, 3000, Belgium

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Plovdiv, 4002, Bulgaria

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Plovdiv, 4003, Bulgaria

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Sofia, 1612, Bulgaria

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Sofia, 1709, Bulgaria

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Varna, 9010, Bulgaria

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Calgary, Alberta, T2G 1B1, Canada

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Calgary, Alberta, T3A 2N1, Canada

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Toronto, Ontario, M5T 2S8, Canada

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Waterloo, Ontario, N2J 1C4, Canada

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Québec, Quebec, G1V 3M7, Canada

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Trois-Rivières, Quebec, G8Z 1Y2, Canada

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Brno, 611 41, Czechia

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Brno, 638 00, Czechia

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České Budějovice, 370 01, Czechia

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Ostrava-Trebovice, 722 00, Czechia

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Pardubice, 530 02, Czechia

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Prague, 128 50, Czechia

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Uherské Hradiště, 686 01, Czechia

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Pärnu, 80010, Estonia

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Tallinn, 10117, Estonia

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Cahors, 46005, France

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Orléans, 45067, France

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Rennes, 35203, France

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Saint-Etienne, 42055, France

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Toulouse, 31059, France

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Tours, 37044, France

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Athens, 11527, Greece

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Athens, 12462, Greece

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Athens, 16121, Greece

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Athens, 16673, Greece

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Heraklion, 71110, Greece

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Thessaloniki, 56429, Greece

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Budapest, 1036, Hungary

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Budapest, 1062, Hungary

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Debrecen, 4032, Hungary

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Esztergom, 2500, Hungary

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Nyíregyháza, 4400, Hungary

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Székesfehérvár, 8000, Hungary

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Szolnok, 5000, Hungary

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Florence, 50134, Italy

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Milan, 20122, Italy

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Pavia, 27100, Italy

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Roma, 00152, Italy

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Roma (RM), 00133, Italy

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Rome, 00144, Italy

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Verona, 37126, Italy

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Mexicali, Baja California Norte, 21100, Mexico

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Chihuahua City, Chihuahua, 31000, Mexico

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León, Guanajuato, 37520, Mexico

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Guadalajara, Jalisco, 44160, Mexico

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Guadalajara, Jalisco, 44620, Mexico

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Guadalajara, Jalisco, 44650, Mexico

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Distrito Federal, Mexico, 03100, Mexico

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Ciudad Obregón, Sonora, 85000, Mexico

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Mérida, Yucatán, 97133, Mexico

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Gdansk, 80-952, Poland

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Gdynia, 81-384, Poland

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Katowice, 40-040, Poland

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Lodz, 90-242, Poland

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Lodz, 90-436, Poland

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Lublin, 20-607, Poland

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Poznan, 61-113, Poland

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Stalowa Wola, 37-450, Poland

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Świdnik, 21-040, Poland

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Warsaw, 01-192, Poland

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Warsaw, 02-118, Poland

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Warsaw, 02-653, Poland

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Warsaw, 04-141, Poland

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Wroclaw, 50-088, Poland

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Wroclaw, 50-368, Poland

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Wroclaw, 51-318, Poland

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Moscow, 115522, Russia

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Moscow, 127473, Russia

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Nizhny Novgorod, 603005, Russia

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Nizhny Novgorod, 603126, Russia

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Novosibirsk, 630099, Russia

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Saint Petersburg, 190068, Russia

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Saratov, 410012, Russia

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Yaroslavl, 150062, Russia

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Yekaterinburg, 620102, Russia

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Banská Bystrica, 974 05, Slovakia

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Lučenec, 984 01, Slovakia

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Rimavská Sobota, 979 01, Slovakia

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Žilina, 01001, Slovakia

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Córdoba, Andalusia, 14004, Spain

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Granada, Andalusia, 18014, Spain

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Seville, Andalusia, 41009, Spain

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Barcelona, Catalonia, 08036, Spain

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Barcelona, Catalonia, 08041, Spain

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L'Hospitalet de Llobregat, Catalonia, 08907, Spain

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Sabadell, Catalonia, 08208, Spain

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Mérida, Extremadura, 06800, Spain

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A Coruña, Galicia, 15006, Spain

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Madrid, Madrid, 28007, Spain

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Madrid, Madrid, 28031, Spain

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Villajoyosa, Valencia, 03570, Spain

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Basel, 4031, Switzerland

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Geneva, 1211, Switzerland

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Lausanne, 1011, Switzerland

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Zurich, 8091, Switzerland

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Birmingham, B15 2TH, United Kingdom

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Glasgow, G31 2ER, United Kingdom

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Hull, HU3 2JZ, United Kingdom

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Leeds, LS7 4SA, United Kingdom

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London, E11 1NR, United Kingdom

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London, SE1 9RT, United Kingdom

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Manchester, M13 9WL, United Kingdom

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Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

brodalumab

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Valeant Pharmaceuticals

binu.alexander@valeant.com

908

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 8, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: May 19, 2017
• Results First Posted: May 19, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (7); HU (7); PL (16); GB (7); ME (9); RU (9); CZ (7); CA (6); ES (2); FR (6); US (43); CH (4); BE (2); BU (5); GR (6); SL (4)