Study of Efficacy, Safety and Effect on Radiographic Progession of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-1)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02029495
First received: January 6, 2014
Last updated: July 16, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: 210 mg brodalumab
Drug: 140 mg brodalumab
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • American College of Rheumatology (ACR) 20 response [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of brodalumab compared to placebo, in subjects with psoriatic arthritis.


Secondary Outcome Measures:
  • Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of brodalumab compared to placebo at week 16.

  • Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of brodalumab compared to placebo at week 16.

  • Psoriasis Symptom Inventory responder definition [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
    To evaluate the efficacy of brodalumab compared to placebo at week 16.

  • Van der Heijde modified Total Sharp score (mTSS) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]
    To evaluate the effect of brodalumab compared to placebo at week 24


Estimated Enrollment: 630
Study Start Date: March 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 210 mg brodalumab
Administered via subcutaneous injections
Drug: 210 mg brodalumab
210 mg brodalumab administered via subcutaneous injection
Experimental: 140 mg brodalumab
Administered via subcutaneous injection
Drug: 140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection
Placebo Comparator: Placebo
Administered via subcutaneous injection until week 24. At week 24, participants are assigned to 210 mg brodalumab.
Drug: Placebo
Placebo administered via subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029495

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 84 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02029495     History of Changes
Other Study ID Numbers: 20090406, 2013-003554-25
Study First Received: January 6, 2014
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Belgium: Federal Agency for Medicinal Products and Health Products
Czech Republic: State Institute for Drug Control
France: National Agency for Medicines and Health Products Safety (ANSM)
Greece: National Organization of Medicines (EOF)
Hungary: National Institute for Pharmacy
Italy: 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 Products
Russia: The Ministry of Healthcare of the Russian Federation (Minzdrav)
Spain: Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)
Switzerland: Swissmedic
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Amgen:
Psoriatic Arthritis
Brodalumab
AMG 827

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014