Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02024646
First received: December 27, 2013
Last updated: August 6, 2014
Last verified: August 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. 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 and Safety of Brodalumab in Subjects With Psoriatic Arthritis: AMVISION-2

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.


Estimated Enrollment: 495
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:

Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal interphalangeal joints). Subjects must have at least

1 psoriatic skin lesion. 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: NCT02024646

Contacts
Contact: Amgen Call Center 866-572-6436

  Show 78 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT02024646     History of Changes
Other Study ID Numbers: 20110144, 2013-003553-16
Study First Received: December 27, 2013
Last Updated: August 6, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Latvia: State Agency of Medicines
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
France: National Agency for Medicines and Health Products Safety (ANSM)
Germany: Paul-Ehrlich-Institut
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Mexico: Federal Commission for Protection Against Health Risks
Russia: Ministry of Health of the Russian Federation

Keywords provided by Amgen:
Psoriatic Arthritis
Brodalumab
AMG 827

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

ClinicalTrials.gov processed this record on September 18, 2014