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Trial record 1 of 2 for:
brodalumab psoriatic
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis (AMVISION-2)
This study has been completed.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT02024646
First received: December 27, 2013
Last updated: June 8, 2016
Last verified: June 2016
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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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, 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:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Brodalumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- American College of Rheumatology (ACR) 20 Response [ Time Frame: 16 Weeks ]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 ]To evaluate the efficacy of brodalumab compared to placebo at week 16.
- Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: 16 Weeks ]To evaluate the efficacy of brodalumab compared to placebo at week 16.
- Psoriasis Symptom Inventory responder definition [ Time Frame: 16 Weeks ]To evaluate the efficacy of brodalumab compared to placebo at week 16.
| Enrollment: | 484 |
| Study Start Date: | March 2014 |
| Study Completion Date: | October 2015 |
| Primary Completion Date: | October 2015 (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.
Other Name: AMG 827
|
|
Experimental: 140 mg brodalumab
Administered via subcutaneous injection.
|
Drug: 140 mg brodalumab
140 mg brodalumab administered via subcutaneous injection.
Other Name: AMG 827
|
|
Placebo Comparator: Placebo
Administered via subcutaneous injection until week 24.
|
Drug: Placebo
Placebo administered via subcutaneous injection until week 24.
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
Show 103 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02024646
Show 103 Study Locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT02024646 History of Changes |
| Other Study ID Numbers: |
20110144 2013-003553-16 ( EudraCT Number ) |
| Study First Received: | December 27, 2013 |
| Last Updated: | June 8, 2016 |
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 Antibodies, Monoclonal Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017