Psoriatic Arthritis MedDRA version: 14.1 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859
Conditions
Sponsors
Amgen Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent - Subject is = 18 years of age at time of screening - Subject has had a diagnosis of psoriatic arthritis for at least 6 months and currently meets the CASPAR criteria - Subject has = 3 tender and = 3 swollen joints - Subject has a history of intolerance or inadequate response to NSAIDs and/or DMARDs for psoriatic arthritis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 470 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Other Medical Conditions: - 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. Washouts or Other Treatments - Subject has used commercially available or investigational biologic therapies for psoriasis and/or psoriatic arthritis as follows: • anti-tumor necrosis factor (TNF) therapy within 2 months prior to investigational product initiation • other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months prior to investigational product initiation • anti-IL17 or anti-IL12/IL23 biologic therapy, including brodalumab, secukinumab, ixekizumab, ustekinumab, briakinumab at any time • rituximab at any time General - Subject is currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(s) prior to screening. - Other investigational procedures while participating in this study are excluded. - Subject has known sensitivity to any of the products or components to be administered during dosing. - Women of reproductive potential who are not willing to use an acceptable form of birth control during the study and for an additional 8 weeks after the last dose of study drug. - Women who are lactating/breastfeeding or planning to breastfeed during the study and for an additional 8 weeks after the last dose of Amgen study drug.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary Endpoints: PASI 75 at week 16 HAQ-DI change from baseline at week 16 Psoriasis Symptom Inventory responder definition (total score = 8 with no item score > 1) at week 16;Timepoint(s) of evaluation of this end point: PASI 75 at week 16 HAQ-DI change from baseline at week 16 Psoriasis Symptom Inventory responder definition (total score = 8 with no item score > 1) at week 16 | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of brodalumab, (210 mg every 2 weeks (Q2W); and 140 mg Q2W) compared to placebo, in subjects with psoriatic arthritis, as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20 response at week 16.;Secondary Objective: Key Secondary Objectives: To evaluate the efficacy of brodalumab compared to placebo at week 16 on the following: ? Psoriasis Area and Severity Index (PASI) 75 ? Health Assessment Questionnaire-Disability Index (HAQ-DI) ? Psoriasis Symptom Inventory responder definition;Primary end point(s): ACR20 response at week 16;Timepoint(s) of evaluation of this end point: Week 16 | — |
Countries
Australia, Canada, France, Germany, Greece, Hungary, Latvia, Mexico, Poland, Russian Federation, United States
Contacts
Public ContactIHQ Medical Info - Clinical Trials
Amgen (EUROPE) GmbH
Outcome results
None listed