AMG 827 in Subjects With Psoriatic Arthritis

Study Overview
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Brief Summary
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The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Detailed Description
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The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis. Patients will randomly receive either AMG 827 or placebo (a look-a-like liquid that does not have any drug in it) and neither the doctor nor the patient will know what treatment is being given.

Official Title
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A Randomized, Double-blinded, Placebo-controlled, Multiple-dose Study With an Open Label Extension to Evaluate the Safety and Efficacy of AMG 827 in Subjects With Psoriatic Arthritis.

Conditions
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Psoriatic Arthritis

Intervention / Treatment
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* Drug: AMG 827 140
* Drug: Placebo
* Drug: AMG 827 280
* Drug: AMG 827 210


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has had a diagnosis of psoriatic arthritis (by the Classification of Psoriatic Arthritis (CASPAR) criteria) for at least 6 months Subject has ≥ 3 tender and ≥ 3 swollen joints Exclusion Criteria: Subject has an active infection or history of infections (systemic anti-infectives were used within 28 days; requiring hospitalization or intravenous anti-infectives within 8 weeks; recurrent or chronic) Significant concurrent medical conditions Pregnant or breast feeding Significant Laboratory abnormalities Use of sulfasalazine, hydroxychloroquine, systemically administered calcineurin inhibitors, azathioprine, parenteral corticosteroids including intramuscular or intraarticular administration, or live vaccines within 28 days Use of anti-TNF therapy within 2 months Use of an anti-interleukin (IL)12/IL-23 drug or other experimental or commercially available biologic therapies for psoriasis and/or psoriatic arthritis within 3 months Prior use of rituximab Prior use of anti-IL-17 biologic therapy, including AMG 827

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 827 140<br>140 mg AMG 827 | Drug: AMG 827 140<br>* 140 mg AMG 827 SC (subcutaneous)<br>|
| Placebo Comparator: Placebo SC<br>Placebo | Drug: Placebo<br>* Placebo SC (subcutaneous)<br>|
| Experimental: AMG 827 280<br>280 mg AMG 827 | Drug: AMG 827 280<br>* 280 mg AMG 827 SC (subcutaneous)<br>|
| Experimental: AMG 827 210<br>AMG 827 SC 210 mg | Drug: AMG 827 210<br>* 210 mg AMG 827 SC (subcutaneous)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an American College of Rheumatology (ACR) 20% | To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an American College of Rheumatology (ACR) 20% response at week 12. ACR20 responders are subjects with 20% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index. | Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 50 | To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 50 response at week 12. ACR50 responders are subjects with 50% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index. | Baseline to week 12 | 
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by the Proportion of Subjects Achieving an ACR 70 | To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by the proportion of subjects achieving an ACR 70 response at Week 12. ACR70 responders are subjects with 70% improvement from baseline based off of percent changes in tender/painful joint count, swollen joint counts, physician global assessment of disease activity, and health assessment questionnaire-disability index. | Baseline to week 12 | 
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Clinical Disease Activity Index (CDAI) | To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12. CDAI = SJC(28) + TJC(28) + PGA + EGA SJC(28): Swollen 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) TJC(28): Tender 28-Joint Count (shoulders, elbows, wrists, MCPs, PIPs including thumb IP, knees) PGA: Patient Global disease Activity (patient's self assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) A CDAI reduction of 6.5 represents moderate improvement. EGA: Evaluator's Global disease Activity (evaluator's assessment of overall RA disease activity on a scale 1-10 where 10 is maximal activity) | Baseline to week 12 | 
| To Evaluate the Efficacy of AMG 827 in Psoriatic Arthritis as Measured by Change From Baseline in Disease Activity Score With a 28 Joint Count (DAS 28) | To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Disease Activity Score with a 28 joint count (DAS 28) change from baseline at week 12. The DAS28 is a composite score derived from 4 measures. To calculate the DAS28: count the number of swollen joints (out of the 28), count the number of tender joints (out of the 28), take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP), ask the participant to make a 'global assessment of health' (indicated by marking a 10 cm line between very good and very bad). These results are then fed into a complex mathematical formula to produce the overall disease activity score. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission. | Baseline to week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psoriatic Arthritis, IL-17, AMG 827, AMG827, Musculoskeletal Disease, Spondylarthropathy