AMG 827 in Subjects With Psoriatic Arthritis

August 19, 2020 updated by: Bausch Health Americas, Inc.

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.

The study will examine the safety and effectiveness of AMG 827 for the treatment of psoriatic arthritis

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • QC, Canada, G1W 4R4
        • Research Site
      • Quebec, Canada, G1V 3M7
        • Research Site
    • British Columbia
      • Victoria, British Columbia, Canada, V8P 5P6
        • Research Site
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M3
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1C 5B8
        • Research Site
      • St. John's, Newfoundland and Labrador, Canada, A1A 5E8
        • Research Site
    • Ontario
      • Newmarket, Ontario, Canada, L3Y 3R7
        • Research Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Research Site
    • Quebec
      • Trois-Rivieres, Quebec, Canada, G8Z 1Y2
        • Research Site
  • United States
    • Arizona
      • Peoria, Arizona, United States, 85381
        • Research Site
      • Scottsdale, Arizona, United States, 85258
        • Research Site
      • Tucson, Arizona, United States, 85711
        • Research Site
    • California
      • Hemet, California, United States, 92543
        • Research Site
      • Huntington Beach, California, United States, 92646
        • Research Site
      • La Jolla, California, United States, 92037
        • Research Site
      • Los Angeles, California, United States, 90095
        • Research Site
      • Palm Desert, California, United States, 92260
        • Research Site
      • Palo Alto, California, United States, 94304
        • Research Site
      • Victorville, California, United States, 92395
        • Research Site
    • Florida
      • Sarasota, Florida, United States, 34239
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Research Site
    • Maryland
      • Frederick, Maryland, United States, 21702
        • Research Site
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Research Site
      • Lansing, Michigan, United States, 48910
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Research Site
    • New York
      • Rochester, New York, United States, 14642
        • Research Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98122
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AMG 827 140
140 mg AMG 827
Drug: AMG 827 140
140 mg AMG 827 SC (subcutaneous)
Placebo Comparator: Placebo SC
Placebo
Drug: Placebo
Placebo SC (subcutaneous)
Experimental: AMG 827 280
280 mg AMG 827
Drug: AMG 827 280
280 mg AMG 827 SC (subcutaneous)
Experimental: AMG 827 210
AMG 827 SC 210 mg
Drug: AMG 827 210
210 mg AMG 827 SC (subcutaneous)

What is the study measuring?

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%
Time Frame: Baseline to week 12
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
Time Frame: Baseline to week 12
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
Time Frame: 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 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)
Time Frame: Baseline to week 12

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)
Time Frame: Baseline to week 12

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:

  1. count the number of swollen joints (out of the 28),
  2. count the number of tender joints (out of the 28),
  3. take blood to measure the erythrocyte sedimentation rate (ESR) or C reactive protein (CRP),
  4. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

August 18, 2011

First Submitted That Met QC Criteria

January 19, 2012

First Posted (Estimate)

January 25, 2012

Study Record Updates

Last Update Posted (Actual)

August 27, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20101227

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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