AMG 827 in Subjects With Psoriatic Arthritis

Psoriatic Arthritis Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01516957
• Other study ID #: 20101227
• Status: Terminated
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: September 2015

Study information

• Verified date: August 2020
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 168
• Est. completion date: September 2015
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis

Intervention

Drug:
• AMG 827 140
140 mg AMG 827 SC (subcutaneous)
• Placebo
Placebo SC (subcutaneous)
• AMG 827 280
280 mg AMG 827 SC (subcutaneous)
• AMG 827 210
210 mg AMG 827 SC (subcutaneous)

Locations

Country	Name	City	State
Canada	Research Site	Newmarket	Ontario
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	QC
Canada	Research Site	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Trois-Rivieres	Quebec
Canada	Research Site	Victoria	British Columbia
Canada	Research Site	Winnipeg	Manitoba
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Boise	Idaho
United States	Research Site	Duncansville	Pennsylvania
United States	Research Site	Frederick	Maryland
United States	Research Site	Grand Rapids	Michigan
United States	Research Site	Hemet	California
United States	Research Site	Huntington Beach	California
United States	Research Site	La Jolla	California
United States	Research Site	Lansing	Michigan
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Lexington	Kentucky
United States	Research Site	Los Angeles	California
United States	Research Site	Palm Desert	California
United States	Research Site	Palo Alto	California
United States	Research Site	Peoria	Arizona
United States	Research Site	Portland	Oregon
United States	Research Site	Rochester	New York
United States	Research Site	Sarasota	Florida
United States	Research Site	Scottsdale	Arizona
United States	Research Site	Seattle	Washington
United States	Research Site	Tucson	Arizona
United States	Research Site	Victorville	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Mease PJ, Genovese MC, Greenwald MW, Ritchlin CT, Beaulieu AD, Deodhar A, Newmark R, Feng J, Erondu N, Nirula A. Brodalumab, an anti-IL17RA monoclonal antibody, in psoriatic arthritis. N Engl J Med. 2014 Jun 12;370(24):2295-306. doi: 10.1056/NEJMoa1315231. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   AmgenTrials clinical trials website