Back to Search Results
Terminated/Withdrawn
Sponsor ID
20101227

AMG 827 in Subjects with Psoriatic Arthritis

Sponsor ID
20101227
Clinicaltrials.gov ID
NCT01516957
EUCTIS ID
N/A
EudraCT ID
N/A
Contact Us

Study Details

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.

Additional Study Details

Phase
Phase 2
Product
AMG 827
Type
Interventional
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Enrollment
168
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Baseline to week 12

Secondary Outcome Measures

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

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: Baseline to week 12

To evaluate the safety of AMG 827 in psoriatic arthritis as measured by development of antibodies to AMG 827

Timeframe: up to 5 years

To evaluate the safety of AMG 827 in psoriatic arthritis as measured by number of subjects with AE

Timeframe: up to 5 years

Study Documents

Study Synopsis
Available Language(s): English
Download Document(s)

Locations

Location
Status
Contact Us
Location
Research Site
Victoria, BC, Canada, V8P 5P6
Status
Recruiting
Location
Research Site
QC, QC, Canada, G1W 4R4
Status
Recruiting
Location
Research Site
Winnipeg, MB, Canada, R3A 1M3
Status
Recruiting
Location
Research Site
Ottawa, ON, Canada, K1H 8L6
Status
Recruiting
Location
Research Site
Quebec, QC, Canada, G1V 3M7
Status
Recruiting
Location
Research Site
Huntington Beach, CA, United States, 92646
Status
Recruiting
Showing {first} - {last} of {total} Results
Study Info
Age
18 - 75 Years
Condition
  • Psoriatic Arthritis
    • Sex
    All
    Trial Dates
    Oct 2011 - Sep 2012
    Inclusion and Exclusion Criteria
    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