Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

AMG 827 in Subjects With Psoriatic Arthritis

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01516957
First received: August 18, 2011
Last updated: March 21, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Psoriatic Arthritis
Drug: AMG 827
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Amgen:

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 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

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 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • To evaluate the efficacy of AMG 827 in psoriatic arthritis as measured by Clinical Disease Activity Index (CDAI) change from baseline at week 12 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • To evaluate the safety of AMG 827 in psoriatic arthritis as measured by development of antibodies to AMG 827 [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]
  • To evaluate the safety of AMG 827 in psoriatic arthritis as measured by number of subjects with AE [ Time Frame: up to 5 years ] [ Designated as safety issue: Yes ]

Enrollment: 168
Study Start Date: October 2011
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AMG 827 SC 140 mg
140 mg AMG 827
Drug: AMG 827
140 mg AMG 827 SC (subcutaneous)
Placebo Comparator: Placebo SC
Placebo
Drug: Placebo
Placebo SC (subcutaneous)
Experimental: AMG 827 SC 280 mg
280 mg AMG 827
Drug: AMG 827
280 mg AMG 827 SC (subcutaneous)
Experimental: AMG 827 SC 210 mg
AMG 827 SC 210 mg
Drug: AMG 827
210 mg AMG 827 SC (subcutaneous)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01516957

  Show 31 Study Locations
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided by Amgen

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01516957     History of Changes
Other Study ID Numbers: 20101227
Study First Received: August 18, 2011
Last Updated: March 21, 2014
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Amgen:
Psoriatic Arthritis
IL-17
AMG 827
AMG827
Musculoskeletal Disease
Spondylarthropathy

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Bone Diseases
Joint Diseases
Musculoskeletal Diseases
Psoriasis
Skin Diseases
Skin Diseases, Papulosquamous
Spinal Diseases
Spondylarthritis
Spondylarthropathies
Spondylitis

ClinicalTrials.gov processed this record on November 24, 2014