Safety Study of AMG 557 in Subjects With Lupus Arthritis

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Amgen
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01683695
First received: March 14, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

This is a multicenter, randomized, double-blind, parallel, placebo-controlled, multiple dose study that will enroll approximately 40 systemic lupus erythematosus subjects with active lupus arthritis.


Condition Intervention Phase
Lupus Arthritis, Systemic Lupus Erythematosus
Drug: AMG 557
Drug: Matching Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Parallel, Placebo-controlled, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Clinical Effect of AMG 557 in Systemic Lupus Erythematosus (SLE) Subjects With Active Lupus Arthritis

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Treatment-emergent adverse events, vital signs, physical examinations, clinical laboratory tests, ECGs, and the incidence of binding and neutralizing antibodies to AMG 557. [ Time Frame: 330 days, including a 21-day screening period ] [ Designated as safety issue: Yes ]
  • Lupus Arthritis Response Rate [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
    Defined by: 1) achieving at least a 50% decrease in the combined tender and swollen joint count compared to baseline at Day 169; 2) achieving one letter improvement in the Musculoskeletal System BILAG at Day 169 compared to baseline; 3) reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 50% of baseline corticosteroid dose (Day 1 predose) or ≤ 7.5 mg/day, whichever is lower, from Day 85 to Day 169 in subjects not treated with immunosuppressants at baseline, or reduction in and maintenance of prednisone (or its equivalent) dose to ≤ 7.5 mg/day from Day 85 to Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline


Secondary Outcome Measures:
  • Proportion of subjects achieving a) one letter improvement; and b) 'C' or better score in the Musculoskeletal system from BILAG index at Day 169 compared to baseline, by treatment group. [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. [ Time Frame: Day 169 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving reduction in and maintenance ≤ 7.5 mg/day of prednisone (or equivalent) from Day 85- Day 169 and discontinuation of immunosuppressants by Day 29 in subjects treated with immunosuppressants at baseline. [ Time Frame: Days 85-169 ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving reduction in and maintenance of prednisone (or its [ Time Frame: Days 85-169 ] [ Designated as safety issue: No ]
  • Physician Global Assessment of Disease Activity (PGADA). [ Time Frame: 330 days, including a 21-day screening period ] [ Designated as safety issue: No ]
  • Subject Global Assessment of Disease Activity (SGADA). [ Time Frame: 330 days, including a 21-day screening period ] [ Designated as safety issue: No ]
  • Serum PK profile of AMG 557 after multiple dose administrations. [ Time Frame: 330 days, including a 21-day screening period ] [ Designated as safety issue: No ]
  • Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
  • Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169. [ Time Frame: Day 85 to Day 169 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: AMG 557
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
Drug: AMG 557
AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Placebo Comparator: AMG 557 Matching Placebo
All will receive AMG 557 on Day 1, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, Day 85, Day 99, Day 113, Day 127, Day 141 and Day 155.
Drug: Matching Placebo
Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of SLE for at least 6 months as defined by the most recent American College of Rheumatology criteria
  • Presence of lupus related inflammatory arthritis with at least four tender and four swollen joints; and Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) ≥ 6 at screening;
  • Other inclusion criteria may apply.

Exclusion Criteria:

  • Presence or history of vasculitis, and presence or history of active lupus nephritis requiring therapy within the last 3 years
  • Any disorder (including psychiatric), condition, clinically significant disease, disease activity related to SLE
  • Positive for HIV antibodies, hepatitis B surface antigen or anti-HBc, or hepatitis C antibodies
  • Known residential exposure to an individual with tuberculosis or positive Quantiferon test or PPD test at screening
  • Men and women of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study
  • Other exclusion criteria may apply
  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: NCT01683695

Contacts
Contact: Amgen Call Center 866-572-6436

Locations
United States, California
Research Site Recruiting
San Leandro, California, United States, 94578
United States, Connecticut
Research Site Recruiting
Danbury, Connecticut, United States, 06810
United States, New York
Research Site Recruiting
Manhasset, New York, United States, 11030
Australia, New South Wales
Research Site Recruiting
St Leonards, New South Wales, Australia, 2065
Denmark
Research Site Recruiting
Odense, Denmark, 5000
France
Research Site Recruiting
Lille cedex 01, France, 59037
Research Site Recruiting
Paris Cedex 13, France, 75651
Germany
Research Site Recruiting
Berlin, Germany, 10117
Malaysia
Research Site Recruiting
Ipoh, Perak, Malaysia, 30990
Research Site Recruiting
Kuching, Sarawak, Malaysia, 93586
Research Site Recruiting
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 59100
Taiwan
Research Site Recruiting
Kaohsiung, Taiwan, 833
Research Site Recruiting
Taipei, Taiwan, 10002
United Kingdom
Research Site Recruiting
Birmingham, United Kingdom, B18 7QH
Research Site Recruiting
London, United Kingdom, WC1E 6JF
Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT01683695     History of Changes
Other Study ID Numbers: 20101103
Study First Received: March 14, 2012
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
Lupus Arthritis, Systemic Lupus Erythematosus, AMG 557, Lupus

Additional relevant MeSH terms:
Arthritis
Lupus Erythematosus, Systemic
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 20, 2014