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Safety Study of AMG 557 in Subjects With Lupus Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01683695
Recruitment Status : Completed
First Posted : September 12, 2012
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Amgen

Tracking Information
First Submitted Date  ICMJE March 14, 2012
First Posted Date  ICMJE September 12, 2012
Last Update Posted Date January 24, 2017
Study Start Date  ICMJE June 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • 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 ]
  • Lupus Arthritis Response Rate [ Time Frame: Day 169 ]
    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
Original Primary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • 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 ]
  • Lupus Arthritis Response Rate [ Time Frame: Day 169 ]
    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) on ≤ 7.5 mg/d of prednisone or its equivalent from Day 85 to Day 169)
Change History Complete list of historical versions of study NCT01683695 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
  • 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 ]
  • Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. [ Time Frame: Day 169 ]
  • 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 ]
  • Proportion of subjects achieving reduction in and maintenance of prednisone (or its [ Time Frame: Days 85-169 ]
  • Physician Global Assessment of Disease Activity (PGADA). [ Time Frame: 330 days, including a 21-day screening period ]
  • Subject Global Assessment of Disease Activity (SGADA). [ Time Frame: 330 days, including a 21-day screening period ]
  • Serum PK profile of AMG 557 after multiple dose administrations. [ Time Frame: 330 days, including a 21-day screening period ]
  • Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects [ Time Frame: Day 29 ]
  • Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169. [ Time Frame: Day 85 to Day 169 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 10, 2012)
  • 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 ]
  • Percentage change in the tender and swollen joint counts at Day 169 relative to baseline. [ Time Frame: Day 169 ]
  • Proportion of subjects on ≤ 7.5 mg/day of prednisone (or equivalent) by Day 85, by treatment group. [ Time Frame: Day 85 ]
  • Cumulative dose of prednisone (or equivalent) from Day 85 to Day 169. [ Time Frame: Days 85-169 ]
  • Physician Global Assessment of Disease Activity (PGADA). [ Time Frame: 330 days, including a 21-day screening period ]
  • Subject Global Assessment of Disease Activity (SGADA). [ Time Frame: 330 days, including a 21-day screening period ]
  • Serum PK profile of AMG 557 after multiple dose administrations. [ Time Frame: 330 days, including a 21-day screening period ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of AMG 557 in Subjects With Lupus Arthritis
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Lupus Arthritis, Systemic Lupus Erythematosus
Intervention  ICMJE
  • Drug: AMG 557
    AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
  • Drug: Matching Placebo
    Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AMG 557
  • 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.
    Intervention: Drug: Matching Placebo
Publications * Cheng LE, Amoura Z, Cheah B, Hiepe F, Sullivan BA, Zhou L, Arnold GE, Tsuji WH, Merrill JT, Chung JB. Brief Report: A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multiple-Dose Study to Evaluate AMG 557 in Patients With Systemic Lupus Erythematosus and Active Lupus Arthritis. Arthritis Rheumatol. 2018 Jul;70(7):1071-1076. doi: 10.1002/art.40479. Epub 2018 May 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2015)
20
Original Estimated Enrollment  ICMJE
 (submitted: September 10, 2012)
40
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Denmark,   France,   Germany,   Malaysia,   Taiwan,   United Kingdom,   United States
Removed Location Countries Singapore
 
Administrative Information
NCT Number  ICMJE NCT01683695
Other Study ID Numbers  ICMJE 20101103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP