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Completed

NCT Number: NCT01683695

Safety Study of AMG 557 in Subjects With Lupus Arthritis

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.

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Key information

Conditions

Lupus Arthritis, Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, St Leonards, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMG 557

Drug

AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.

Matching Placebo

Drug

Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. Percentage change in the tender and swollen joint counts at Day 169 relative to baseline.

    Time frame: Day 169

  3. 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

  4. Proportion of subjects achieving reduction in and maintenance of prednisone (or its

    Time frame: Days 85-169

  5. Physician Global Assessment of Disease Activity (PGADA).

    Time frame: 330 days, including a 21-day screening period

  6. Subject Global Assessment of Disease Activity (SGADA).

    Time frame: 330 days, including a 21-day screening period

  7. Serum PK profile of AMG 557 after multiple dose administrations.

    Time frame: 330 days, including a 21-day screening period

  8. Proportion of subjects who discontinued immunosuppressants by Day 29 in subjects

    Time frame: Day 29

  9. Cumulative dose of prednisone (or its equivalent) from Day 85 to Day 169.

    Time frame: Day 85 to Day 169

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Sep 12, 2012
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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