Safety and Efficacy of AMG 827 in Subjects With RA
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: AMG 827
Intervention description: AMG 827 210 mg
Intervention MeSH terms: Brodalumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 211.0
Sex: All
Healthy volunteers: No
Keywords: Amgen; RA; AMG 827; 20090061

Summary:

      This is an extension study for subjects who participated in Protocol 20090061 (NCT00950989).
      All subjects in this study will receive a 210mg injection of AMG827 for treatment for their
      Rheumatoid Arthritis for up to 5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has provided informed consent.

          -  Subject was randomized into study 20090061 and completed the week 16 evaluation.

          -  Negative test for hepatitis B virus (HBV) surface antigen, hepatitis C virus (HCV)
             antibody, and/or human immunodeficiency virus (HIV) in subjects if clinically
             indicated (eg, known recent exposure) in the opinion of the investigator.

          -  Subject must test negative for Tuberculosis.

        Exclusion Criteria:

          -  Subject had any SAE reported during 20090061 that was considered to be related to IP.

          -  Subject is currently experiencing an infection of CTCAE grade 2 (if requiring oral
             antibiotics) or higher. Subject is ineligible until the infection is resolved in the
             opinion of the investigator.

          -  For subjects with > 4 weeks between the week 16 visit of 20090061 and the planned
             first IP dose in 20090402, subject has laboratory abnormalities at screening,
             including:

          -  Elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT); >1.5x
             upper limit of normal)

          -  Serum total bilirubin ≥1.5 mg/dL

          -  Hemoglobin < 11 g/dL

          -  Platelet count < 125,000 /mm3

          -  White blood cell count < 3,000 cells/mm3

          -  Absolute neutrophil count < 2000/mm3

          -  Estimated creatinine clearance < 50 mL/min (Cockroft-Gault formula, central lab will
             calculate value and provide to sites)

          -  Subject has a significant concurrent medical conditions, including:

          -  Type 1 diabetes

          -  Poorly controlled type 2 diabetes (Hemoglobin A1c > 8.5)

          -  Symptomatic heart failure (New York Heart Association class II, III, or IV)

          -  Myocardial infarction within the last year

          -  Current or history of unstable angina pectoris within the last year

          -  Uncontrolled hypertension as defined by resting blood pressure > 150/90 mmHg prior to
             first IP dose (confirmed by a repeat assessment)

          -  Severe chronic pulmonary disease (eg, requiring oxygen therapy)

          -  Major chronic inflammatory disease or connective tissue disease other than rheumatoid
             arthritis (eg, systemic lupus erythematosus), with the exception of secondary
             Sjögren's syndrome

          -  Multiple sclerosis or any other demyelinating disease

          -  Active malignancy, including evidence of cutaneous basal or squamous cell carcinoma or
             melanoma, or history of cancer (except successfully treated in situ cervical cancer or
             squamous or basal cell carcinoma of the skin)

          -  Any condition that, in the opinion of the investigator, might cause this study to be
             detrimental to the subject

          -  Subject is pregnant or breast feeding, or planning to become pregnant while enrolled
             in the study, up to the subject's last study visit including the follow-up period.

          -  Female subject is not willing to abstain from sexual intercourse or use 2 highly
             effective forms of birth control for the duration of the study and at least 40 days
             after the last dose (except women at least 3 years postmenopausal or surgically
             sterile). Highly effective methods of birth control for women include but are not
             limited to birth control pills, Depo Provera® injections, contraceptive implants, or
             occlusive cap (barrier method) in combination with barrier methods used by the man.

          -  Male subject is not willing to abstain from sexual intercourse or use 2 highly
             effective forms of birth control for the duration of the study, plus an additional 16
             weeks after the last dose (except for men who are surgically sterile or whose female
             partners are at least 3 years postmenopausal or surgically sterile). Highly effective
             methods of birth control include but are not limited to a condom in combination with
             hormonal birth control or barrier methods used by the woman.

          -  Male subject (including vasectomised males) with a pregnant female partner is not
             willing to use effective methods to ensure that an unborn child is not exposed to AMG
             827 via semen. Effective methods to ensure that an unborn child is not exposed to AMG
             827 via semen include condoms or abstinence.

          -  Subject has used any of the following within 14 days prior to IP initiation

          -  Non-biologic disease-modifying anti-rheumatic drugs (DMARD) other than as allowed in
             20090061

          -  Intra-articular, intramuscular, or intravenous corticosteroids, including
             adrenocorticotropic hormone

          -  Subject has used any of the following within 3 months prior to IP initiation

          -  Leflunomide

          -  Live vaccines

          -  Commercially available or experimental biologic DMARD except for AMG 827

          -  Subject has received gold therapy within 6 months prior to IP initiation.

          -  Subject received another investigational agent (other than AMG 827) or participated in
             an investigational device study subsequent to 20090061.

          -  Other investigational procedures are excluded.