Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
Rheumatoid Arthritis

About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Male or female between 18 to 70 years of age, inclusive at the time of screening
- Diagnosed with RA as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria
- Active RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) and at least 1 of the following:
- Erythrocyte sedimentation rate (ESR) ≥ 28 mm, or
- C-reactive protein (CRP) > 15 mg/L, or
- Morning stiffness > 45 minutes (applicable to subjects in Part A ONLY)
- Duration of RA for at least 6 months
- Currently taking methotrexate (MTX) consecutively for ≥ 12 weeks and on a stable dose of oral or SC MTX at 15-25 mg weekly for ≥ 4 weeks at day -1. A lower MTX dose is acceptable if it is the highest tolerated dose, however, toxicity documentation by the Investigator is required. All subjects will take folic acid to minimize toxicity, according to local guidelines.
- Additional Inclusion Criteria Apply
Exclusion Criteria:
- History or evidence of a clinically significant disorder other than RA (including but not limited to cardiopulmonary, oncologic, renal, metabolic, hematologic or psychiatric), condition or disease that, in the opinion of the Investigator and Amgen physician would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- Uncontrolled, clinically significant systemic disease other than RA such as diabetes mellitus, liver disease, asthma, cardiovascular disease or hypertension
- Malignancy within 5 years (except successfully treated in situ cervical cancer or squamous or basal cell carcinoma of the skin)
- Presence of a serious or chronic infections
- Subject (male or female) is not willing to use highly effective contraception, defined as a double barrier method (ie, spermicidal jelly and condom, or condom and diaphragm) during treatment and up to end of study
- Additional Exclusion Criteria Apply
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Placebo Comparator
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo SC (Cohorts 1-3)
Placebo IV (Cohorts 5-6)
Brodalumab 50 mg SC (Cohort 1)
Brodalumab 140 mg SC (Cohort 2)
Brodalumab 210 mg SC (Cohort 3)
Brodalumab 420 mg IV (Cohort 5)
Brodalumab 700 mg IV (Cohort 6)
Participants received placebo to brodalumab by subcutaneous (SC) injection once every 2 weeks for a total of six doses.
Participants received placebo to brodalumab by intravenous (IV) infusion every 4 weeks for a total of two doses.
Participants received 50 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
Participants received 140 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
Participants received 210 mg brodalumab by subcutaneous injection once every 2 weeks for a total of six doses.
Participants received 420 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.
Participants received 700 mg brodalumab by IV infusion once every 4 weeks for a total of two doses.