Status:
COMPLETED
Study to Evaluate the Safety, PK, PD and Efficacy of AMG 827 in Adults With Rheumatoid Arthritis
Lead Sponsor:
Amgen
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This Phase 1b/2a study will evaluate safety, tolerability pharmacokinetics (PK) and pharmacodynamics (PD) of brodalumab when administered in multiple subcutaneous (SC) and intravenous (IV) doses in pa...
Detailed Description
The dose-escalation phase consisted of 5 sequentially enrolled dose cohorts. Within each cohort participants were randomly assigned in a 3:1 ratio to receive brodalumab or placebo subcutaneously (coho...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 25 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00771030
Start Date
October 27 2008
End Date
May 25 2010
Last Update
November 26 2021
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