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Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate

NCT00950989 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2021-12-21

Study results available
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Summary

Study in participants with RA who have an inadequate response to methotrexate.

Conditions

Interventions

DRUG

Brodalumab

3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

DRUG

Placebo

3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

DRUG

Methotrexate

Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.

DIETARY_SUPPLEMENT

folic acid

at least 5 mg per week

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-30
Primary Completion
2011-02-11
Completion
2011-02-11

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Entities

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00950989 on ClinicalTrials.gov