CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Brodalumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00771030
NCT00771030Phase 2Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Ascending Multiple-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of AMG 827 in Subjects With Rheumatoid Arthritis

Amgen·interventional·Posted Oct 10, 2008·Updated Nov 26, 2021

In Brief

A Phase 2 clinical trial evaluating Brodalumab and Placebo for Rheumatoid Arthritis. Completed, enrolled 40 participants.

Detailed 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 patients with active rheumatoid arthritis (RA) in combination with a stable dose of disease modulating anti-rheumatic drugs (DMARDs). Part A is dose escalation (to assess safety \& tolerability), and Part B is dose expansion (to assess clinical efficacy) at the highest tolerated dose level of brodalumab from Part A.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 10, 2008
Enrollment StartOct 27, 2008
Primary CompletionMay 25, 2010
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 17.7 years ago

Interventions

Brodalumabbiological

Solution for subcutaneous or intravenous administration

Placeboother

Solution for subcutaneous or intravenous administration