At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 104 enrolled
Drug / intervention
AIN457 +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.
A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose
In Brief
A Phase 2 clinical trial evaluating AIN457 and Placebo for Rheumatoid Arthritis. Completed, enrolled 104 participants across 24 sites in 6 countries.
Detailed Summary
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Germany, Netherlands, Singapore, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedMay 2008
Primary CompletionNov 2008
TodayJul 2026
First PostedMay 1, 2008
Enrollment StartDec 1, 2005
Primary CompletionNov 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 18.2 years ago
Interventions
AIN457biological
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
Placebodrug
Placebo to AIN457