CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
AIN457A +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/NCT01169844
NCT01169844Phase 2Completed

An Open Label Non-randomized Extension Study to Evaluate the Safety and Tolerability of AIN457 (Anti Interleukin-17 Monoclonal Antibody) in Patients With Psoriatic Arthritis

Novartis Pharmaceuticals·interventional·Posted Jul 26, 2010·Updated Jun 10, 2021

In Brief

A Phase 2 clinical trial evaluating AIN457A and Other for Psoriatic Arthritis. Completed, enrolled 28 participants across 6 sites in 3 countries.

Detailed Summary

This study is designed as an extension study to the proof-of-concept trial CAIN457A2206 in patients with psoriatic arthritis and aims to provide continuous treatment with AIN457 for patients in the core trial, to obtain safety and tolerability information. The study will address the evaluation of efficacy following doses of 3 mg/kg AIN457 given every 4 weeks over a period initially up to 6 months (Part 1) and based on the risk/benefit balance of AIN457 in psoriatic arthritis a decision will be made as to whether or not to continue dosing for another 6 month period (Part 2).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Netherlands, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2010
Enrollment StartJun 1, 2010
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 15.9 years ago

Interventions

AIN457Abiological

Otherother