CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
AIN457 +1 morebiological
Likely dose
AIN457 50 mgfrom 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/NCT00809614
NCT00809614Phase 2Completed
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Randomized, Double-blind Placebo-controlled Multi-center Proof-of-concept Study to Assess the Efficacy of AIN457 in Patients With Psoriatic Arthritis

Novartis Pharmaceuticals·interventional·Posted Dec 17, 2008·Updated Nov 13, 2015

In Brief

A Phase 2 clinical trial evaluating AIN457 and Placebo for Psoriatic Arthritis. Completed, enrolled 42 participants across 10 sites in 3 countries.

Detailed Summary

This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis. The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses of AIN457 10 mg/kg administered three weeks apart.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2008
Enrollment StartMar 1, 2009
Primary CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.5 years ago

Interventions

AIN457biological

The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.

Placebobiological

Matching placebo to AIN457