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Completed Phase 1Phase 2 Interventional Results available

Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

ClinicalTrials.gov ID: NCT00669942

Public ClinicalTrials.gov record NCT00669942. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 6, 2026, 5:06 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT00669942
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1, Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
104 participants

Conditions and interventions

Interventions

Biological · Drug

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 30, 2005
Primary completion
Oct 31, 2008
Completion
Oct 31, 2008
Last update posted
Mar 29, 2015

2005 – 2008

United States locations

U.S. sites
12
U.S. states
9
U.S. cities
12
Facility City State ZIP Site status
Novartis Investigative Site Anniston Alabama 36207-5710
Novartis Investigative Site Tucson Arizona 85724
Novartis Investigative Site Largo Florida 33773
Novartis Investigative Site Ocala Florida 34471
Novartis Investigative Site Palm Harbor Florida 34684
Novartis Investigative Site Port Orange Florida 32127
Novartis Investigative Site Madisonville Kentucky 42431
Novartis Investigative Site St Louis Missouri 63110
Novartis Investigative Site Omaha Nebraska 68131-2197
Novartis Investigative Site Oklahoma City Oklahoma 73103
Novartis Investigative Site Bend Oregon 97701
Novartis Investigative Site Duncansville Pennsylvania 16635

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 12 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00669942, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Mar 29, 2015 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00669942 live on ClinicalTrials.gov.

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