Efficacy, Safety and Tolerability of AIN457 in Patients With Rheumatoid Arthritis (RA) Taking Methotrexate (MTX)

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

This study will assess at Week 16 the efficacy and safety of AIN457 at different doses in patients with active RA despite stable MTX therapy. Treatment will continue up to Week 48 with a safety follow-up at Week 60 to assess the long term efficacy and safety of AIN457 treatment in combination with MTX in RA.

Key facts

Study ID

NCT00928512

Run by

Novartis Pharmaceuticals

People needed

237

Starts

2009-07-01

Expected to finish

2011-03-01

Last updated by the study team

2015-10-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presence of RA classified by ACR 1987 revised criteria. Patients with active RA should have been on MTX for at least 3 months and must currently be treated with a stable dose of MTX (> or =7.5 mg/week - < or = 25 mg/week) for at least 4 weeks
• At Baseline: Disease activity criteria defined by > or = 6 out of 28 tender joints and > or = 6 out of 28 swollen joints WITH either Screening value of hsCRP > or = 10 mg/L OR ESR > or = 28 mm/1st hr

You may not qualify if…

• RA patients functional status class IV classified according to the ACR 1991 revised criteria
• Patients taking high potency opioid analgesics (e.g., methadone, hydromorphone, or morphine)
• Any therapy by intra-articular injections (e.g. corticosteroid) required for treatment of acute RA flare within 4 weeks before randomization
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Peoria, Arizona, United States
• Novartis Investigative Site — Little Rock, Arkansas, United States
• Novartis Investigative Site — Santa Monica, California, United States
• Novartis Investigative Site — Coeur d'Alene, Idaho, United States
• Novartis Investigative Site — Springfield, Illinois, United States
• Novartis Investigative Site — Kalamazoo, Michigan, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Rochester, New York, United States
• Novartis Investigative Site — Oklahoma City, Oklahoma, United States
• Novartis Investigative Site — Tulsa, Oklahoma, United States
• Novartis Investigative Site — Greenville, South Carolina, United States
• Novartis Investigative Site — Jackson, Tennessee, United States
• Novartis Investigative Site — Brussels, Belgium
• Novartis Investigative Site — Ostrava, Czech Republic, Czechia
• Novartis Investigative Site — Pardubice, Czech Republic, Czechia
• Novartis Investigative Site — Uherské Hradiště, Czech Republic, Czechia
• Novartis Investigative Site — Prague, Czechia
• Novartis Investigative Site — Bayreuth, Germany
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hamburg, Germany
• Novartis Investigative Site — Hildesheim, Germany
• Novartis Investigative Site — München, Germany
• Novartis Investigative Site — Budapest, Hungary
• Novartis Investigative Site — Mesa, Arizona, United States

Full record on ClinicalTrials.gov

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