drugset / Trial / NCT00520572

A 6-month Randomised, Double-blind, Open Arm Comparator, Phase IIb, With AZD9056, in Patients With Rheumatoid Arthritis (RA)

NCT00520572 ↗

Phase 2 Completed 385 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to confirm that AZD9056 is effective in treating rheumatoid arthritis with regard to signs and symptoms and to determine what dose is favourable over a 6-month treatment period. Patients will receive background treatment with either Methotrexate or Sulphasalazine

Timeline

Start
2007-08
Primary completion
—
Completion
2009-03

Outcome

Missed primary endpoint

paper no clinically or statistically significant effect on RA relative to placebo as measured by the proportion of patients meeting the ACR20 criteria at 6 months PMID 22966146 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject AZD9056 Small molecule 50 mg Oral
Subject AZD9056 Small molecule 100 mg Oral
Subject AZD9056 Small molecule 200 mg Oral
Subject AZD9056 Small molecule 400 mg Oral
Comparator Etanercept Protein / enzyme biologic 50 mg Subcutaneous

Indications