A Proof of Concept and Dose Ranging Study in Patients with Rheumatoid Arthritis - ESCAPE
Study identifier:D1710C00009
ClinicalTrials.gov identifier:N/A
EudraCT identifier:N/A
CTIS identifier:N/A
Study Complete
Official Title
A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (with Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.
Medical condition
Rheumatoid Arthritis
Phase
Phase 2
Healthy volunteers
No
Study drug
AZD5672, Etanercept, Placebo
Sex
All
Actual Enrollment
373
Study type
Interventional
Age
18 Years +
Date
Study Start Date: 01 Jul 2008
Primary Completion Date: 01 Apr 2009
Study Completion Date: 01 Apr 2009
Study design
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verification:
Verified 01 Aug 2011 by AstraZeneca Pharmaceuticals
Sponsors
AstraZeneca Pharmaceuticals
Collaborators
-
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 | Drug: Etanercept 50 mg, subcutaneous injection, weekly Other Name: Enbrel |
| Experimental: 2 20mg | Drug: AZD5672 20 mg oral, once daily |
| Experimental: 3 50mg | Drug: AZD5672 50 mg oral, once daily |
| Experimental: 4 100mg | Drug: AZD5672 100 mg oral, once daily |
| Experimental: 5 150mg | Drug: AZD5672 150 mg oral, once daily |
| Placebo Comparator: 6 | Drug: Placebo placebo, oral, once daily |
Contacts
Investigators
Principal Investigator
Mark Layton
AstraZeneca
