drugset / Trial / NCT00713544
A Proof of Concept and Dose Ranging Study in Patients With Rheumatoid Arthritis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study is being carried out to investigate if AZD5672 is effective in treating Rheumatoid Arthritis (RA) and if so how it compares to placebo (a substance which does not have any action) and etanercept (a medicine already available to treat Rheumatoid Arthritis) when added to treatment with methotrexate. The purpose of this study is also to find out which dose of AZD5672 is the most effective at treating RA and to find out how well the body tolerates AZD5672 when taken for up to 12 weeks.
Timeline
- Start
- 2008-07
- Primary completion
- 2009-04
- Completion
- 2009-04
Outcome
Missed primary endpoint
paper There was no statistically significant difference in the proportion of patients achieving an ACR20 response at week 12 between those receiving PMID 20662070 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AZD5672 | Small molecule | 20 mg | Oral |
| Subject | AZD5672 | Small molecule | 50 mg | Oral |
| Subject | AZD5672 | Small molecule | 100 mg | Oral |
| Subject | AZD5672 | Small molecule | 150 mg | Oral |
| Comparator | Etanercept | Protein / enzyme biologic | 50 mg | Subcutaneous |