Trials / Terminated
TerminatedNCT00296257
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
A Phase 2, Multi-Centre, Randomised, Double Blind, Placebo Controlled Study Evaluating the Efficacy, Safety and Pharmacokinetics of Two Doses of a Candidate Disease Modifying Anti-Rheumatic Drug (DMARD), (SMP-114 120 mg and 240 mg Once Daily), Administered in Combination With Ongoing Methotrexate Treatment in Patients With Active Rheumatoid Arthritis.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 312 (actual)
- Sponsor
- Dainippon Sumitomo Pharma Europe LTd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To compare the efficacy of SMP-114 (120 and 240 mg/d) versus placebo in terms of the percentage of patients meeting the American College of Rheumatology criteria for 20% improvement in RA (ACR20) at week 24. The study hypothesis would be to demonstrate that the use of methotrexate and SMP-114 is more efficacious than Methotrexate alone.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SMP-114 |
Timeline
- Start date
- 2006-02-01
- Completion
- 2008-04-01
- First posted
- 2006-02-24
- Last updated
- 2009-03-13
Locations
46 sites across 6 countries: Czechia, Germany, Hungary, Netherlands, Poland, United Kingdom
Source: ClinicalTrials.gov record NCT00296257. Inclusion in this directory is not an endorsement.