Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
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|ClinicalTrials.gov Identifier: NCT00296257|
Recruitment Status : Terminated
First Posted : February 24, 2006
Last Update Posted : March 13, 2009
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis (RA)||Drug: SMP-114||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||312 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||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.|
|Study Start Date :||February 2006|
|Actual Study Completion Date :||April 2008|
- To compare the efficacy of SMP-114 versus placebo in terms of the percentage of patients meeting the ACR criteria for 20% improvement in RA (ACR20) at Week 24.
- To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
- To compare the efficacy of SMP-114 versus placebo in terms of change in core variables, time to response, Quality of Life, radiological measurements of joint damage, assessment of safety and tolerability, and PK measurements
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296257
Show 47 Study Locations
|Principal Investigator:||David Scott, MD, FRCP||Kings College Hospital|