Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114

Rheumatoid Arthritis (RA) Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00296257
• Other study ID #: D2450174
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2006
• Last updated: March 12, 2009
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: March 2009
• Source: Dainippon Sumitomo Pharma Europe LTd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory AgencyGermany: Federal Institute for Drugs and Medical DevicesPoland: Urzad Rejestracji Produktow LeczniczychCzech Republic: State Institute for Drug ControlNetherlands:Central Committee on Research Involving Human SubjectsHungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 312
• Est. completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female patients aged at least 18 years, with RA for a minimum of 6 months

• Has been receiving methotrexate treatment (stable for 8 weeks)

• Has active disease classified as ACR functional class of I, II or III

Exclusion Criteria:

• Has previously discontinued DMARD therapy due to hepatic intolerance

• Has received any DMARD in addition to methotrexate during the 4 weeks prior to randomisation

• Is receiving more than 2 DMARDs in addition to methotrexate at the time of screening

• Is receiving or has received Gold, leflunomide or biological agents including TNF/IL-1 inhibitors within the 8 weeks prior to randomisation

• Has previously failed 2 or more DMARDS

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• SMP-114

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Dainippon Sumitomo Pharma Europe LTd.

Countries where clinical trial is conducted

Czech Republic,  Germany,  Hungary,  Netherlands,  Poland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Secondary	To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
Secondary	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