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

Phase 2TerminatedNCT00296257

Dainippon Sumitomo Pharma Europe LTd.312 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

312

Conditions

Rheumatoid Arthritis (RA)

Interventions

SMP-114DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (46)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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Unnamed facility

Česká Lípa, Czechia

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České Budějovice, Czechia

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Hlučín, Czechia

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Ostrava Trebovice, Czechia

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Prague, Czechia

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Prague, Czechia

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Terezín, Czechia

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Uherské Hradiště, Czechia

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Zlín, Czechia

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Bad Nauheim, Germany

...and 36 more locations