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

NCT ID: NCT00296257

Last Updated: 2009-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-02-28

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis (RA)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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SMP-114

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dainippon Sumitomo Pharma Europe LTd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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David Scott, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

Kings College Hospital

Locations

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Česká Lípa, , Czechia

Site Status

České Budějovice, , Czechia

Site Status

Hlučín, , Czechia

Site Status

Ostrava Trebovice, , Czechia

Site Status

Prague, , Czechia

Site Status

Prague, , Czechia

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Terezín, , Czechia

Site Status

Uherské Hradiště, , Czechia

Site Status

Zlín, , Czechia

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Bad Nauheim, , Germany

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Freiburg im Breisgau, , Germany

Site Status

Hildesheim, , Germany

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Leipzig, , Germany

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Ratingen, , Germany

Site Status

Zerbst, , Germany

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Békéscsaba, , Hungary

Site Status

Budapest, , Hungary

Site Status

Budapest, , Hungary

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Debrecen, , Hungary

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Debrecen, , Hungary

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Esztergom, , Hungary

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Kecskemét, , Hungary

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Komárom, , Hungary

Site Status

Miskolc, , Hungary

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Szombathely, , Hungary

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Groningen, , Netherlands

Site Status

JD Alkmaar, , Netherlands

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Rotterdam, , Netherlands

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Częstochowa, , Poland

Site Status

Elblag, , Poland

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Katowice, , Poland

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Lublin, , Poland

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Sopot, , Poland

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Swietokrzyce, , Poland

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Szczecin, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Birmingham, , United Kingdom

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Colchester, , United Kingdom

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Greenock, , United Kingdom

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Huddersfield, , United Kingdom

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London, , United Kingdom

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Maidstone, , United Kingdom

Site Status

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Middlesbrough, , United Kingdom

Site Status

Newcastle Upon Tyne and Wear, , United Kingdom

Site Status

Countries

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Czechia Germany Hungary Netherlands Poland United Kingdom

Other Identifiers

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D2450174

Identifier Type: -

Identifier Source: org_study_id

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