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

March 12, 2009 updated by: Dainippon Sumitomo Pharma Europe LTd.

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.

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

312

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Czech Republic
      • Ceska Lipa, Czech Republic, 470 01
      • Ceske Budejovice, Czech Republic, 370 00
      • Hlucin, Czech Republic, 748 01
      • Ostrava Trebovice, Czech Republic, 722 00
      • Prague 2, Czech Republic, 128 50
      • Praha 5, Czech Republic, 158 00
      • Terezin, Czech Republic, 411 55
      • Uherske Hradiste, Czech Republic, 686 01
      • Zlin, Czech Republic, 760 01
  • Germany
      • Bad Nauheim, Germany, 61231
      • Freiburg, Germany, 79106
      • Hildesheim, Germany, 31134
      • Leipzig, Germany, 04103
      • Ratingen, Germany, 40882
      • Zerbst, Germany, 3923
  • Hungary
      • Bekescsaba, Hungary, H5600
      • Budapest, Hungary, H 1023
      • Budapest, Hungary, H1023
      • Debrecen, Hungary, H 4004
      • Debrecen, Hungary, H 4043
      • Esztergom, Hungary, H2500
      • Kecskemet, Hungary, H6000
      • Komarom, Hungary
      • Miskolc, Hungary, H 3529
      • Szombathely, Hungary, H 9700
  • Netherlands
      • Groningen, Netherlands, 9713
      • JD Alkmaar, Netherlands, 1815
      • Rotterdam, Netherlands, 3078
  • Poland
      • Czestochowa, Poland
      • Elbląg, Poland, 82-300
      • Katowice, Poland, 40-635
      • Lublin, Poland, 20-022
      • Sopot, Poland, 81-759
      • Swietokrzyce, Poland, 26-200
      • Szczecin, Poland, 71-252
      • Warsaw, Poland, 02-637
      • Warszawa, Poland, 02-637
      • Warszawa, Poland, 00-909
  • United Kingdom
      • Birmingham, United Kingdom, B29 6JD
      • Colchester, United Kingdom, CO4 5JL
      • Greenock, United Kingdom, PA16 0XN
      • Huddersfield, United Kingdom, HD3 3EA
      • London, United Kingdom, SE5 9PJ
      • Maidstone, United Kingdom, ME16 9QQ
      • Middlesborough, United Kingdom, TS4 3BW
      • Newcastle upon Tyne and Wear, United Kingdom, NE7 7DN
      • Wirral, United Kingdom, CH49 5PE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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 Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dainippon Sumitomo Pharma Europe LTd.

Investigators

  • Principal Investigator: David Scott, MD, FRCP, Kings College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

February 22, 2006

First Submitted That Met QC Criteria

February 22, 2006

First Posted (ESTIMATE)

February 24, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

March 13, 2009

Last Update Submitted That Met QC Criteria

March 12, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D2450174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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