search
Back to results

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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SMP-114
Sponsored by
Dainippon Sumitomo Pharma Europe LTd.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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

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

Full Information

First Posted
February 22, 2006
Last Updated
March 12, 2009
Sponsor
Dainippon Sumitomo Pharma Europe LTd.
search

1. Study Identification

Unique Protocol Identification Number
NCT00296257
Brief Title
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
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 Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Terminated
Study Start Date
February 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Dainippon Sumitomo Pharma Europe LTd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
312 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SMP-114
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Scott, MD, FRCP
Organizational Affiliation
Kings College Hospital
Official's Role
Principal Investigator
Facility Information:
City
Ceska Lipa
ZIP/Postal Code
470 01
Country
Czech Republic
City
Ceske Budejovice
ZIP/Postal Code
370 00
Country
Czech Republic
City
Hlucin
ZIP/Postal Code
748 01
Country
Czech Republic
City
Ostrava Trebovice
ZIP/Postal Code
722 00
Country
Czech Republic
City
Prague 2
ZIP/Postal Code
128 50
Country
Czech Republic
City
Praha 5
ZIP/Postal Code
158 00
Country
Czech Republic
City
Terezin
ZIP/Postal Code
411 55
Country
Czech Republic
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czech Republic
City
Zlin
ZIP/Postal Code
760 01
Country
Czech Republic
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Hildesheim
ZIP/Postal Code
31134
Country
Germany
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
City
Ratingen
ZIP/Postal Code
40882
Country
Germany
City
Zerbst
ZIP/Postal Code
3923
Country
Germany
City
Bekescsaba
ZIP/Postal Code
H5600
Country
Hungary
City
Budapest
ZIP/Postal Code
H 1023
Country
Hungary
City
Budapest
ZIP/Postal Code
H1023
Country
Hungary
City
Debrecen
ZIP/Postal Code
H 4004
Country
Hungary
City
Debrecen
ZIP/Postal Code
H 4043
Country
Hungary
City
Esztergom
ZIP/Postal Code
H2500
Country
Hungary
City
Kecskemet
ZIP/Postal Code
H6000
Country
Hungary
City
Komarom
Country
Hungary
City
Miskolc
ZIP/Postal Code
H 3529
Country
Hungary
City
Szombathely
ZIP/Postal Code
H 9700
Country
Hungary
City
Groningen
ZIP/Postal Code
9713
Country
Netherlands
City
JD Alkmaar
ZIP/Postal Code
1815
Country
Netherlands
City
Rotterdam
ZIP/Postal Code
3078
Country
Netherlands
City
Czestochowa
Country
Poland
City
Elbląg
ZIP/Postal Code
82-300
Country
Poland
City
Katowice
ZIP/Postal Code
40-635
Country
Poland
City
Lublin
ZIP/Postal Code
20-022
Country
Poland
City
Sopot
ZIP/Postal Code
81-759
Country
Poland
City
Swietokrzyce
ZIP/Postal Code
26-200
Country
Poland
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
City
Warsaw
ZIP/Postal Code
02-637
Country
Poland
City
Warszawa
ZIP/Postal Code
00-909
Country
Poland
City
Warszawa
ZIP/Postal Code
02-637
Country
Poland
City
Birmingham
ZIP/Postal Code
B29 6JD
Country
United Kingdom
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
City
Greenock
ZIP/Postal Code
PA16 0XN
Country
United Kingdom
City
Huddersfield
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
City
London
ZIP/Postal Code
SE5 9PJ
Country
United Kingdom
City
Maidstone
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
City
Middlesborough
ZIP/Postal Code
TS4 3BW
Country
United Kingdom
City
Newcastle upon Tyne and Wear
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
City
Wirral
ZIP/Postal Code
CH49 5PE
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs