Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
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.
1 other identifier
interventional
312
6 countries
46
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2006
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 22, 2006
CompletedFirst Posted
Study publicly available on registry
February 24, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2008
CompletedMarch 13, 2009
March 1, 2009
February 22, 2006
March 12, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
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 (2)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Unknown Facility
Česká Lípa, 470 01, Czechia
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České Budějovice, 370 00, Czechia
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Hlučín, 748 01, Czechia
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Ostrava Trebovice, 722 00, Czechia
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Prague, 128 50, Czechia
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Prague, 158 00, Czechia
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Terezín, 411 55, Czechia
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Uherské Hradiště, 686 01, Czechia
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Zlín, 760 01, Czechia
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Bad Nauheim, 61231, Germany
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Freiburg im Breisgau, 79106, Germany
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Hildesheim, 31134, Germany
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Leipzig, 04103, Germany
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Ratingen, 40882, Germany
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Zerbst, 3923, Germany
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Békéscsaba, H5600, Hungary
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Budapest, H 1023, Hungary
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Budapest, H1023, Hungary
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Debrecen, H 4004, Hungary
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Debrecen, H 4043, Hungary
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Esztergom, H2500, Hungary
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Kecskemét, H6000, Hungary
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Komárom, Hungary
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Miskolc, H 3529, Hungary
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Szombathely, H 9700, Hungary
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Groningen, 9713, Netherlands
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JD Alkmaar, 1815, Netherlands
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Rotterdam, 3078, Netherlands
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Częstochowa, Poland
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Elblag, 82-300, Poland
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Katowice, 40-635, Poland
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Lublin, 20-022, Poland
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Sopot, 81-759, Poland
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Swietokrzyce, 26-200, Poland
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Szczecin, 71-252, Poland
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Warsaw, 00-909, Poland
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Warsaw, 02-637, Poland
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Birmingham, B29 6JD, United Kingdom
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Colchester, CO4 5JL, United Kingdom
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Greenock, PA16 0XN, United Kingdom
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Huddersfield, HD3 3EA, United Kingdom
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London, SE5 9PJ, United Kingdom
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Maidstone, ME16 9QQ, United Kingdom
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Metropolitan Borough of Wirral, CH49 5PE, United Kingdom
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Middlesbrough, TS4 3BW, United Kingdom
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Newcastle Upon Tyne and Wear, NE7 7DN, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Scott, MD, FRCP
Kings College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
February 22, 2006
First Posted
February 24, 2006
Study Start
February 1, 2006
Study Completion
April 1, 2008
Last Updated
March 13, 2009
Record last verified: 2009-03