Rheumatoid Arthritis (RA)Phase 2NCT00296257
Assessment of Safety, Pharmacokinetics and Efficacy in a Combination Treatment With SMP-114
A Phase 2 study testing SMP-114 in people with Rheumatoid Arthritis (RA), run by Dainippon Sumitomo Pharma Europe LTd. at 46 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- SMP-114
- How many people
- 312 participants
- Where
- 46 sitesin 6 countries
- Study dates
- Feb 2006to Apr 2008
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 6 countries.
46 sites in 6 countries
Hungary10 sites
Study site
Békéscsaba, H5600
Study site
Budapest, H 1023
Study site
Budapest, H1023
Study site
Debrecen, H 4004
Study site
Debrecen, H 4043
Study site
Esztergom, H2500
Study site
Kecskemét, H6000
Study site
Komárom
Study site
Miskolc, H 3529
Study site
Szombathely, H 9700
Czechia9 sites
Study site
Česká Lípa, 470 01
Study site
České Budějovice, 370 00
Study site
Hlučín, 748 01
Study site
Ostrava Trebovice, 722 00
Study site
Prague, 128 50
Study site
Prague, 158 00
Study site
Terezín, 411 55
Study site
Uherské Hradiště, 686 01
Study site
Zlín, 760 01
Poland9 sites
Study site
Częstochowa
Study site
Elblag, 82-300
Study site
Katowice, 40-635
Study site
Lublin, 20-022
Study site
Sopot, 81-759
Study site
Swietokrzyce, 26-200
Study site
Szczecin, 71-252
Study site
Warsaw, 00-909
Study site
Warsaw, 02-637
United Kingdom9 sites
Study site
Birmingham, B29 6JD
Study site
Colchester, CO4 5JL
Study site
Greenock, PA16 0XN
Study site
Huddersfield, HD3 3EA
Study site
London, SE5 9PJ
Study site
Maidstone, ME16 9QQ
Study site
Metropolitan Borough of Wirral, CH49 5PE
Study site
Middlesbrough, TS4 3BW
Study site
Newcastle Upon Tyne and Wear, NE7 7DN
Germany6 sites
Study site
Bad Nauheim, 61231
Study site
Freiburg im Breisgau, 79106
Study site
Hildesheim, 31134
Study site
Leipzig, 04103
Study site
Ratingen, 40882
Study site
Zerbst, 3923
Netherlands3 sites
Study site
Groningen, 9713
Study site
JD Alkmaar, 1815
Study site
Rotterdam, 3078
About this study
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.
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.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- SMP-114
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMP-114Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startFeb 2006
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dainippon Sumitomo Pharma Europe LTd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- David Scott, MD, FRCP, Principal investigator, Kings College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00296257
- Sponsor's protocol ID
- D2450174
- Status last verified
- Mar 2009
- First submitted
- 22 Feb 2006
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes