Clinical trial NCT00296257: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Dainippon Sumitomo Pharma Europe LTd.
Sponsor class: INDUSTRY
First posted: 2006-02-24
Enrollment: 312
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
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 outcomes:
measure: To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
measure: 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
Other outcomes:
Locations:
city: Ceska Lipa
country: Czech Republic
city: Ceske Budejovice
country: Czech Republic
city: Hlucin
country: Czech Republic
city: Ostrava Trebovice
country: Czech Republic
city: Prague 2
country: Czech Republic
city: Praha 5
country: Czech Republic
city: Terezin
country: Czech Republic
city: Uherske Hradiste
country: Czech Republic
city: Zlin
country: Czech Republic
city: Bad Nauheim
country: Germany
city: Freiburg
country: Germany
city: Hildesheim
country: Germany
city: Leipzig
country: Germany
city: Ratingen
country: Germany
city: Zerbst
country: Germany
city: Bekescsaba
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Debrecen
country: Hungary
city: Debrecen
country: Hungary
city: Esztergom
country: Hungary
city: Kecskemet
country: Hungary
city: Komarom
country: Hungary
city: Miskolc
country: Hungary
city: Szombathely
country: Hungary
city: Groningen
country: Netherlands
city: JD Alkmaar
country: Netherlands
city: Rotterdam
country: Netherlands
city: Czestochowa
country: Poland
city: Elbląg
country: Poland
city: Katowice
country: Poland
city: Lublin
country: Poland
city: Sopot
country: Poland
city: Swietokrzyce
country: Poland
city: Szczecin
country: Poland
city: Warsaw
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Birmingham
country: United Kingdom
city: Colchester
country: United Kingdom
city: Greenock
country: United Kingdom
city: Huddersfield
country: United Kingdom
city: London
country: United Kingdom
city: Maidstone
country: United Kingdom
city: Middlesborough
country: United Kingdom
city: Newcastle upon Tyne and Wear
country: United Kingdom
city: Wirral
country: United Kingdom
Study officials:
affiliation: Kings College Hospital
name: David Scott, MD, FRCP
role: PRINCIPAL_INVESTIGATOR
References: