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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00296257

Enrollment

312

Registered

2006-02-24

Start date

2006-02-28

Completion date

2008-04-30

Last updated

2009-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA)

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.

Interventions

DRUGSMP-114

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Czechia, Germany, Hungary, Netherlands, Poland, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026