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

NCT00296257 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2009-03-13

No results posted yet for this study

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.

Conditions

  • Rheumatoid Arthritis (RA)

Interventions

DRUG

SMP-114

Sponsors & Collaborators

  • Dainippon Sumitomo Pharma Europe LTd.

    lead INDUSTRY

Principal Investigators

  • David Scott, MD, FRCP · Kings College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-28
Completion
2008-04-30

Countries

  • Czechia
  • Germany
  • Hungary
  • Netherlands
  • Poland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00296257 on ClinicalTrials.gov