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

This study has been terminated.
Information provided by:
Dainippon Sumitomo Pharma Europe LTd. Identifier:
First received: February 22, 2006
Last updated: March 12, 2009
Last verified: March 2009

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.

Condition Intervention Phase
Rheumatoid Arthritis (RA)
Drug: SMP-114
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Further study details as provided by Dainippon Sumitomo Pharma Europe LTd.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Enrollment: 312
Study Start Date: February 2006
Study Completion Date: April 2008

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00296257

  Show 47 Study Locations
Sponsors and Collaborators
Dainippon Sumitomo Pharma Europe LTd.
Principal Investigator: David Scott, MD, FRCP Kings College Hospital
  More Information

No publications provided Identifier: NCT00296257     History of Changes
Other Study ID Numbers: D2450174
Study First Received: February 22, 2006
Last Updated: March 12, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
Germany: Federal Institute for Drugs and Medical Devices
Poland: Urzad Rejestracji Produktow Leczniczych
Czech Republic: State Institute for Drug Control
Netherlands:Central Committee on Research Involving Human Subjects
Hungary: National Institute of Pharmacy

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions processed this record on April 17, 2014