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

This study has been terminated.
Sponsor:
Information provided by:
Dainippon Sumitomo Pharma Europe LTd.
ClinicalTrials.gov Identifier:
NCT00296257
First received: February 22, 2006
Last updated: March 12, 2009
Last verified: March 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00296257

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

No publications provided

ClinicalTrials.gov 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
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
 Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013