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

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ClinicalTrials.gov Identifier: NCT00296257
Recruitment Status : Terminated
First Posted : February 24, 2006
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis (RA) Drug: SMP-114 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 312 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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.
Study Start Date : February 2006
Study Completion Date : April 2008

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U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. To compare efficacy of SMP-114 versus placebo after 24 weeks in terms of ACR50, ACR70, DAS28 and EULAR response.
  2. 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

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00296257     History of Changes
Other Study ID Numbers: D2450174
First Posted: February 24, 2006    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents