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

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Sumitomo Pharma

Status and phase

Terminated
Phase 2

Conditions

Rheumatoid Arthritis (RA)

Treatments

Drug: SMP-114

Study type

Interventional

Funder types

Industry

Identifiers

NCT00296257
D2450174

Details and patient eligibility

About

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.

Enrollment

312 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

47

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Data sourced from clinicaltrials.gov

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