A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis

Trial Profile

A Phase Ib Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation, Safety and Tolerability Study of PRTX-100 in Combination With Methotrexate or Leflunomide in Patients With Active Rheumatoid Arthritis

Completed
Phase of Trial: Phase I

Latest Information Update: 16 Apr 2015

At a glance

  • Drugs Staphylococcal-protein-A (Primary)
  • Indications Rheumatoid arthritis
  • Focus Adverse reactions
  • Acronyms SPARTA
  • Sponsors Protalex
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 16 Apr 2015 Following an exploratory biomarker analysis of data from this study, Protalex intends to re-examine biomarkers from the PRTX-103 trial and perform combined analysis of the 103 Study and 104 Study biomarkers, to determine any next steps to explore the utility of the biomarker in identifying RA patients most likely to benefit from treatment with PRTX-100, according to a media release.
    • 16 Apr 2015 Results of final cohort published in Protalex media release.
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