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Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis

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Trial Profile

Phase II, Double-blind, Placebo-Controlled, Randomized Trial Examining Natrunix in Combination With Methotrexate (+Folate) for the Treatment of Rheumatoid Arthritis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 01 Apr 2025

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At a glance

  • Drugs Vilamakitug (Primary) ; Folic acid; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Sponsors XBiotech

Most Recent Events

  • 23 Dec 2024 According to an XBiotech media release, there were irregularities nvolved the highest enrolling clinical sites, including numerous subjects being enrolled multiple times. Although the study did not meet efficacy endpoints, discrepancies found during data analysis suggest caution in interpreting results. Findings of the study are still being analysed.
  • 23 Dec 2024 Primary endpoint has not been met. (ACR 20 response rate at 12 weeks.), According to an XBiotech media release.
  • 23 Dec 2024 Status changed from recruiting to completed, according to an XBiotech media release.

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