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APPRAIS - A 24-week multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate

Trial Profile

APPRAIS - A 24-week multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy, safety and tolerability of orally administered Rabeximod in patients with active, moderate to severe rheumatoid arthritis with inadequate response to methotrexate

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 13 Sep 2023

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At a glance

  • Drugs Rabeximod (Primary)
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Acronyms APPRAIS
  • Sponsors Cyxone
  • Most Recent Events

    • 23 Jun 2022 According to a Cyxone media release, the company has filed a submission to the National Institute of Pharmacy and Nutrition (OGYEI) - the Hungarian Medical Product Agency - for approval to start the trial. This will be followed by applications to relevant regulatory authorities in other European countries.
    • 29 Jan 2020 According to a Cyxone media release, once the permission is approved. The patient recruitment can commence in the selected countries.
    • 29 Jan 2020 According to a Cyxone media release, this study is in parallel in the process of securing permission to conduct this study in select countries. To date, approvals from Ethics Committees have been obtained in two countries with the additional applications still in process. After the Ethics Committee approval, additional documentation will be submitted to the final regulatory approval with each country's competent authority.
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