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A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)

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Trial Profile

A 24-week phase IIb, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of tregalizumab (BT061) in combination with methotrexate in the treatment of subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate alone, followed by a 24-week extension phase:T cell REgulating Arthritis Trial 2b (TREAT 2b)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Tregalizumab (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Acronyms TREAT-2b
  • Sponsors Biotest AG

Most Recent Events

  • 17 Jan 2018 Results published in the Annals of the Rheumatic Diseases
  • 11 Jan 2016 Status changed from active, no longer recruiting to discontinued as reported by ClinicalTrials.gov record.
  • 11 Aug 2015 According to a Biotest AG media release, following a detailed analysis of the data from this phase IIb "Treat 2bStudy" of tregalizumab (BT-061) for rheumatoid arthritis, BT-061 showed a dose-dependent effect on cells in the immune system which did not translate into clinical efficacy. As a result, Biotest will discontinue the clinical development of tregalizumab (BT-061).

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