ToFAcitinib in Early Active Axial SpondyloarThritis:

Last updated: November 22, 2024
Sponsor: Charite University, Berlin, Germany
Overall Status: Active - Recruiting

Phase

4

Condition

Ankylosing Spondylitis

Treatment

Tofacitinib 5 MG

Clinical Study ID

NCT06112665
FASTLANE1
  • Ages 18-45
  • All Genders

Study Summary

This is a phase IV, multicentre, randomized, double-blind, placebo-controlled study designed to compare the efficacy and safety of tofacitinib versus placebo (on a background of an NSAID) over 16 weeks of treatment and 4 weeks of safety follow-up in subjects with early active axSpA and inadequate response to at least one NSAID, with objective signs of inflammation.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinical diagnosis of axSpA and fulfilment of the ASAS classification criteria

  • Symptom (back pain) duration for ≤ 2 years, according to the definition of earlyaxial SpA by ASAS.

  • Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAIquestion 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI ofSIJ AND/OR elevated serum CRP levels.

Exclusion

Exclusion criteria:

  • active current infection, severe infections in the last 3 months

  • history of recurrent Herpes zoster or disseminated Herpes simplex

  • immunodeficiency

  • chronic Hepatitis B, C or HIV infection

  • women: pregnant or lactating (have to practice reliable method of contraception)

  • other severe diseases conflicting with a clinical study, contraindications for MRI

Study Design

Total Participants: 104
Treatment Group(s): 1
Primary Treatment: Tofacitinib 5 MG
Phase: 4
Study Start date:
November 10, 2023
Estimated Completion Date:
June 30, 2026

Connect with a study center

  • Charité Universitätsmedizin Berlin

    Berlin,
    Germany

    Active - Recruiting

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