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ToFAcitinib in Early Active Axial SpondyloarThritis:

RecruitingPhase 4Ages 18 Years - 45 YearsAllCharite University, Berlin, Germany
NCT06112665 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 early axial SpA by ASAS. * Active disease activity as defined by: BASDAI ≥4 and back pain score (BASDAI question 2) of ≥4 AND objective signs of inflammation evident by osteitis in MRI of SIJ AND/OR elevated serum CRP levels. 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
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What it tests

  • Tofacitinib 5 MG
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Where

1 site
Charité Universitätsmedizin Berlin
Berlin, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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