ToFAcitinib in Early Active Axial SpondyloarThritis:
Recruiting
Phase 4
Interventional Study
Axial Spondyloarthritis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 45
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 104 (estimated)
- Sponsor
- Charite University, Berlin, Germany · Other
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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…
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