Tests tofacitinib against placebo in early active axial spondyloarthritis
Tests tofacitinib against placebo in adults with early active spine inflammation.
Plain-language title generated from the registry record
Registry title: ToFAcitinib in Early Active Axial SpondyloarThritis:
Key facts
- Where
- Berlin, GermanySee the site
- Phase
- Phase 4
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06112665, who can take part
Where in Germany
- Charité Universitätsmedizin BerlinBerlin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Charite University, Berlin, Germany
- Trial code
- NCT06112665
- Record updated
- 26 November 2024
- Original description
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.Read full original descriptionShow less
ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
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.
Inclusion: 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: active current infection, severe infections in the last 3 months; history of recurrent Herpes zoster or disseminated Herpes simplex; chronic Hepatitis B, C or HIV infection; other severe diseases conflicting with a clinical study, contraindications for MRI; immunodeficiency; women: pregnant or lactating (have to practice reliable method of contraception).