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ToFAcitinib in Early Active Axial SpondyloarThritis:

RECRUITINGPhase 4Sponsored by Charite University, Berlin, Germany
Actively Recruiting
PhasePhase 4
SponsorCharite University, Berlin, Germany
Started2023-11-10
Est. completion2025-03
Eligibility
Age18 Years – 45 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT06112665

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

Age: 18 Years – 45 YearsHealthy volunteers accepted
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

Conditions2

ArthritisAxial Spondyloarthritis

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