ToFAcitinib in Early Active Axial SpondyloarThritis:

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Axial Spondyloarthritis

In brief

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.

Key facts

Study ID

NCT06112665

Run by

Charite University, Berlin, Germany

People needed

104

Starts

2023-11-10

Expected to finish

2026-06-01

Last updated by the study team

2024-11-26

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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