ToFAcitinib in Early Active Axial SpondyloarThritis:

• Status: Not yet recruiting
• Trial end date: 2026-02-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Collaborator: Pfizer
• Treatments: Tofacitinib

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 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