ToFAcitinib in Early Active Axial SpondyloarThritis:

Axial Spondyloarthritis Clinical Trial

— FASTLANE  

Official title:

ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06112665
• Other study ID #: FASTLANE1
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 10, 2023
• Est. completion date: February 28, 2026

Study information

• Verified date: October 2023
• Source: Charite University, Berlin, Germany
• Contact: Hildrun Haibel, PD Dr. med.
• Phone: +49308445
• Email: hildrun.haibel[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: February 28, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis

Intervention

Drug:
• Tofacitinib 5 MG
Patients receive Tofacitinib and Naproxene

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main trial endpoint	Proportion of subjects achieving disease remission defined as Ankylosing Spondylitis Disease Activity Score (ASDAS)CRP<1.3 at week 16 from baseline	16 weeks
Secondary	Change from baseline in the MRI SIJ SPARCC osteitis score at week 16	Change from baseline in the MRI SIJ SPARCC osteitis score at week 16	16 weeks