ToFAcitinib in Early Active Axial SpondyloarThritis: (FASTLANE)

Charité University Medicine Berlin

Status and phase: Enrolling; Phase 4

Conditions: Axial Spondyloarthritis

Treatments: Drug: Tofacitinib 5 MG

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06112665

FASTLANE1

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Tofactinib

Experimental group

Description:

Patients receive Tofacitinib and Naproxene

Treatment:

Drug: Tofacitinib 5 MG

Placebo Arm

Active Comparator group

Description:

Patients receive placebo pills and Naproxene

Treatment:

Drug: Tofacitinib 5 MG