Clinical trial
ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
Name
FASTLANE1
Description
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.
Trial arms
Trial start
2023-11-10
Estimated PCD
2025-11-30
Trial end
2026-02-28
Status
Not yet recruiting
Phase
Early phase I
Treatment
Tofacitinib 5 MG
Patients receive Tofacitinib and Naproxene
Arms:
Placebo Arm, Tofactinib
Size
104
Primary endpoint
Main trial endpoint
16 weeks
Eligibility 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
Protocol
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Updated at
2023-11-01
1 organization
1 product
1 indication
Organization
Charite UniversityProduct
TofacitinibIndication
Axial Spondyloarthritis