ToFAcitinib in Early Active Axial SpondyloarThritis: (FASTLANE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Axial Spondyloarthritis
• Intervention / Treatment: Drug: Tofacitinib 5 MG

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Hildrun Haibel, PD Dr. med.; Phone Number: 4414 +49308445; Email: hildrun.haibel@charite.de
• Study Contact Backup: Name: Valeria Rios-Rodriguez, Dr. med.; Phone Number: 543640 +30450; Email: valeria.rios-rodriguez@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charité Universitätsmedizin Berlin
    • Contact: Dr. Valeria Rios Rodriguez; Phone Number: 004930450514582; Email: valeria.rios-rodriguez@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tofactinib; Patients receive Tofacitinib and Naproxene	Drug: Tofacitinib 5 MG; Patients receive Tofacitinib and Naproxene
Active Comparator: Placebo Arm; Patients receive placebo pills and Naproxene	Drug: Tofacitinib 5 MG; Patients receive Tofacitinib and Naproxene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Collaborators: Pfizer
• Investigators: Principal Investigator: Denis Poddubbnyy, Prof. Dr. med., Charité Rheumatology

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 29, 2023
• First Submitted That Met QC Criteria: October 29, 2023
• First Posted (Actual): November 1, 2023

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Infections; Bone Diseases, Infectious; Spinal Diseases; Spondylarthropathies; Ankylosis; Axial Spondyloarthritis; Spondylitis; Spondylarthritis; Janus Kinase Inhibitors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Tofacitinib
• Other Study ID Numbers: FASTLANE1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Undecided: It is not yet known if there will be a plan to make IPD available.
• IPD Sharing Time Frame: 6 months after study enrollment end
• IPD Sharing Access Criteria: not known yet
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No