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FASTLANE: ToFAcitinib in Early Active Axial SpondyloarThritis:

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06112665
Collaborator
Pfizer (Industry)
104
Enrollment
2
Arms
27.6
Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tofacitinib 5 MG
 Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model 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 inflammationThis 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
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
multicentre, randomized, double-blind, placebo-controlled study
Primary Purpose:
Treatment
Official Title:
ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
Anticipated Study Start Date :
Nov 10, 2023
Anticipated Primary Completion Date :
Nov 30, 2025
Anticipated Study Completion Date :
Feb 28, 2026

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Main trial endpoint [16 weeks]

    Proportion of subjects achieving disease remission defined as Ankylosing Spondylitis Disease Activity Score (ASDAS)CRP<1.3 at week 16 from baseline

Secondary Outcome Measures

  1. Change from baseline in the MRI SIJ SPARCC osteitis score at week 16 [16 weeks]

    Change from baseline in the MRI SIJ SPARCC osteitis score at week 16

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Charite University, Berlin, Germany
  • Pfizer

Investigators

  • Principal Investigator: Denis Poddubbnyy, Prof. Dr. med., Charité Rheumatology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denis Poddubnyy, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT06112665
Other Study ID Numbers:
  • FASTLANE1
First Posted:
Nov 1, 2023
Last Update Posted:
Nov 1, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Spondylitis
Spondylarthritis
Axial Spondyloarthritis
Tofacitinib

Study Results

No Results Posted as of Nov 1, 2023