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Recruiting

NCT Number: NCT06112665

ToFAcitinib in Early Active Axial SpondyloarThritis:

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.

Recruiting

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Key information

Conditions

Axial Spondyloarthritis Ankylosis Arthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Charité Universitätsmedizin Berlin

Berlin, Germany

Location status: Recruiting

Location contact

Dr. Valeria Rios Rodriguez

CONTACT

[email protected]

004930450514582

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tofacitinib 5 MG

Drug

Patients receive Tofacitinib and Naproxene

Primary outcomes

  1. Main trial endpoint

    Time frame: 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 outcomes

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

    Time frame: 16 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Hildrun Haibel, PD Dr. med.

CONTACT

[email protected]

+49308445 ext. 4414

Valeria Rios-Rodriguez, Dr. med.

CONTACT

[email protected]

+30450 ext. 543640

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Acronym: FASTLANE

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Nov 1, 2023
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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