ToFAcitinib in Early Active Axial SpondyloarThritis:

NCT06112665 | Recruiting Phase 4

• 1 other identifier: FASTLANE1
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Axial Spondyloarthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  16 weeks

Study Arms (2)

Tofactinib

EXPERIMENTAL

Patients receive Tofacitinib and Naproxene

Drug: Tofacitinib 5 MG

Placebo Arm

ACTIVE COMPARATOR

Patients receive placebo pills and Naproxene

Drug: Tofacitinib 5 MG

Interventions

Tofacitinib 5 MG DRUG

Patients receive Tofacitinib and Naproxene

Placebo Arm; Tofactinib

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Pfizer: collaborator

Study Sites (1)

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

Related Publications (1)

• Rios Rodriguez V, Sanchez-Riera L, Haibel H, Hoppner C, Torgutalp M, Proft F, Rademacher J, Binder E, Diehl A, Vranic I, Zhao Y, Mundayat R, Yndestad A, Poddubnyy D. Tofacitinib in early active axial spondyloarthritis: protocol of a randomized double-blind, placebo-controlled, multicenter phase IV study, FASTLANE. Ther Adv Musculoskelet Dis. 2025 Mar 12;17:1759720X251324429. doi: 10.1177/1759720X251324429. eCollection 2025.

  PMID: 40078463 DERIVED

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

tofacitinib

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Officials

• Denis Poddubbnyy, Prof. Dr. med.

  Charité Rheumatology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hildrun Haibel, PD Dr. med.

CONTACT

+49308445; hildrun.haibel@charite.de

Valeria Rios-Rodriguez, Dr. med.

CONTACT

+30450; valeria.rios-rodriguez@charite.de

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: multicentre, randomized, double-blind, placebo-controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: 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 Record Dates

• First Submitted: October 29, 2023
• First Posted: November 1, 2023
• Study Start: November 10, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 6 months after study enrollment end
• Access Criteria: not known yet

Locations

DE (1)