- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06112665
ToFAcitinib in Early Active Axial SpondyloarThritis: (FASTLANE)
October 29, 2023 updated by: Denis Poddubnyy, Charite University, Berlin, Germany
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
104
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tofactinib
Patients receive Tofacitinib and Naproxene
|
Patients receive Tofacitinib and Naproxene
|
Active Comparator: Placebo Arm
Patients receive placebo pills and Naproxene
|
Patients receive Tofacitinib and Naproxene
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Denis Poddubbnyy, Prof. Dr. med., Charité Rheumatology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
November 10, 2023
Primary Completion (Estimated)
November 30, 2025
Study Completion (Estimated)
February 28, 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 (Actual)
November 1, 2023
Last Update Submitted That Met QC Criteria
October 29, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Joint Diseases
- Musculoskeletal Diseases
- Arthritis
- Spinal Diseases
- Bone Diseases
- Spondylarthropathies
- Bone Diseases, Infectious
- Ankylosis
- Spondylitis
- Spondylarthritis
- Axial Spondyloarthritis
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Janus 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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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