Axial SpondyloarthritisPhase 4FASTLANENCT06112665
ToFAcitinib in Early Active Axial SpondyloarThritis:
A Phase 4 study testing Tofacitinib 5 MG in people with Axial Spondyloarthritis, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Tofacitinib 5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteGermany
- Study dates
- 10 Nov 2023to Jun 2026
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berlin
Berlin
Dr. Valeria Rios Rodriguez, 004930450514582, valeria.rios-rodriguez@charite.de
About this study
Official title: 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.
- Conditions
- Axial Spondyloarthritis
- Being tested
- Tofacitinib 5 MG
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tofacitinib 5 MGDrug
Patients receive Tofacitinib and Naproxene
| Study group | Role | What they receive |
|---|---|---|
| Tofactinib | Experimental | Patients receive Tofacitinib and Naproxene Receives: Drug: Tofacitinib 5 MG |
| Placebo Arm | Active comparator | Patients receive placebo pills and Naproxene Receives: Drug: Tofacitinib 5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (1)
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
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start10 Nov 2023
- Primary completionMar 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 inflammation
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, Denis Poddubnyy, Charite University, Berlin, Germany
- Investigators
- Denis Poddubbnyy, Prof. Dr. med., Principal investigator, Charité Rheumatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112665
- Sponsor's protocol ID
- FASTLANE1
- Acronym
- FASTLANE
- Status last verified
- Nov 2024
- First submitted
- 29 Oct 2023
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
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.
PubMed 40078463