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New treatment option for Axial Spondyloarthritis
Official title ToFAcitinib in Early Active Axial SpondyloarThritis:
ClinicalTrials.gov ID: NCT06112665
What this study is testing
What is Tofacitinib 5 MG?
Tofacitinib 5 MG is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for axial spondyloarthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- Time commitment: about 16 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join 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...
You likely can't join 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 16 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.