Evaluating tofacitinib for early active axial spondyloarthritis
ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
This study is testing if a medication called tofacitinib can help people with early active axial spondyloarthritis who haven't found relief from traditional pain relievers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Drugs / interventions | tofacitinib |
| Locations | 1 site (Berlin) |
| Trial ID | NCT06112665 on ClinicalTrials.gov |
What this trial studies
This phase IV, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of tofacitinib compared to a placebo in patients with early active axial spondyloarthritis (axSpA) who have not adequately responded to at least one NSAID. Participants will receive either tofacitinib or a placebo for 16 weeks, followed by a 4-week safety follow-up. The study focuses on individuals with objective signs of inflammation and significant disease activity, as measured by specific clinical criteria. The goal is to determine if tofacitinib can provide better outcomes than standard NSAID treatment.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with early active axial spondyloarthritis, experiencing significant symptoms for less than two years and showing objective signs of inflammation.
Not a fit: Patients with active infections, severe immunodeficiencies, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for patients with early active axial spondyloarthritis who do not respond well to NSAIDs.
How similar studies have performed: Previous studies have shown promising results with tofacitinib in other inflammatory conditions, suggesting potential success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Berlin
- Charité Universitätsmedizin Berlin — Berlin, Germany (Recruiting)
Study contacts
- Principal investigator: Denis Poddubbnyy, Prof. Dr. med. — Charité Rheumatology
- Study coordinator: Hildrun Haibel, PD Dr. med.
- Email: hildrun.haibel@charite.de
- Phone: +49308445
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.