NCT06112665 ToFAcitinib in Early Active Axial SpondyloarThritis:
| NCT ID | NCT06112665 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Charite University, Berlin, Germany |
| Condition | Axial Spondyloarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 104 participants |
| Start Date | 2023-11-10 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 104 participants in total. It began in 2023-11-10 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Denis Poddubbnyy, Prof. Dr. med.
PRINCIPAL INVESTIGATOR
Charité Rheumatology
Frequently Asked Questions
Who can join the NCT06112665 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Axial Spondyloarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06112665 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06112665 currently recruiting?
Yes, NCT06112665 is actively recruiting participants. Contact the research team at hildrun.haibel@charite.de for enrollment information.
Where is the NCT06112665 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT06112665 clinical trial?
NCT06112665 is sponsored by Charite University, Berlin, Germany. The principal investigator is Denis Poddubbnyy, Prof. Dr. med. at Charité Rheumatology. The trial plans to enroll 104 participants.