Status:
RECRUITING
ToFAcitinib in Early Active Axial SpondyloarThritis:
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Pfizer
Conditions:
Axial Spondyloarthritis
Eligibility:
All Genders
18-45 years
Phase:
PHASE4
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 week...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT06112665
Start Date
November 10 2023
End Date
June 1 2026
Last Update
November 26 2024
Active Locations (1)
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1
Charité Universitätsmedizin Berlin
Berlin, Germany