Actively Recruiting
ToFAcitinib in Early Active Axial SpondyloarThritis:
Led by Charite University, Berlin, Germany · Updated on 2024-11-26
104
Participants Needed
1
Research Sites
133 weeks
Total Duration
On this page
Sponsors
C
Charite University, Berlin, Germany
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
ToFAcitinib in Early Active Axial SpondyloarThritis:
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of axial spondyloarthritis meeting ASAS classification criteria
- Back pain symptoms lasting 2 years or less
- Active disease with BASDAI score of 4 or higher and back pain score of 4 or higher
- Objective signs of inflammation shown by osteitis on MRI of sacroiliac joints and/or elevated CRP levels
You will not qualify if you...
- Active infection or severe infection within the past 3 months
- History of recurrent Herpes zoster or widespread Herpes simplex infections
- Immunodeficiency
- Chronic Hepatitis B, Hepatitis C, or HIV infection
- Women who are pregnant, breastfeeding, or not using reliable contraception
- Other severe illnesses that conflict with study participation or contraindicate MRI
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Charité Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
Research Team
H
Hildrun Haibel, PD Dr. med.
CONTACT
V
Valeria Rios-Rodriguez, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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