ToFAcitinib in Early Active Axial SpondyloarThritis: a Prospective, Randomized, Double-BLind, PlAcebo-CoNtrolled MulticEntre Study
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Contact Information
Primary
Hildrun Haibel, PD Dr. med.
hildrun.haibel@charite.de
+49308445
Backup
Valeria Rios-Rodriguez, Dr. med.
valeria.rios-rodriguez@charite.de
+30450
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2026-06
Participants
Target number of participants: 104
Treatments
Experimental: Tofactinib
Patients receive Tofacitinib and Naproxene
Active_comparator: Placebo Arm
Patients receive placebo pills and Naproxene
Related Therapeutic Areas
Sponsors
Collaborators: Pfizer
Leads: Charite University, Berlin, Germany