Status:
UNKNOWN
Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Psoriatic Arthritis
Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and spine on magnetic resonance imaging (MRI) in patients with active Psoriatic Arthritis (PsA) with axial Inv...
Detailed Description
This study is a prospective, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy of Tofacitinib in reducing inflammation in the sacroiliac joints and in the spi...
Eligibility Criteria
Inclusion
- Psoriatic Arthritis fulfilling ClASsification for Psoriatic ARthritis (CASPAR) criteria
- chronic back pain \> 3 months
- BASDAI value ≥ 4 and backpain ≥ 4 / 10 VAS
- presence of active inflammation in Screening MRI of sacroiliac joints and / or spine (central reading)
- history of inadequate response to ≥ 2 NSAIDs or intolerance / contraindications
Exclusion
- 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
Key Trial Info
Start Date :
August 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04062695
Start Date
August 4 2020
End Date
December 1 2023
Last Update
July 26 2022
Active Locations (19)
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1
Charite University, Rheumatology CCM
Berlin, Germany, 10117
2
Praxis für Rheumatologie
Berlin, Germany, 12163
3
Charite University - Dept. Rheumatology CBF
Berlin, Germany, 12203
4
University Cologne, Dept. Rheumatology
Cologne, Germany, 50937