Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement
NCT ID: NCT04062695
Last Updated: 2022-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2020-08-04
2023-12-31
Brief Summary
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Detailed Description
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Eligible patients (n=80) will be randomized 1:1 to receive either Tofacitinib 5mg orally twice daily or placebo for a 12-week period. After week 12, all patients will receive Tofacitinib 5mg orally twice daily for another 12 weeks. The study duration will include a 6-week screening period, a 24-week treatment period and a safety follow-up period of 4 weeks. Patients will be closely monitored throughout the study on a total of 11 visits. Safety data will be collected in the form of adverse events, vital parameters, physical examinations, and laboratory parameters throughout the study.
The baseline MRI of the whole spine and sacroiliac (SI) joints will be performed within the 6-week screening period to confirm the presence of active inflammation (bone marrow edema) compatible with Spondyloarthritis (will be assessed by a central reader), at week 12 to evaluate the primary study endpoint, and at week 24 to evaluate the secondary endpoint.
The primary study endpoint will be an improvement of the total Berlin MRI score for sacroiliac joints and spine at week 12 as compared to baseline.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Tofacitinib
5 mg oral BID
Tofacitinib 5 MG Oral Tablet [Xeljanz]
verum tablets
Placebo
matching Placebo BID
Placebo oral tablet
tablets containing placebo
Interventions
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Tofacitinib 5 MG Oral Tablet [Xeljanz]
verum tablets
Placebo oral tablet
tablets containing placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion 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 Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Charite University, Berlin, Germany
OTHER
Responsible Party
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Denis Poddubnyy
Prof. Dr. Denis Poddubnyy
Principal Investigators
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Denis Poddubnyy, Prof
Role: PRINCIPAL_INVESTIGATOR
Charite University, Dept. Rheumatology CBF
Locations
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Charite University, Rheumatology CCM
Berlin, , Germany
Praxis für Rheumatologie
Berlin, , Germany
Charite University - Dept. Rheumatology CBF
Berlin, , Germany
University Cologne, Dept. Rheumatology
Cologne, , Germany
Uniklinik, Forschungszentrum Rheumatologie
Düsseldorf, , Germany
Praxis Dilltal
Ehringshausen, , Germany
Uniklinikum, Med. Klinik 3
Erlangen, , Germany
CIRI Zentrum f innovative Diagnsotik und Therapie
Frankfurt am Main, , Germany
Uniklinikum, Dept. Rheumatologie
Freiburg im Breisgau, , Germany
Hamburger Rheumaforschungszentrum
Hamburg, , Germany
Rheumazentrum Ruhrgebiet
Herne, , Germany
Uniklinik, Rheumatologie
Kiel, , Germany
Klinikum Ludwigshafen, Rheumatologie
Ludwigshafen, , Germany
Rheumapraxis Dr. Sieburg
Magdeburg, , Germany
Inst. f Präventive Medizin & Klinische Forschung
Magdeburg, , Germany
Uniklinikum, I. Med. Klinik
Mainz, , Germany
Praxis Prof. Kellner
München, , Germany
Rheumatol Schwerpunktpraxis
Steglitz, , Germany
KH St. Josef, Dept. Rheumatology
Wuppertal, , Germany
Countries
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Central Contacts
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Facility Contacts
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Sandra Hermann, Dr
Role: primary
Kirsten Karberg, Dr
Role: primary
Deni Poddubnyy, Prof
Role: primary
David Kofler, PD
Role: primary
Philipp Severin, Dr
Role: primary
Mirko Steinmüller, Dr
Role: primary
Andreas Ramming, Dr
Role: primary
Frank Behrens, Dr
Role: primary
Stephanie Finzel, Dr
Role: primary
Hauke Heintz, Dr
Role: primary
Uta Kiltz, PD
Role: primary
Bimba Hoyer, Prof
Role: primary
Raoul Bergner, Prof
Role: primary
Maren Sieburg, Dr
Role: primary
Rüdiger Möricke, Prof
Role: primary
Andreas Schwarting, Prof
Role: primary
Herbert Kellner, Prof
Role: primary
Jan Brandt-Jürgens, PD Dr
Role: primary
Astrid Thiele, Dr
Role: primary
References
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Proft F, Torgutalp M, Muche B, Rios Rodriguez V, Verba M, Poddubnyy D. Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial. BMJ Open. 2021 Nov 16;11(11):e048647. doi: 10.1136/bmjopen-2021-048647.
Other Identifiers
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PASTOR2018
Identifier Type: -
Identifier Source: org_study_id
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