UnknownPhase 2

Tofacitinib for Reduction of Spinal Inflammation in Patients With Psoriatic ArthritiS PresenTing With Axial InvOlvement

Germany80 participantsStarted 2020-08-04

Plain-language 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 Involvement (BASDAI \[Bath Ankylosing Spondylitis Disease Activity Index\] ≥ 4 and total backpain ≥ 4 despite treatment with NSAIDs plus evidence of active inflammation in the sacroiliac joints or spine on MRI).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 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

What they're measuring

MRI Berlin Score

Timeframe: Week 12 vs Baseline

Trial details

NCT IDNCT04062695

SponsorCharite University, Berlin, Germany

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12

Contact for this trial

Fabian N Proft, MD

+49-30-450 fabian.proft@charite.de

View on ClinicalTrials.gov More Psoriatic Arthritis trials