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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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