Evaluating tofacitinib for early active axial spondyloarthritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IV, multicenter, randomized, double-blind, placebo-controlled study aims to assess the efficacy and safety of tofacitinib compared to a placebo in patients with early active axial spondyloarthritis (axSpA) who have not adequately responded to at least one NSAID. Participants will receive either tofacitinib or a placebo for 16 weeks, followed by a 4-week safety follow-up. The study focuses on individuals with objective signs of inflammation and significant disease activity, as measured by specific clinical criteria. The goal is to determine if tofacitinib can provide better outcomes than standard NSAID treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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

Where it's running

• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Denis Poddubbnyy, Prof. Dr. med. — Charité Rheumatology
• Study coordinator: Hildrun Haibel, PD Dr. med.
• Email: hildrun.haibel@charite.de
• Phone: +49308445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.