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

  • STATUS
    Recruiting
  • End date
    Jun 5, 2022
  • participants needed
    80
  • sponsor
    Charite University, Berlin, Germany
Updated on 5 February 2021
Investigator
Fabian N Proft, MD
Primary Contact
Uniklinikum, Med. Klinik 3 (8.7 mi away) Contact
+18 other location
tofacitinib
steroidal anti-inflammatory drugs
NSAID
arthritis
spondylitis
ankylosing spondylitis

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).

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 spine on MRI in patients with active axial PsA.

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.

Details
Condition Spondylitis, Psoriasis, PSORIATIC ARTHRITIS, Arthritis, Arthritis and Arthritic Pain, Psoriasis and Psoriatic Disorders, Arthritis and Arthritic Pain (Pediatric), Sacroilitis
Treatment Placebo Oral Tablet, Tofacitinib 5 MG Oral Tablet [Xeljanz]
Clinical Study IdentifierNCT04062695
SponsorCharite University, Berlin, Germany
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

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
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