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

Charité University Medicine Berlin

Status and phase: Enrolling; Phase 2

Conditions: Spondylitis; Psoriatic Arthritis; Sacroilitis

Treatments: Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz]; Drug: Placebo oral tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT04062695

PASTOR2018

Details and patient eligibility

About

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).

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Tofacitinib

Active Comparator group

Description:

5 mg oral BID

Treatment:

Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz]

Placebo

Placebo Comparator group

Description:

matching Placebo BID

Treatment:

Drug: Placebo oral tablet