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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Tofacitinib

Criteria

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