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

Sponsor
Charite University, Berlin, Germany
Study ID
NCT04062695
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Aug 4, 2020
Status verified
Jul 2022
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Tofacitinib
    5 mg oral BID
  • Placebo Comparator: Placebo
    matching Placebo BID

Primary Outcome Measure

MRI Berlin Score [ Time Frame: Week 12 vs Baseline ]

Central Contacts

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