NCT04062695

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2020

Typical duration for phase_2

Geographic Reach
1 country

19 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 14, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 20, 2019

Completed
12 months until next milestone

Study Start

First participant enrolled

August 4, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

3.3 years

First QC Date

May 14, 2019

Last Update Submit

July 23, 2022

Conditions

Psoriatic ArthritisSpondylitisSacroilitis

Keywords

Psoriatic ArthritisSacroiliitisSpondylitisMRI

Outcome Measures

Primary Outcomes (1)

  • MRI Berlin Score

    Improvement of the Berlin MRI score for sacroiliac joints and spine. Scoring includes spinal inflammation (Lucas C et al, J Rheumatol 2007): 23 vertebral units with semiquantitative range of inflammation between 0 to 3 (min. score = 0, max. score = 69, the higher the worse). Additionally, inflammation of the sacroiliac joints is scored (Hermann KG, Rheumatologe 2004; scoring each quadrant between 0 and 4, max. score 16, the higher, the worse).

    Week 12 vs Baseline

Secondary Outcomes (15)

  • The Assessment of Spondyloarthritis International Society (ASAS) response criteria

    Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12

  • Responses in ASAS Health Index

    Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12

  • Responses in ASDAS

    Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12

  • Responses in BASDAI

    Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12

  • Responses in BASFI

    Week 12 vs Baseline, Week 24 vs Baseline, Week 24 vs Week 12

  • +10 more secondary outcomes

Study Arms (2)

Tofacitinib

ACTIVE COMPARATOR

5 mg oral BID

Drug: Tofacitinib 5 MG Oral Tablet [Xeljanz]

Placebo

PLACEBO COMPARATOR

matching Placebo BID

Drug: Placebo oral tablet

Interventions

Tofacitinib 5 MG Oral Tablet [Xeljanz]DRUG

verum tablets

Also known as: Xeljanz
Tofacitinib
Placebo oral tabletDRUG

tablets containing placebo

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Charite University, Rheumatology CCM

Berlin, 10117, Germany

RECRUITING

Praxis für Rheumatologie

Berlin, 12163, Germany

RECRUITING

Charite University - Dept. Rheumatology CBF

Berlin, 12203, Germany

RECRUITING

University Cologne, Dept. Rheumatology

Cologne, 50937, Germany

RECRUITING

Uniklinik, Forschungszentrum Rheumatologie

Düsseldorf, 40225, Germany

RECRUITING

Praxis Dilltal

Ehringshausen, 35630, Germany

RECRUITING

Uniklinikum, Med. Klinik 3

Erlangen, 91054, Germany

RECRUITING

CIRI Zentrum f innovative Diagnsotik und Therapie

Frankfurt am Main, 60590, Germany

RECRUITING

Uniklinikum, Dept. Rheumatologie

Freiburg im Breisgau, 79106, Germany

RECRUITING

Hamburger Rheumaforschungszentrum

Hamburg, 22391, Germany

RECRUITING

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

RECRUITING

Uniklinik, Rheumatologie

Kiel, 24105, Germany

RECRUITING

Klinikum Ludwigshafen, Rheumatologie

Ludwigshafen, 67063, Germany

RECRUITING

Rheumapraxis Dr. Sieburg

Magdeburg, 39104, Germany

RECRUITING

Inst. f Präventive Medizin & Klinische Forschung

Magdeburg, 39110, Germany

RECRUITING

Uniklinikum, I. Med. Klinik

Mainz, 55131, Germany

RECRUITING

Praxis Prof. Kellner

München, 80935, Germany

RECRUITING

Rheumatol Schwerpunktpraxis

Steglitz, 12161, Germany

RECRUITING

KH St. Josef, Dept. Rheumatology

Wuppertal, 42105, Germany

RECRUITING

Related Publications (1)

  • Proft F, Torgutalp M, Muche B, Rios Rodriguez V, Verba M, Poddubnyy D. Efficacy of tofacitinib in reduction of inflammation detected on MRI in patients with Psoriatic ArthritiS presenTing with axial involvement (PASTOR): protocol of a randomised, double-blind, placebo-controlled, multicentre trial. BMJ Open. 2021 Nov 16;11(11):e048647. doi: 10.1136/bmjopen-2021-048647.

    PMID: 34785545DERIVED

MeSH Terms

Conditions

Arthritis, PsoriaticSpondylitisSacroiliitis

Interventions

tofacitinibTablets

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesPsoriasisSkin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesBone Diseases, InfectiousInfections

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Denis Poddubnyy, Prof

    Charite University, Dept. Rheumatology CBF

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabian N Proft, MD

CONTACT

+49-30-450fabian.proft@charite.de

Bianca Mandt, SN

CONTACT

+49-30-8445bianca.mandt@charite.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Placebo controlled parallel group for 12 weeks followed by 12 weeks open label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Denis Poddubnyy

Study Record Dates

First Submitted

May 14, 2019

First Posted

August 20, 2019

Study Start

August 4, 2020

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(19)