NCT03757364

Brief Summary

The primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 7, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
Last Updated

November 28, 2018

Status Verified

November 1, 2018

Enrollment Period

9 months

First QC Date

November 25, 2018

Last Update Submit

November 25, 2018

Conditions

Nail Psoriasis

Keywords

Distal Interphalangeal Joint Extensor Tendon EnthesopathyNail Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Effect of Methotrexate on Distal Interphalangeal Joint Extensor Tendon Enthesopathy

    Ultrasonographic assessment of the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis.

    6 months

Secondary Outcomes (1)

  • Effect of Methotrexate on Morphological Changes in Psoriatic Nails

    6 months

Study Arms (2)

19 patients with Ps

19 patients with Ps with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months

Drug: Methotrexate

13 patients with PsA

13 patients with PsA with psoriatic changes in nails treated at the Dermatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy who were started on methotrexate during the study and the treatment continued for 6 months

Drug: Methotrexate

Interventions

MethotrexateDRUG

Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis

Also known as: Methotrexate Ebeve, Metex,
13 patients with PsA19 patients with Ps

Eligibility Criteria

Age34 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with psoriatic changes in nails with distal interphalangeal extensor tendon enthesopathy in ultrasound examination

You may qualify if:

  • Patients with psoriatic changes in nails treated at the Rheumatological Clinic in Olsztyn and the Clinic of Dermatology, Sexually Transmitted Diseases and Clinical Immunology of the University of Warmia and Mazury in Olsztyn, in whom a US examination revealed DIP joint extensor tendon enthesopathy

You may not qualify if:

  • Patients diagnosed with osteoarthritis of hands, those who work hard physically and those with changes in nails other than caused by psoriasis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Warmia and Mazury

Olsztyn, Warmian-Masurian Voivodeship, 10-900, Poland

Location

Related Publications (2)

  • Krajewska-Wlodarczyk M, Owczarczyk-Saczonek A, Placek W, Wojtkiewicz M, Wiktorowicz A, Wojtkiewicz J. Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic Arthritis. Biomed Res Int. 2018 Sep 9;2018:8251097. doi: 10.1155/2018/8251097. eCollection 2018.

    PMID: 30271786BACKGROUND

  • McGonagle D, Tan AL, Benjamin M. The nail as a musculoskeletal appendage--implications for an improved understanding of the link between psoriasis and arthritis. Dermatology. 2009;218(2):97-102. doi: 10.1159/000182250. Epub 2008 Dec 6.

    PMID: 19060455BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood probes for laboratory test

MeSH Terms

Interventions

Methotrexate

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Magdalena Krajewska-Włodarczyk, PhD

    University of Warmia and Mazury

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Collegium Medicum, Clinical Professor

Study Record Dates

First Submitted

November 25, 2018

First Posted

November 28, 2018

Study Start

January 7, 2018

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 28, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)