Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis

November 25, 2018 updated by: Ryszard Górecki

Effect of Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Patients With Nail Psoriasis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Nail psoriasis is one of the risk factors for psoriatic arthritis (PsA), especially with distal interphalangeal joints affected. Nail changes in psoriasis have been observed in 10-55% of patients, and the nail psoriasis-related inflammation can spread to adjacent structures, including DIP joints and digital extensor tendons. Enthesopathies are among the characteristic features of psoriatic arthritis. In everyday practice, assessment of psoriatic changes in nails is based mainly on clinical indices, such as nail psoriasis severity index (NAPSI) and modified NAPSI (mNAPSI), while imaging examinations, such as ultrasonography are performed much less frequently.

The findings of this study may assess the reasonableness of systemic treatment of nail psoriasis in patients without arthritis as enthesopathy prevention as well as the usability of US nail examinations in Ps and PsA patients in assessment of morphological changes and a response to treatment.

A US examination of nails and distal interphalangeal joint extensor tendons are conducted in all of the patients twice at an interval of six months. The examination is conducted by a rheumatologist experienced in ultrasound examinations of the skeletal and muscular system. An assessment of the nails, extensor tendons and DIP joints is made by placing the head on the dorsal side. In order to avoid pressure on surface tissues, an appropriate amount of gel without gel pads was used. The intensified blood flow, made visible by the PD technique, is confirmed by pulsed wave Doppler spectrum. The nail thickness is measured as the maximum distance between the dorsal and ventral nail plates. The nail bed thickness is measured as the distance between the ventral plate and the bone margin of the distal phalanx. The nail matrix thickness is measured at the proximal end of the nail bed.

The study was approved by the Bioethics Committee of the Warmia and Mazury Chamber of Physicians The study are conducted according to the Good Clinical Practice guidelines. Each participant signs an informed consent and be coded with unique ID.

Results of analyses will be saved by indexing with ID code only, personal data with individual IDs will be saved in additional file. All hard copy will be archived in secure room with coded electronic key.

Study Type

Observational

Enrollment (Actual)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland, 10-900
        • University of Warmia and Mazury

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis
Other Names:
  • Methotrexate Ebeve, Metex,
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
Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis
Other Names:
  • Methotrexate Ebeve, Metex,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Methotrexate on Distal Interphalangeal Joint Extensor Tendon Enthesopathy
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Methotrexate on Morphological Changes in Psoriatic Nails
Time Frame: 6 months
Ultrasonographic assessment of the effect of methotrexate on morphological changes in psoriatic nails
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ryszard Górecki

Investigators

  • Principal Investigator: Magdalena Krajewska-Włodarczyk, PhD, University of Warmia and Mazury

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 7, 2018

Primary Completion (Actual)

September 30, 2018

Study Completion (Actual)

September 30, 2018

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 25, 2018

First Posted (Actual)

November 28, 2018

Study Record Updates

Last Update Posted (Actual)

November 28, 2018

Last Update Submitted That Met QC Criteria

November 25, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UWM/Ps-ENTH.2018/001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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