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Completed

NCT Number: NCT03757364

Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in 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.

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Key information

Conditions

Age range

34 year–57 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Warmia and Mazury

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

methotrexate

Drug

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

Other names: Methotrexate Ebeve, Metex,

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ryszard Górecki

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 28, 2018
Registry last updated
Nov 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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