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

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ClinicalTrials.gov Identifier: NCT03757364
Recruitment Status : Completed
First Posted : November 28, 2018
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Ryszard Górecki, University of Warmia and Mazury

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.

Condition or disease Intervention/treatment
Nail Psoriasis Drug: Methotrexate

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.


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Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Effect of Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Patients With Nail Psoriasis
Actual Study Start Date : January 7, 2018
Actual Primary Completion Date : September 30, 2018
Actual Study Completion Date : September 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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 Name: 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 Name: Methotrexate Ebeve, Metex,




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
blood probes for laboratory test


Information from the National Library of Medicine

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Ages Eligible for Study:   34 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with psoriatic changes in nails with distal interphalangeal extensor tendon enthesopathy in ultrasound examination
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03757364


Locations
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Poland
University of Warmia and Mazury
Olsztyn, Warminsko-mazurskie, Poland, 10-900
Sponsors and Collaborators
Ryszard Górecki
Investigators
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Principal Investigator: Magdalena Krajewska-Włodarczyk, PhD University of Warmia and Mazury

Additional Information:
Publications:
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Responsible Party: Ryszard Górecki, Head of Collegium Medicum, Clinical Professor, University of Warmia and Mazury
ClinicalTrials.gov Identifier: NCT03757364     History of Changes
Other Study ID Numbers: UWM/Ps-ENTH.2018/001
First Posted: November 28, 2018    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Ryszard Górecki, University of Warmia and Mazury:
Distal Interphalangeal Joint Extensor Tendon Enthesopathy
Nail Psoriasis
Additional relevant MeSH terms:
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Enthesopathy
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Tendon Injuries
Wounds and Injuries
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors