Nail PsoriasisNCT03757364
Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Nail Psoriasis
An observational study of Nail Psoriasis, run by Ryszard Górecki at 1 site in Poland.
Trial summary
The primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy. Read more about this study
- Who is it for?
- Ages 34 to 57 years
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Methotrexate
- How many people
- 32 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jan 2018to 30 Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 34 to 57 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients with psoriatic changes in nails with distal interphalangeal extensor tendon enthesopathy in ultrasound examination
Who may be able to join
- 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
Who cannot join
- Patients diagnosed with osteoarthritis of hands, those who work hard physically and those with changes in nails other than caused by psoriasis
Trial locations and contacts
1 site in 1 country.
Poland1 site
University of Warmia and Mazury
Olsztyn, Warmian-Masurian Voivodeship, 10-900
About this study
Official title: 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.
Read the 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.
- Conditions
- Nail Psoriasis
- Being tested
- Methotrexate
- Keywords
- Distal Interphalangeal Joint Extensor Tendon Enthesopathy, Nail Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Methotrexate Ebeve, Metex,
Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Effect of Methotrexate on Morphological Changes in Psoriatic Nails
Ultrasonographic assessment of the effect of methotrexate on morphological changes in psoriatic nails
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2018
- Study start7 Jan 2018
- Primary completion30 Sep 2018
- Study completion30 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryszard Górecki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ryszard Górecki, University of Warmia and Mazury
- Investigators
- Magdalena Krajewska-Włodarczyk, PhD, Principal investigator, University of Warmia and Mazury
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03757364
- Sponsor's protocol ID
- UWM/Ps-ENTH.2018/001
- Status last verified
- Nov 2018
- First submitted
- 25 Nov 2018
- Last updated
- 28 Nov 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30271786McGonagle 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.
PubMed 19060455
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Methotrexate in the Treatment of Distal Interphalangeal Joint Extensor Tendon Enthesopathy in Patients With Nail Psoriasis
- ClinicalTrials.gov ID
- NCT03757364
- Acronym / sponsor ID
- UWM/Ps-ENTH.2018/001
- Conditions
- Nail Psoriasis
- Keywords
- Distal Interphalangeal Joint Extensor Tendon Enthesopathy, Nail Psoriasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Ryszard GóreckiUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Sep 2018 (actual)
- First posted
- 28 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the study is to assess the effect of methotrexate on the development of distal interphalangeal joint extensor tendon enthesopathy.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 19 patients with Ps | – | Drug: Methotrexate19 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 |
| 13 patients with PsA | – | Drug: Methotrexate13 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 |
Who may qualify
- Ages
- 34 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients with psoriatic changes in nails with distal interphalangeal extensor tendon enthesopathy in ultrasound examination
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Patients diagnosed with osteoarthritis of hands, those who work hard physically and those with changes in nails other than caused by psoriasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: Methotrexate Ebeve, Metex,Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis | Drug | 13 patients with PsA, 19 patients with Ps |
Primary outcome
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.
1 secondary outcome
Effect of Methotrexate on Morphological Changes in Psoriatic Nails
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2018.
- Background: PubMed 30271786Krajewska-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.
- Background: PubMed 19060455McGonagle 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.
- Ultrasound Assessment of Changes in Nails in Psoriasis and Psoriatic ArthritisLink provided by the sponsor.
- The link between psoriasis and arthritisLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Krajewska-Włodarczyk, PhD principal investigator
University of Warmia and Mazury
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nail Psoriasis, run by Ryszard Górecki at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Methotrexate on Distal Interphalangeal Joint Extensor Tendon Enthesopathy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03757364, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2018.