Recruiting

Observational Study

Sponsor:

Charite University, Berlin, Germany

Code:

NCT04434885

Conditions

Psoriatic Arthritis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Clinical and imaging examination of symptoms and signs suggestive of axial involvement

Study Details

Brief summary:

This is a multinational multicenter cross-sectional study in patients with a definite diagnosis of PsA. The population of interest will consist of 400 adult patients diagnosed with PsA and fulfilling the classification criteria for PsA and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs). Participating rheumatologists are encouraged to include consecutive PsA patients not treated with biologic or a targeted synthetic disease-modifying antirheumatic drug because of their potential impact on active inflammatory changes in the axial skeleton, which will be the focus of the current study. Patients will be recruited prospectively in selected study centres and will undergo study-related examinations including imaging of the axial skeleton (X-rays and magnetic resonance imaging). Collected data will serve as a basis for the judgement on the presence or absence of axial involvement by the local investigator and, independently, by the central study committee.

Conditions

Psoriatic Arthritis

Study ID

NCT04434885

Start date

Jul 1, 2021

Status verified date

Jun, 2022

Completion date

Dec, 2023

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age >=18 years.
  • Definite diagnosis of PsA.
  • Fulfilment of the CASPAR criteria for PsA.
  • Duration of PsA symptoms ≤10 years.
  • Written informed consent.

Exclusion Criteria:

  • Unable or unwilling to give informed consent or to comply with the protocol.
  • Current or past treatment with biologic or a targeted synthetic disease-modifying antirheumatic drug (DMARDs).
  • Contraindications for MRI and/or plain X-ray examination of sacroiliac joints and spine.

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Arms

Psoriatic arthritis

Patients diagnosed with PsA and fulfilling the classification criteria for PsA with symptom duration of up to 10 years and not receiving biological or targeted synthetic disease modifying antirheumatic drugs (b or tsDMARDs).

Interventions

Clinical and imaging examination of symptoms and signs suggestive of axial involvement

Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine

Primary outcome measure

  • The prevalence of axial involvement by local investigator [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Denis Poddubnyy, MD

+4930450514582denis.poddubnyy@charite.de

Dafna D. Gladman, MD, FRCPC

+14166035753dafna.gladman@utoronto.ca

Locations

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

Charite University, Berlin, Germany

Last update posted

Jun 27, 2022

Last verified

Jun, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Charite University, Berlin, Germany on 2022-06-27. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.