Effect of Long-term Psoriasis on Patients' Life - CORONATE

Study Purpose

Psoriasis, is an inflammatory chronic skin disease which has a heavy physical and psychosocial impact on participant's life. This is a study to finalize and validate a questionnaire to assess the long-term effect of long-term psoriasis in adult participants. Approximately 550 adult participants with moderate to severe plaque psoriasis will be enrolled in approximately 15 dermatology centers in Italy. Participants will receive standard of care while participating in this study. No drug will be administered as a part of this study. The duration of this study is up to 22 months. There is no additional burden for participants in this study. Participants will attend regular visits during the course of the study at a hospital or clinic.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 30 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Participants with a diagnosis of moderate-to-severe plaque psoriasis (PASI≥10 or PASI<10 with involvement of sensitive areas) since at least 10 years.
  • - Adult partner in relationship with the participant since at least 3 years(Part 2 only).

Exclusion Criteria:

  • - Participants with psychiatric conditions.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05555953
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

ABBVIE INC.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

: Phase-1

The draft CORONATE questionnaire will be administered to participants to create the final version of the questionnaire.

: Phase-2

The questionnaire created in Phase 1 will be administered to a new group of participants for validation. All partners who are in a relationship with the participants since at least 3 years will be asked to participate in the study for the comparison between participants' and partners' perspectives on the impact of long-term psoriasis on participants' life.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Genoa, Genova, Italy

Status

Recruiting

Address

Ospedale Policlinico San Martino /ID# 245641

Genoa, Genova, 16132

Rome, Lazio, Italy

Status

Recruiting

Address

Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 245570

Rome, Lazio, 00168

Rome, Roma, Italy

Status

Recruiting

Address

IRCCS Istituti Fisioterapici Ospitalieri-Istituto Dermatologico San Gallicano /ID# 245116

Rome, Roma, 00144

Ancona, Italy

Status

Recruiting

Address

Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona /ID# 245117

Ancona, , 60126

Bari, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria Consorziale Policlinico /ID# 245276

Bari, , 70124

Brescia, Italy

Status

Recruiting

Address

ASST Spedali civili di Brescia /ID# 245694

Brescia, , 25123

Ospedale Piero Palagi /ID# 245569, Florence, Italy

Status

Recruiting

Address

Ospedale Piero Palagi /ID# 245569

Florence, , 50122

Ospedale Villa Scassi /ID# 245445, Genova, Italy

Status

Recruiting

Address

Ospedale Villa Scassi /ID# 245445

Genova, , 16149

L'Aquila, Italy

Status

Recruiting

Address

Presidio Ospedaliero San Salvatore /ID# 245618

L'Aquila, , 67100

Messina, Italy

Status

Recruiting

Address

A.O.U. Policlinico G. Martino /ID# 245507

Messina, , 98125

Padova, Italy

Status

Recruiting

Address

Azienda Ospedaliera di Padova /ID# 245115

Padova, , 35128

Parma, Italy

Status

Recruiting

Address

Azienda Ospedaliero-Universitaria di Parma /ID# 244950

Parma, , 43126

Ospedale Infermi di Rimini /ID# 245199, Rimini, Italy

Status

Recruiting

Address

Ospedale Infermi di Rimini /ID# 245199

Rimini, , 47923

Torino, Italy

Status

Recruiting

Address

AOU CittA della Salute e della Scienza di Torino /ID# 246438

Torino, , 10126

Verona, Italy

Status

Recruiting

Address

Azienda Ospedaliera Universitaria di Verona/Ospedale Borgo Trento /ID# 245119

Verona, , 37126

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.