Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630715
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy Of Upadacitinib In Psoriatic Arthritis And Comparison To Rheumatoid Arthritis OPTimising IMAging For The Use In The Follow-Up Of Arthritis The OPTIMA Study
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPTIMA
Brief Summary:
The general objective of the OPTIMA study is to assess the time course and interrelationship of imaging ultrasound and magnetic resonance imaging clinical laboratory and Patient Reported Outcome variables in patients with active Psoriatic Arthritis any subset and Rheumatoid Arthritis starting therapy with a Jak-Inhibitor Upadacitinib during the first 6 months of follow-up
Participants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks 1 3 and 6 months post-treatment initiation At each visit with the exception of the 2-weeks visit data relating to the clinical evaluation laboratory tests and ultrasound of the affected joints will be collected according to standard clinical practice questionnaires on disease activity will also be completed In the case of axial involvement a magnetic resonance imaging will be performed at baseline and after 6 months of therapy only if required by the standard of care
Participants will be evaluated at the start of therapy with upadacitinib and during the follow-up visits at 2 weeks 1 3 and 6 months post-treatment initiation At each visit with the exception of the 2-weeks visit data relating to the clinical evaluation laboratory tests and ultrasound of the affected joints will be collected according to standard clinical practice questionnaires on disease activity will also be completed In the case of axial involvement a magnetic resonance imaging will be performed at baseline and after 6 months of therapy only if required by the standard of care
Detailed Description:
This is a multicentric prospective observational study in which consecutive patients diagnosed with Psoriatic Arthritis any subset and Rheumatoid Arthritis that according to clinicians evaluation should be treated with Upadacitinib therapy will be recruited from the outpatient clinic of the Rheumatology Department of the centers included in the study
The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria from the outpatient clinic of the Rheumatology Units of the participating centers Written informed consent will be obtained prior to the beginning of the study All patients in line with clinical routine practice will undergo a standard clinical laboratory and imaging assessment in order to define the disease activity according to standardized disease activity indexes at baseline and during the first 3 follow-up visits For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis the follow-up visits are generally scheduled after 1 month 1 week 3 months 2 weeks and 6 months 4 weeks post-treatment initiation in accordance with international guidelines and local protocols In case of suspicion of axial involvement an MRI of the sacroiliac joints will be performed at baseline and in case of positivity will be repeated after 6 months 1 month in order to assess disease activity at the spine and the treatment efficacy Regarding the Patient Reported Outcome the investigators will assess these during the scheduled visits and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit and subsequently participants will return these during the first follow-up visit The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form
The investigators will enroll consecutive patients with Psoriatic Arthritis and Rheumatoid Arthritis with active disease and fulfilling the inclusion and exclusion criteria from the outpatient clinic of the Rheumatology Units of the participating centers Written informed consent will be obtained prior to the beginning of the study All patients in line with clinical routine practice will undergo a standard clinical laboratory and imaging assessment in order to define the disease activity according to standardized disease activity indexes at baseline and during the first 3 follow-up visits For patients starting new treatments for Psoriatic Arthritis and Rheumatoid Arthritis the follow-up visits are generally scheduled after 1 month 1 week 3 months 2 weeks and 6 months 4 weeks post-treatment initiation in accordance with international guidelines and local protocols In case of suspicion of axial involvement an MRI of the sacroiliac joints will be performed at baseline and in case of positivity will be repeated after 6 months 1 month in order to assess disease activity at the spine and the treatment efficacy Regarding the Patient Reported Outcome the investigators will assess these during the scheduled visits and two weeks after the initiation of treatment to evaluate earlier pain and functional improvement The Patient Reported Outcome assessment at two weeks will be administered in a paper form to participants during the baseline visit and subsequently participants will return these during the first follow-up visit The data for the study will be retrieved from the medical records of participants and recorded into an appositely created electronic case report form
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None