Handscan optical measurements in Rheumatoid Arthritis: an inventory comparing serum levels of CRP, ESR, IL-6, clinical arthritis and reproducibility of DAS28.

Handscan optical measurements in Rheumatoid Arthritis: an inventory comparing serum levels of CRP, ESR, IL-6, clinical arthritis and reproducibility of DAS28. - HANDRAIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49310

Enrollment

Registered

2020-12-10

Start date

2020-07-01

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

reumatoïd arthritis rheumatism

Interventions

Investigational product/ treatment Early MTX naive RA patients will be randomized in three subgroups: I. methotrexate 15 mg once a week monotherapy II. methotrexate plus methylprednisolone 120 mg IM

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Able and willing to give written informed consent - Patients aged >= 18 years - Recent (

Exclusion criteria

Exclusion criteria: - Deformity of the hand or an allergy to light is an exclusion criteria for valid use of the Handscan - A recent ( 2 × ULN Serum alanine transaminase (ALT) > 2 × ULN Estimated glomerular filtration rate (GFR) by simplified 4-variable Modification of Diet in Renal Disease (MDRD) formula

Design outcomes

Primary

Measure	Time frame
Sensitivity to change of the Handscan during consecutive visits after initiation of different treatment strategies. In this, the percentage of patients with an initial response detected by the Handscan ( = at least 2 points reduction in TOS) at the different moments in time will be determined (% initial response at week 1 (early), week 3 (early), week 6 (intermediate), week 9 (late), week 12 ( late), respectively).	—

Measure

Time frame

Sensitivity to change of the Handscan during consecutive visits after initiation of different treatment strategies. In this, the percentage of patients with an initial response detected by the Handscan ( = at least 2 points reduction in TOS) at the different moments in time will be determined (% initial response at week 1 (early), week 3 (early), week 6 (intermediate), week 9 (late), week 12 ( late), respectively).

—

Secondary

Measure	Time frame
9.1.2 Secondary study parameters/endpoints - Sensitivity to change of the currently used parameters SJC, TJC, DAS28, CRP, BSE and IL-6 during the consecutive visits after initiation of different treatment strategies. In this, the same endpoint parameter will be used with the applicable response definition for each of the instruments. - Difference in response time between Handscan response detection and response detection by the currently used instruments. Differences will be categorized as within patient difference in response time (Handscan response x weeks earlier to x weeks later) - Handscan TOS and SJC, TJC, DAS28, CRP, BSE and IL-6 at baseline and during the consecutive visits. - Defining the Handscan optical scores in untreated early RA patients at baseline - Establish reproducibility of Handscan measurements with interobserver variability of DAS28 - Association between Handscan total optical score and DAS28 - Describing the effects of Sarilumab therapy in MTX naïve patients compared to the monotherapy MTX group - Establish IL-6 levels with rate of severity of arthritis activity, DAS28 categories	—

Measure

Time frame

9.1.2 Secondary study parameters/endpoints - Sensitivity to change of the currently used parameters SJC, TJC, DAS28, CRP, BSE and IL-6 during the consecutive visits after initiation of different treatment strategies. In this, the same endpoint parameter will be used with the applicable response definition for each of the instruments. - Difference in response time between Handscan response detection and response detection by the currently used instruments. Differences will be categorized as within patient difference in response time (Handscan response x weeks earlier to x weeks later) - Handscan TOS and SJC, TJC, DAS28, CRP, BSE and IL-6 at baseline and during the consecutive visits. - Defining the Handscan optical scores in untreated early RA patients at baseline - Establish reproducibility of Handscan measurements with interobserver variability of DAS28 - Association between Handscan total optical score and DAS28 - Describing the effects of Sarilumab therapy in MTX naïve patients compared to the monotherapy MTX group - Establish IL-6 levels with rate of severity of arthritis activity, DAS28 categories

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)