Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

Screening for Flare After Discontinuation of Biological/Targeted Synthetic Disease Modifying Anti-rheumatic Drug (b/tsDMARD) in Rheumatoid Arthritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05119452
• Other study ID #: 1389/2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 2022
• Est. completion date: September 2024

Study information

• Verified date: November 2021
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate whether stringent follow-up consisting of combined laboratory and ultrasound surveillance is superior to clinical monitoring alone to maintain clinical remission in rheumatoid arthritis.

Description:

Randomized, controlled, parallel-group, multi-centre study in which patients with rheumatoid arthritis treated with biological/targeted synthetic disease modifying antirheumatic drug (b/tsDMARD) in mono- or combination therapy with conventional synthetic disease modifying antirheumatic drug (csDMARD) in a stable dosage and interval for ≥6 months with low disease activity or remission will receive an power Doppler musculoskeletal ultrasound examination (PDUS) and monitoring of C-reactive protein (CRP) levels at baseline and several timepoints within a 24 month study period (primary endpoint) and within a 48 month long-term extension. At baseline, b/tsDMARD medication will be withdrawn in all patients, who will be randomized in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively. Further stratification for remission vs. low disease activity and mono- vs combination therapy will be implemented in the randomisation process. In arm A, CRP and PDUS information will be made available to the clinical assessors who, at each time-point will use this information along with that from clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria. In arm B the results of CRP and PDUS will be recorded but will not be made available to the clinical assessor who will have to identify clinical flares according to predefined criteria based on information from the clinical examination only.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 85
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients with rheumatoid arthritis classified by the American College of Rheumatology/European League Against Rheumatism classification criteria

• biological disease-modifying anti-rheumatic drug (bDMARD) or targeted synthetic disease-modifying anti-rheumatic drug (tsDMARD) treatment in monotherapy or in combination therapy with conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) in a stable dosage and interval for =6 months. Previous extension of bDMARD or tsDMARD interval will also be accepted. bDMARDs and tsDMARDs will include all currently available originator and biosimilar compounds, with the exception of rituximab and its biosimilar compounds

• No swollen joint by 28-joint count at baseline, and screening

• C-reactive protein of =0.5mg/dL at baseline AND history of C-reactive protein >0,5mg/dl related to rheumatoid arthritis activity

• Clinical disease activity index =10

• Shared decision between patient and physician to attempt b/tsDMARD withdrawal

• Willing and able to understand and follow the study procedures

• Written informed consent

• Female and male subjects aged = 18 years

Exclusion Criteria:

• History of or current extra-articular manifestation of rheumatoid arthritis, with exception of rheumatoid nodules

• Systemic glucocorticoid treatment in the past 3 months

• Intraarticular injection with glucocorticoids in the past 1 month

• Joint replacement surgery other than total knee or hip arthroplasty or complete joint destruction

• Power Doppler signal =2 in any assessed joint and/or tendon at screening or baseline

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Medical University of Vienna	Hospital Hietzing, Krankenhaus Bruneck, Medical University Innsbruck, Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects without a clinical flare until week 24	Proportion of subjects without a clinical flare	week 24
Secondary	Proportion of subjects without a clinical flare	Proportion of subjects without a clinical flare	week 48
Secondary	Time to clinical flare (days)	Time to clinical flare (days)	study period
Secondary	28 swollen joint count	28 swollen joint count, scale 0 (best) - 28 (worse)	week 24
Secondary	28 tender joint count	28 tender joint count, scale 0 (best) - 28 (worse)	week 24
Secondary	Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation	Proportion of subjects with a clinical flare in the assisted monitoring arm vs. clinical monitoring arm, the latter stratified according to b/tsDMARD reinitiation	week 24
Secondary	Proportion of patients in low disease activity or remission based on simplified disease activity index	Proportion of patients in low disease activity or remission based on simplified disease activity index	week 24
Secondary	Proportion of patients in low disease activity or remission based on simplified disease activity index	Proportion of patients in low disease activity or remission based on simplified disease activity index	week 48
Secondary	Patient's global assessment	Patient's global assessment, scale 0 (best) - 100 (worst)	week 24
Secondary	Evaluator's global assessment	Evaluator's global assessment, scale 0 (best) - 100 (worst)	week 24
Secondary	C-reactive protein	C-reactive protein, scale 0 (best) - infinite (worst)	week 24
Secondary	Radiographic progression	change in Sharp Van der Heijde score, scale 0 (best) - 488 (worse)	at week 48 weeks from baseline
Secondary	Health Assessment Questionnaire Disability Index	Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)	week 24
Secondary	World Health Organization Quality of Life Questionnaire	World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)	week 24
Secondary	Morning stiffness	Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)	week 24
Secondary	Fatigue	Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)	week 24