Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis

NCT05119452 | Unknown

• 1 other identifier: 1389/2020
• Study Type: interventional
• Target: 85
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects without a clinical flare until week 24

  Proportion of subjects without a clinical flare

  week 24

Secondary Outcomes (15)

• Proportion of subjects without a clinical flare

  week 48

• Time to clinical flare (days)

  study period

• 28 swollen joint count

  week 24

• 28 tender joint count

  week 24

• 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

Study Arms (2)

Assisted monitoring

OTHER

In the Assisted monitoring arm, C-reactive protein and musculoskeletal ultrasound information will be made available to the clinical assessors who, at each time-point will use this information, along with information from the clinical examination, to identify patients experiencing recurrence of inflammation which will then be counted as subclinical flare according to predefined criteria.

Other: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)

Clinical monitoring

OTHER

In the Clinical monitoring arm, the results of C-reactive protein and musculoskeletal ultrasound information will be recorded but will not be made available to the clinical assessor who at each time-point will make the decision on whether the patient is experiencing or has experienced a clinical flare according to predefined criteria based on information from the clinical examination.

Other: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)

Interventions

Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) OTHER

The biological/targeted synthetic disease modifying anti-rheumatic drug will be discontinued in both arms at baseline

Also known as: b/tsDMARD: Adalimumab, Infliximab, Golimumab, Certolizumab pegol, Tocilizumab, Sarilumab, Etanercept, Anakinra, Filgotinib, Updacitinib, Tofacitinib, Baricitinib

Assisted monitoring; Clinical monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead
• Medical University of Graz: collaborator
• Medical University Innsbruck: collaborator
• Hospital Hietzing: collaborator
• Krankenhaus Bruneck: collaborator

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Infliximab; golimumab; Certolizumab Pegol; tocilizumab; sarilumab; Etanercept; Interleukin 1 Receptor Antagonist Protein; GLPG0634; tofacitinib; baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Antibodies, Monoclonal, Humanized; Immunoglobulin Fc Fragments; Immunoglobulin Constant Regions; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Cytokines; Intercellular Signaling Peptides and Proteins; Biological Factors

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: After checking the inclusion- and exclusion criteria and after the patients´ consent the study investigator contacts the administrative office of the coordinating center. The online computerised randomisation algorithm "Randomizer for Clinical Trials by the Medical University of Vienna (MUW) will be used for randomisation for all centres.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ap. Prof. Priv.-Doz. Dr. Peter Mandl

Model Details: At baseline, patients will be randomised in a 1:1 ratio in an "Assisted monitoring" (arm A) or a "Clinical monitoring" (arm B) arm respectively.

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: November 15, 2021
• Study Start: March 1, 2022
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: November 15, 2021

Record last verified: 2021-11