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Rheumatoid ArthritisNCT05119452

Screening for Flare After b/tsDMARD Discontinuation in Rheumatoid Arthritis

A study testing Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) in people with Rheumatoid Arthritis, run by Medical University of Vienna.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
No sites listed yet
Study dates
Mar 2022to Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Willing and able to understand and follow the study procedures
  • Written informed consent
  • Female and male subjects aged ≥ 18 years

Who cannot join

  • 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

About this study

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

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.

Read the detailed 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.

Being tested
Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

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

Study groups in NCT05119452
Study groupRoleWhat they receive
Assisted monitoringOtherIn 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.
Receives: Other: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)
Clinical monitoringOtherIn 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.
Receives: Other: Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects without a clinical flare until week 24

    Proportion of subjects without a clinical flare

    Measured: week 24

Secondary outcomes (15)

  1. Proportion of subjects without a clinical flare

    Proportion of subjects without a clinical flare

    Measured: week 48

  2. Time to clinical flare (days)

    Time to clinical flare (days)

    Measured: study period

  3. 28 swollen joint count

    28 swollen joint count, scale 0 (best) - 28 (worse)

    Measured: week 24

  4. 28 tender joint count

    28 tender joint count, scale 0 (best) - 28 (worse)

    Measured: week 24

  5. 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

    Measured: week 24

  6. 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

    Measured: week 24

  7. 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

    Measured: week 48

  8. Patient's global assessment

    Patient's global assessment, scale 0 (best) - 100 (worst)

    Measured: week 24

  9. Evaluator's global assessment

    Evaluator's global assessment, scale 0 (best) - 100 (worst)

    Measured: week 24

  10. C-reactive protein

    C-reactive protein, scale 0 (best) - infinite (worst)

    Measured: week 24

  11. Radiographic progression

    change in Sharp Van der Heijde score, scale 0 (best) - 488 (worse)

    Measured: at week 48 weeks from baseline

  12. Health Assessment Questionnaire Disability Index

    Health Assessment Questionnaire Disability Index, scale 0 (best) - 3.0 (worse)

    Measured: week 24

  13. World Health Organization Quality of Life Questionnaire

    World Health Organization Quality of Life Questionnaire, scale 0 (worse) - 100 (best)

    Measured: week 24

  14. Morning stiffness

    Morning joint stiffness, (minutes), scale 0 (best) - infinite (worst)

    Measured: week 24

  15. Fatigue

    Fatigue, visual analogue scale, scale 0 (worse) - 100 (best)

    Measured: week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2021
  2. Study startMar 2022 (estimated)
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
85 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05119452
Sponsor's protocol ID
1389/2020
Status last verified
Nov 2021
First submitted
2 Nov 2021
Last updated
15 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Discontinuation of biological/targeted synthetic disease modifying anti-rheumatic drug (b/tsDMARD) in people with Rheumatoid Arthritis, run by Medical University of Vienna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects without a clinical flare until week 24 (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05119452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.

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