Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?

Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005204-15-AT

Enrollment

110

Registered

2012-05-15

Start date

2012-06-20

Completion date

Unknown

Last updated

2020-12-07

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

Conditions

biological DMARDs may be stopped in RA patients treated with a combination of synthetic DMARD plus biological DMARDs which are in persistent clinical remission. Ultrasound may be useful to predict a disease flare in patients stopping biological DMARDs therapy. MedDRA version: 20.0 Level: LLT Classification code 10039076 Term: Rheumatoid arthritis and other inflammatory polyarthropathies System Organ Class: 100000004859

Interventions

Trade Name: Remicade Pharmaceutical Form: Powder for concentrate for solution for infusion INN or Proposed INN: INFLIXIMAB CAS Number: 170277-31-3 Concentration unit: mg milligram(s) Concentration ty

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Male or female patients =18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 35

Exclusion criteria

Exclusion criteria: 1. Current treatment with any investigational drug 2. Current administration interval of the bDMARD of >11 weeks 3. Complete destruction of any joint to be investigated by sonography 4. Severe systemic (i.e. extraarticular) RA- manifestation 5. Begin of arthritis before age of 17 years 6. Planned surgery within the study period or history of surgery of any joint to be investigated clinically or by sonography 7. Current severe medical illness requiring hospitalization 8. Active infection or active malignancy 9. Pregnancy or lactation 10. Inability of the patient to follow the protocol 11. Current treatment with Rituximab (MabThera®)

Design outcomes

Primary

Measure	Time frame
Main Objective: Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 16.;Secondary Objective: 1./2.Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 24 / 52 3.RA-patients have higher PD at time of a clinical flare compared to patients with maintained clinical remission 4.An increment of PD at follow-up compared to baseline visits precedes a clinical flare 5.PD-scores better predict a relapse than the presence of residual swollen joints 6.The higher the PD at baseline, the more likely is a relapse at weeks 16, 24 and/or 52 7.Patients converting from a rheumatoid factor (RF) positive to a RF negative status are less likely to experience a relapse at weeks 16, 24 and 52 than patients remaining seropositive 8./9.Blood biomarkers predict the time to flare after bDMARD withdrawal/ to re-achieve remission after flare and re-induction of bDMARD treatment 10.PD-scores and blood biomarkers at baseline predict radiographic progression at week 52 ;Primary end point(s): Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 16.;Timepoint(s) of evaluation of this end point: week 16 after bDMARDs withdrawal	—

Measure

Time frame

Main Objective: Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 16.;Secondary Objective: 1./2.Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 24 / 52 3.RA-patients have higher PD at time of a clinical flare compared to patients with maintained clinical remission 4.An increment of PD at follow-up compared to baseline visits precedes a clinical flare 5.PD-scores better predict a relapse than the presence of residual swollen joints 6.The higher the PD at baseline, the more likely is a relapse at weeks 16, 24 and/or 52 7.Patients converting from a rheumatoid factor (RF) positive to a RF negative status are less likely to experience a relapse at weeks 16, 24 and 52 than patients remaining seropositive 8./9.Blood biomarkers predict the time to flare after bDMARD withdrawal/ to re-achieve remission after flare and re-induction of bDMARD treatment 10.PD-scores and blood biomarkers at baseline predict radiographic progression at week 52 ;Primary end point(s): Active inflammation at the time of bDMARDs withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 16.;Timepoint(s) of evaluation of this end point: week 16 after bDMARDs withdrawal

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Secondary

Measure	Time frame
Secondary end point(s): 1. Active inflammation at the time of bDMARD withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 24. 2. Active inflammation at the time of bDMARD withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 52. 3. RA-patients have higher PD-scores at the time of a clinical flare compared to patients with maintained clinical remission. 4. An increment of PD-scores at follow-up compared to baseline visits precedes a clinical flare 5. PD-scores better predict a relapse than the presence of residual swollen joints 6. The higher the PD score at baseline, the more likely is a relapse at weeks 16, 24 and/or 52 7. Patients converting from a rheumatoid factor (RF) positive to a RF negative status are less likely to experience a relapse at weeks 16, 24 and 52 than patients remaining seropositive 8. Blood biomarkers predict the time to flare after bDMARD withdrawal 9. Blood biomarkers predict the time to re-achieve remission after flare and re-induction of bDMARD treatment 10. PD-scores and blood biomarkers at baseline predict radiographic progression at week 52 ;Timepoint(s) of evaluation of this end point: 1. week 16 after bDMARDs withdrawal 2. at time of clinical flare 3. at baseline	—

Measure

Time frame

Secondary end point(s): 1. Active inflammation at the time of bDMARD withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 24. 2. Active inflammation at the time of bDMARD withdrawal indicated by the presence of a PD-score =1 in at least one joint out of a sonographic 14-joint count predicts relapse rate at week 52. 3. RA-patients have higher PD-scores at the time of a clinical flare compared to patients with maintained clinical remission. 4. An increment of PD-scores at follow-up compared to baseline visits precedes a clinical flare 5. PD-scores better predict a relapse than the presence of residual swollen joints 6. The higher the PD score at baseline, the more likely is a relapse at weeks 16, 24 and/or 52 7. Patients converting from a rheumatoid factor (RF) positive to a RF negative status are less likely to experience a relapse at weeks 16, 24 and 52 than patients remaining seropositive 8. Blood biomarkers predict the time to flare after bDMARD withdrawal 9. Blood biomarkers predict the time to re-achieve remission after flare and re-induction of bDMARD treatment 10. PD-scores and blood biomarkers at baseline predict radiographic progression at week 52 ;Timepoint(s) of evaluation of this end point: 1. week 16 after bDMARDs withdrawal 2. at time of clinical flare 3. at baseline

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Countries

Austria

Contacts

Public ContactAuskunft Klinische Studie

Med Uni Graz, Univ. Klinik Innere Medizin, Abt. Rheumatologie

kks@medunigraz.at43316385 12645

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026