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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT01602302
Date of registration: 16/05/2012
Prospective Registration: Yes
Primary sponsor: Medical University of Graz
Public title: Ultrasound and Withdrawal of Biological DMARDs in Rheumatoid Arthritis RA-BioStop
Scientific title: Ultrasound as Biomarker for Withdrawal of Biological DMARDs in Rheumatoid Arthritis
Date of first enrolment: June 2012
Target sample size: 40
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 4
Countries of recruitment
Name:     Christian Dejaco, MD, PhD
Affiliation:  Medical University of Graz
Key inclusion & exclusion criteria

Inclusion Criteria:

- Male or female patient =18 years and <90 years of age

- Classification of RA according to the ACR/EULAR 2010 criteria

- Persistent clinical remission as defined by the ACR/EULAR remission criteria for at
least 6 months (documented at =2 visits)

- Written informed consent

- Current treatment with a single csDMARD or a combination of csDMARDs plus a stable
dose and administration interval (for the last 6 months) of a TNF-alpha inhibitor

- No current systemic corticosteroid treatment (stopped for at least 4 weeks), no
corticosteroid injection within 4 weeks

- Stable dose of NSAIDs for at least 1 week

Exclusion Criteria:

- • Current treatment with any investigational drug

- Current administration interval of the anti-TNF-alpha agent of >11 weeks

- Complete destruction of any joint to be investigated by sonography

- Current RA-related vasculitis or other active systemic (i.e. extraarticular) RA-
manifestation with the exception of rheumatoid nodules

- Initial arthritis manifestations before the age of 17 years

- Planned surgery within the study period or history of surgery of any of the joints to
be investigated clinically or by sonography

- Current severe medical illness requiring hospitalization

- Active infection or active malignancy at screening or infection during the past 4
weeks requiring (even temporary) discontinuation of the anti-TNF-alpha agent

- Pregnancy or lactation

- Inability of the patient to follow the protocol

- Current treatment with Rituximab (MabThera®)

Age minimum: 18 Years
Age maximum: 90 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis
Drug: bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)
Primary Outcome(s)
PD-signals predict relapse at week 16 [Time Frame: 16 weeks]
Secondary Outcome(s)
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 [Time Frame: 16, 24, 52 weeks]
8. Blood biomarkers predict the time to flare after bDMARD withdrawal [Time Frame: 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 [Time Frame: 9. Blood biomarkers predict the time to re-achieve remission after flare and re-induction of bDMARD treatment]
Increment of PD-scores precede flare [Time Frame: 52 weeks]
PD score at baseline correlates with relapse risk [Time Frame: 52 weeks]
PD scores better predict a relapse than residual swollen joints [Time Frame: 16, 24, 52 weeks]
PD-scores and blood biomarkers at baseline predict radiographic progression at week 52 [Time Frame: 52]
PD-scores at time of relapse [Time Frame: 24 weeks]
PD-signals predict relapse at week 24 [Time Frame: 24 weeks]
PD-signals predict relapse at week 52 [Time Frame: 52 weeks]
Secondary ID(s)
2011-5; V2
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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