World Health Organization site
Skip Navigation Links

Main
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.
Register: EUCTR
Last refreshed on: 7 December 2020
Main ID:  EUCTR2011-005204-15-AT
Date of registration: 15/05/2012
Prospective Registration: Yes
Primary sponsor: Med Uni Graz, Univ. Klinik Innere Medizin,Abt. Rheumatologie und Immunologie
Public title: Could ultrasound help to identify the patients with rheumatoid arthritis, in those the treatment with biological DMARDs could be stopped?
Scientific title: Ultrasound as biomarker for withdrawal of biological DMARDs in rheumatoid arthritis (RA-BioStop) - RABioStop
Date of first enrolment: 20/06/2012
Target sample size: 110
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005204-15
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 1
 
Phase:  Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes
Countries of recruitment
Austria
Contacts
Name: Auskunft Klinische Studie   
Address:  Auenbruggerplatz 15 8036 Graz Austria
Telephone: 43316385 12645
Email: kks@medunigraz.at
Affiliation:  Med Uni Graz, Univ. Klinik Innere Medizin, Abt. Rheumatologie
Name: Auskunft Klinische Studie   
Address:  Auenbruggerplatz 15 8036 Graz Austria
Telephone: 43316385 12645
Email: kks@medunigraz.at
Affiliation:  Med Uni Graz, Univ. Klinik Innere Medizin, Abt. Rheumatologie
Key inclusion & exclusion criteria
Inclusion criteria:
1. Male or female patients =18 years and <90 years of age
2. Classification of RA according to the ACR-EULAR 2010 criteria
3. Clinical remission according to ACR-EULAR remission criteria at time of inclusion and remission or low disease activity according to SDAI in the preceding 6 months
4. Written informed consent
5. Current treatment with a csDMARD plus a stable dose and administration interval (for at least 6 months) of a bDMARD
6. No current corticosteroid treatment
7. Stable dose of NSAIDs

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

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®)




Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

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 type: equal
Concentration number: 100-

Trade Name: Enbrel
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ETANERCEPT
CAS Number: 185243-69-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Trade Name: Humira
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: ADALIMUMAB
CAS Number: 331731-18-1
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 40-

Trade Name: Cimzia
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 200-

Trade Name: Simponi
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: GOLIMUMAB
CAS Number: 476181-74-5
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Trade Name: Roactemra
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB

Trade Name: Orncia
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6

Trade Name: Roactemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: tocilizumab
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB

Trade Name: Orncia
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6

Primary Outcome(s)
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.
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.
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
Timepoint(s) of evaluation of this end point: week 16 after bDMARDs withdrawal
Secondary Outcome(s)
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
Secondary ID(s)
RABioStop
Source(s) of Monetary Support
Med Uni Graz, Univ. Klinik Innere Medizin, Abt. Rheumatologie und Immunologie
Secondary Sponsor(s)
Ethics review
Status: Approved
Approval date: 13/02/2012
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history