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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.
Register: EUCTR
Last refreshed on: 15 October 2018
Main ID:  EUCTR2012-000139-21-AT
Date of registration: 23/04/2012
Prospective Registration: Yes
Primary sponsor: Medizinische Universität Wien, Universitätsklinik für Innere Medizin III
Public title: Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action
Scientific title: A Randomized, Multi-Center Biomarker Trial to Predict Therapeutic Responses of Patients with Rheumatoid Arthritis to a Specific Biologic Mode of Action - BioBio
Date of first enrolment: 14/05/2012
Target sample size:
Recruitment status: Not Recruiting
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000139-21
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: no
Randomised: yes
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: 4
 
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 Czech Republic Russian Federation Slovakia Switzerland
Contacts
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Key inclusion & exclusion criteria
Inclusion criteria:
1) Men and women, =18 and =75 years of age, capable of understanding and signing an informed consent.
2) Classifiable RA according to the 2010 ACR/EULAR criteria or 1987 ARA criteria (present or past)
3) Duration of RA =3 years
4) Ongoing conventional DMARD therapy with methotrexate (at least 20mg/week, or lower if not tolerated in higher doses) or leflunomide (=100mg/week), for =6 months or =3 months with documented worsening of disease activity.
5) Clinical Disease Activity Index (CDAI)=15 corresponding to moderate to severe disease activity.
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 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Patients must not
1) Be incapacitated, largely or wholly bedridden, or confined to a wheelchair, or have little or no ability for self care.
2) Weigh more than 100 kg
3) Use glucocorticoids >10 mg/day prednisone or equivalent
4) Have previously received other treatments for their rheumatic disease:
a) intra-muscular or intra-articular injection of steroids in the previous month.
b) monoclonal antibodies or antibody fragments, licenced or investigational
c) any investigational drug within 3 months prior to screening or within 5 half-lives of the investigational agent, whichever is longer.
d) Azathioprine or other cytostatic drugs.
5) Have a history of receiving human/murine recombinant products or a known allergy to murine products.
6) Have documentation of seropositivity for human immunodeficiency virus (HIV), or a positive test for hepatitis B surface antigen or hepatitis C ¬antibodies.
7) Have hypergammaglobulinemia
8) Have a history of alcohol or substance abuse within the preceding 6 months.
9) Have or have had a known history of
a) serious infections (such as, but not limited to hepatitis, pneumonia, or pyelonephritis) in the previous 3 months.
b) opportunistic infections (eg, herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 12 months prior to screening.
c) a chronic or recurrent infectious disease (eg, chronic renal infection, chronic chest infection, COPD, sinusitis, recurrent urinary tract infection, open, draining or infected skin wound or ulcer etc.).
10) Have undergone any joint replacement surgery.
11) Be men and women of childbearing potential without use of adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, implantable or injectable contraceptives or surgical sterilization), and willingness to continue this precaution for the duration of the study until 6 months after receiving the last medication.
12) Be considered ineligible according to the tuberculosis (TB) eligibility assessment and screening, or show a positive test for latent Tbc using Quantiferon assay, unless treatment with INH has been installed for at least 2 weeks prior to starting trial drug.
13) Show evidence of malignancy, or lymphoproliferative disease, or any history of malignancy within the previous 5 years, with the exception of basal cell or squamous cell carcinoma of the skin that has been fully excised with no evidence of recurrence.
14) Have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, or cerebral disease.
15) Be unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access.
16) Have presence of a transplanted solid organ (with the exception of a corneal transplant > 3 months prior to screening).
17) Have a concomitant diagnosis or history of congestive heart failure (NYHA class III or IV) or diverticulitis.
18) Have a known history of a demyelinating disease, such as multiple sclerosis.
19) Be women who are pregnant, nursing, or planning pregnancy within 6 months after the last infusion



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

Trade Name: Remicade
Product Name: Remicade
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Concentration unit: millilitre(s)/gram
Concentration type: up to
Concentration number: 100-5

Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 250-

Trade Name: Ro-Actemra
Product Name: Ro Actemra
Pharmaceutical Form: Concentrate for solution for infusion
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: Mabthera
Product Name: Mabthera
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Trade Name: Orencia
Product Name: Orencia
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ABATACEPT
CAS Number: 332348-12-6
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 125-

Trade Name: Ro-Actemra
Product Name: Ro Actemra
Pharmaceutical Form: Solution for injection
CAS Number: 375823-41-9
Other descriptive name: TOCILIZUMAB
Concentration unit: millilitre(s)/gram
Concentration type: equal
Concentration number: 162-

Primary Outcome(s)
Main Objective: We hypothesize that a trial employing biologicals in a parallel, randomized way, allows finding biomarkers for prediction of optimal response to each of these drugs.
.
Primary end point(s): Absolute change in the Simplified Disease Activity Index (SDAI) after 24 weeks.
Secondary Objective: To identify a set of clinical and biological markers can be identified that allows the definition of a therapeutic mode of action for a given patient with RA
Timepoint(s) of evaluation of this end point: 24 weeks, 48 weeks
Secondary Outcome(s)
Secondary end point(s): - Relative change in the SDAI after 24 weeks in percent.
- Absolute and relative change in the Clinical Disease Activity Index (CDAI) after 24 weeks in percent.
- Absolute and relative change in the Disease Activity Score 28 (DAS28) after 24 weeks in percent.
- Achieving an SDAI or CDAI response (50%, 70%, 85%)
- Achieving a EULAR response
- Achieving an ACR response (20%, 50%, 70%)
- Change in quality of life (EuroQoL-5D, SF-36) and physical function (HAQ)
- Change in fatigue and sleep
- Proportion achieving a low disease activity state (SDAI =11) after 24 weeks
- Proportion achieving a remission state (SDAI =3.3) after 24 weeks
- Radiographic progression over 6 months / 12 months

Timepoint(s) of evaluation of this end point: 6 months, 12 Months
Secondary ID(s)
BIOBIO-Study
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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