Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Josef Smolen


Contact details

Medical University of Vienna
Waehringer Guertel 18-20
+43 (0) 1 40 400 4381

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



Study hypothesis

To investigate the efficacy of treatment in real life (routine clinical care) with rituximab (MabThera®) in patients with active Rheumatoid Arthritis (RA) whose current treatment with a Tumour Necrosis Factor (TNF)-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalumimab - Humira®) in combination with Methotrexate (MTX) is insufficient.

Ethics approval

Ethical committee and internal review board of the Medical University of Vienna (reference Number 049/2006), date of approval: 14/03/2006.

Study design

A clinical observational real-life study investigating the effect of Rituximab

Primary study design


Secondary study design


Trial setting

Not specified

Trial type


Patient information sheet


Rheumatoid Arthritis (RA)


Infusion with rituximab (MabThera®)

Intervention type



Phase II/III

Drug names

Rituximab (MabThera®), Etanercept (Enbrel®), Infliximab (Remicade®), Adalumimab (Humira®) and Methotrexate (MTX)

Primary outcome measure

Primary outcome measure will be the frequency of reaching low disease activity or remission as measured by the Clinical Disease Activity Index (CDAI) (less than or equal to ten).

Secondary outcome measures

1. Major CDAI response of -13.9
2. Moderate CDAI response of -6.7
3. Disease Activity Score based on 28 joints (DAS28)
4. Simplified Disease Activity Index (SDAI)
5. American College of Rheumatology (ACR) response criteria (20%, 50%, 70%)
6. Health Assessment Questionnaire (HAQ)
7. Short Form Health Sruvey (SF-36)

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Women or men 18 years of age or older
2. Diagnosis of RA according to the revised 1987 criteria of the American Rheumtololgy Association (ARA) for at least three months prior to first administration of study medication
3. The current treatment with Etanercept, Infliximab or Adalimumab in combination with MTX is insufficient. The patient’s disease is considered to be active despite Disease Modifying Anti-Rheumatic Drug (DMARD) treatment
4. Active disease at the time of screening as defined by:
a. more than or equal to six swollen joints on a 66/68 joint count
b. more than or equal to six tender joints on a 66/68 joint count
c. and one out of the following three categories:
i. Erythrocyte Sedimentation Rate (ESR) more than or equal to 28 mm/h
ii. C-Reactive Protein (CRP) more than or equal to 1.5 mg/dl
iii. Morning stiffness more than or equal to 45 minutes
d. and one out of the following three categories:
i. bone erosion by x-ray prior to first administration of study medication
ii. Anti-Cyclic Citrullinated Peptide (Anti-CCP) antibody-positive
iii. Rheumatoid Factor (RF)-positive at screening
5. If using Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or other analgesics for RA, must be on a stable dose for at least two weeks prior to the first administration of study agent
6. If using oral corticosteroids, must be on a stable dose equivalent to less than or equal to 10 mg of prednisone/day for at least two weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least two weeks prior to first administration of study medication
7. Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (e.g., abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilisation) during the study and for six months after receiving the last administration of study agent
8. Female subjects of childbearing potential must test negative for pregnancy. A pregnancy test will be performed at the beginning and at the end of the study
9. The screening laboratory test must meet the following criteria:
a. haemoglobin more than or equal to 8.5 g/dl providing the low haemoglobin level is not due to other diseases than anemia of chronic inflammation
b. White Blood Cells (WBC) more than or equal to 3500/µl
c. neutrophils more than or equal to 1500/µl
d. platelets more than or equal to 100,000/µl
e. serum transaminase less than or equal to two times the Upper Limit of Normal (ULN)
f. serum creatinine less than or equal to 1.7 mg/dl
10. The patient must be able to adhere the study visit schedule and other protocol requirements and must have given informed consent prior to any screening procedures

Participant type


Age group




Target number of participants


Participant exclusion criteria

Patients are excluded if they meet one of the following criteria:
1. Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment
2. Patients with other inflammatory diseases that might interfere with the evaluation of the RA
3. Patients with fibromyalgia syndrome
4. Use of IntraMuscular (IM), IntraVenous (IV), IntraArterial (IA) corticosteroids within four weeks prior to screening
5. Treatment with any investigational drug within three months prior to screening
6. A history of known allergy to murine proteins, e.g. allergy to Infliximab
7. History of infected joint prothesis within the previous five years
8. Chronic infections
9. History of active tuberculosis requiring treatment within the previous three years, or history of opportunistic infections within two months, uncontrolled active infection or documented Human Immunodeficiency Virus (HIV) infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis (TB) without documented adequate therapy if they will not be treated according to the local TB guidelines
10. Current signs or symptoms of other severe uncontrolled disease which in the investigators opinion would put the patient at an unacceptable risk
11. History of lymphoproliferative disease, any current malignancies or history of malignancy within five years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin
12. History of drug abuse

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

Medical University of Vienna

Sponsor information


Medical University of Vienna (Austria)

Sponsor details

c/o Prof. Dr. Josef Smolen
Waehringer Guertel 18-20
+43 (0) 1 40 400 4381

Sponsor type




Funder type


Funder name

The trial is an investigator driven study without any grant support, Roche provides the medication.

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes