Rheumatoid Arthritis
Conditions
Interventions
Trade Name: Rituximab - MabThera
Product Name: Rituximab MabThera
Product Code: no
Pharmaceutical Form: Solution for infusion
Sponsors
Vienna Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria - Women or men 18 years of age or older - Diagnosis of RA according to the revised 1987 criteria of the ARA (5) for at least 3 months prior to first administration of study medication - The current treatment with Etanercept, Infliximab or Adalimumab in combination with MTX is insufficient. The patient’s disease is considered to be active despite DMARD treatment. - Active disease at the time of screening as defined by: o = 6 swollen on a 66/68 joint count o = 6 tender joints on a 66/68 joint count o and one out of the following 3 categories ? ESR = 28 mm/ h ? CRP = 1.5 mg/ dl ? Morning stiffness = 45 min o And one out of the following 3 categories ? Bone erosion by x-ray prior to first administration of study medication ? Anti-cyclic citrullinated peptide (Anti-CCP) antibody-positive ? Rheumatoid factor (RF)-positive at screening - If using NSAIDs or other analgesics for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent. - If using oral corticosteroids, must be on a stable dose equivalent to = 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent. If currently not using corticosteroids, the subject must not have received oral corticosteroids for at least 2 weeks prior to first administration of study medication. - Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. - Female subjects of childbearing potential must test negative for pregnancy. - The screening laboratory test must meet the following criteria: o Hemoglobin = 8.5 g/ dl providing the low hemoglobin level is not due to other diseases than anemia of chronic inflammation. o WBC = 3500 / µl o Neutrophils = 1500 / µl o Platelets = 100 000 / µl o Serum transaminase = 2 times the upper limit of normal o Serum creatinine = 1.7 mg/ dl - 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. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion criteria Patients are excluded if they meet one of the following criteria: - Pregnant women, nursing mothers or a planned pregnancy within six months after last scheduled treatment - Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis. - Patients with fibromyalgia syndrome - Use of IM, IV, IA cortocisteroids within 4 weeks prior to screening. - Treatment with any investigational drug within 3 months prior to screening. - A history of known allergy to murine proteins, e.g. allergy to Infliximab - History of infected joint prothesis within the previous 5 years - Chronic infections - History of active tuberculosis requiring treatment within the previous 3 years, or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy if they will not be treated according to the local TB guidelines. - Current signs or symptoms of other severe uncontrolled disease which in the investigators opinion would put the patient at an unacceptable risk - History of lymphoproliferative disease, any current malignancies or history of malignancy within 5 years other than successfully treated basal cell carcinoma or squamous cell carcinoma of the skin - History of drug abuse - >75 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the efficacy of treatment in real life (routine clinical care) with Rituximab (MabThera®) in patients with active RA whose current treatment with a TNF-blocker (Etanercept - Enbrel®, Infliximab – Remicade® or Adalumimab - Humira®) in combination with MTX is insufficient. ;Secondary Objective: ;Primary end point(s): Primary outcome measure will be the frequency of reaching low disease activity or remission as measured by the ‘clinical disease activity index’ (CDAI) (1) (CDAI = 10). We estimate that 40 % of patients will reach low disease activity or remission. (1) Aletaha D, Nell VP, Stamm T, Uffmann M, Pflugbeil S, Machold K et al. Acute phase reactants add little to composite disease activity indices for rheumatoid arthritis: validation of a clinical activity score. Arthritis Res Ther 2005; 7(4):R796-R806. | — |
Countries
Austria
Outcome results
None listed