Rheumatoid arthritis MedDRA version: 14.1 Level: LLT Classification code 10003268 Term: Arthritis rheumatoid System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Injection
INN or Proposed INN: RITUXIMAB
CAS Number: 174722-31-7
Current Sponsor code: NA
Other descriptive name: NA
Concentration unit: mg
Sponsors
A.O. UNIVERSITARIA INTEGRATA DI VERONA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients affected by rheumatoid arthritis, diagnosed in agreement with the American College of Rheumatology 1987 criteria, who had been previously treated with rituximab at the usual dose of 1000 mg, two infusions two weeks apart, for at least two cycles, obtaining a good clinical response (reduction of at least 1.2 points of Disease Activity Score DAS28, as observed at the last visit, in comparison with the basal value, before the rituximab treatment start). The patients had previously failed, for inefficacy or intolerance, therapy with either methotrexate and TNF blockers. Age of the patients > 18 years. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 14
Exclusion criteria
Exclusion criteria: - Hypersensitivity to the drug or to murine proteins or to any component of the product - severe, active infections - severe heart failure (New York Heart Association class IV) or severe uncontrolled heart disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the present study is to evaluate if rituximab at the dose of 500 mg e.v., two infusions two weeks apart, is as effective as rituximab at the usual dose of 1000 mg, two infusions two weeks apart, in patients affected by rheumatoid arthritis who have been previously treated with rituximab at the standard dose for at least two cycles obtaining a good clinical response;Secondary Objective: -Evaluation of the number of tender joints -Evaluation of the number of swollen joints -Evaluation of the ESR and C-reactive protein -Evaluation of the number of patients in clinical remission (DAS28 < 2.6) -Evaluation of the progression of the anatomic damage by hand and feet X-ray examination -Evaluation of the adverse reactions -Evaluation of the number of B-lymphocytes -Detection of anti-rituximab antibodies -rituximab serum concentration -evaluation of hematosis, kidney and liver function -evaluation of the difference regarding DAS28 at the entry to the study and at the subsequent clinical evaluations until the end of the study;Primary end point(s): Difference regarding DAS28 at the entry to the study and at the end (T14 – 27 months after the entry) between group A (rituximab 500 mg) and group B (rituximab 1000 mg);Timepoint(s) of evaluation of this end point: baseline and T14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -number of tender joints -number of swollen joints -concentration of PCR -ESR -number of patients in clinical remission (DAS28 < 2.6) -progression of the anatomic damage by hand and feet X-ray examination -Incidence of adverse reactions -number of B-lymphocytes -Presence of anti-rituximab antibodies -rituximab serum concentration -concentration of hematochemical factors -concentration of kidney and liver related factor -difference regarding DAS28 at the entry to the study and at the subsequent clinical evaluations until the end of the study;Timepoint(s) of evaluation of this end point: baseline, T2, T3, T5, T6, T8, T9, T11, T12, T14 | — |
Countries
Italy
Contacts
Public ContactUnita' Operativa di Reumatologia
AOUI Verona
Outcome results
None listed