Rheumatoid arthritis MedDRA version: 9.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
Roche Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with active rheumatoid arthritis (DAS28 >=2.6) who participated in ML19070 (FIRST trial) and have completed the week 24 visit and who experienced a decrease (between week 16 and 24 in study ML19070) in DAS28 > 0.6 2.Eligible for re-treatment by the following criteria: Swollen joint count >=2 Tender joint count >=2 3. Not more than 1 year have passed since the patient’s first rituximab infusion within study ML19070 4. Not more than one TNF-alpha- inhibitor in history 5.Willingness and capability to give written informed consent, and willingness to participate and to comply with the study 6. Age range: 18 – 80 years at inclusion date in ML19070 7. Pregnancy urine test at screening (not earlier than 28 days prior to day 1) 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: General exclusion criteria 1. Patients from ML19070 having received any DMARD except MTX, any TNFalpha inhibitor, leflunomide or any anti-IL or CTLA4 Ig or any biological or investigational agent after the rituximab infusions 2. Patients with a response between week 16 and 24 in study ML19070 in DAS28 1.4 mg/dl for women or 1.6 mg/dl for men 26. AST or ALT > 2.5 times upper limit of nor-mal 27. Positive HIV or hepatitis C serology as well as positive tests for hepatitis B surface antigen (HBsAg) and/or positive tests for hepatitis B core antibody (anti-HBc-Ab) Exclusion criteria related to formal aspects 28. Previous (last 30 days) or current participation in another clinical trial with the exception of participation in study ML19070 29. Patients who have participated in this study before. 30. Patients who are underage or patients who are in¬capable to understand the aim, importance and consequences of the study and to give le-gal informed consent (according to § 40 Abs. 4 and § 41 A
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of Rituximab re-treatment according to different initial response rates;Secondary Objective: To demonstrate that re-treatment with Rituximab in rheumatoid arthritis is safe;Primary end point(s): Change of DAS28 achieved by first re-treatment at week 24 Change from course specific baseline and original course baseline | — |
Countries
Germany
Outcome results
None listed