Re-Treatment with Rituximab in patients with rheumatoid arthritis who have had an inadequate response to not more than one aTNF (extension study to ML19070) - Efficacy of re-therapy in anti-TNFalpha IR
- Conditions
- Rheumatoid arthritisMedDRA version: 9.1Level: PTClassification code 10039073Term: Rheumatoid arthritis
- Registration Number
- EUCTR2006-006746-33-DE
- Lead Sponsor
- Roche Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
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
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 <=0.6 to rituximab. These Patients will remain in study ML19070 until completion or withdrawal.
Exclusion criteria related to RA
3. Functional class IV
Exclusion criteria related to general health
4. Patients with other chronic inflammatory articular disease or systemic autoimmune disease
5. Any active infection, a history of recurrent clinically significant infection, a history of recurrent bacterial infections with encapsulated organisms
6. Primary or secondary immunodeficiency
7. History of cancer with curative treatment not longer than 5 years ago except basal-cell carcinoma of the skin that had been excised
8. Evidence of significant uncontrolled concomitant diseases or serious and/or uncon-trolled diseases that are likely to interfere with the evaluation of the patient's safety and of the study outcome
9. Neuropathy that can interfere with filling out the patient's questionnaires
10. History of a severe psychological illness or condition
11. Known hypersensitivity to any component of the product or to murine proteins
12. Women lactating, pregnant or of childbearing po¬tential and males of reproductive potential not using a highly effective contraceptive method (i.e. with a failure rate of less than 1% per year, are implants, injectables, com-bined oral contraceptives, IUDs (only hor-mon¬spirals), sexual abstinence or vasecto¬mi¬zed partner. Women of childbearing potential must have a negative pregnancy test (urine) at screening and must confirm in a written form at day 1, day x2, and day x3 that they are not pregnant if the pregnancy test is not repeated.
13. History of alcohol, drug or chemical abuse
14. Lack of peripheral venous access
Exclusion criteria related to medications
15. Intolerance to rituximab
16. Previous treatment with abatacept
17. Treatment with corticosteroids exceeding 10 mg per day prednisone or equivalent 2 weeks prior to day 1
18. Patients who have developed known contraindications to high dose corticosteroids (e.g. poorly controlled hypertension or diabetes mellitus, history of psychological events to steroids).
19. Intolerance or contraindication to drugs required for the treatment of the side effects of rituximab
20. Receipt of a live vaccine within 4 weeks prior to treatment
21. Intra- articular or parenteral corticosteroids within 4 weeks prior to treatment
Exclusion criteria related to lab findings
22. Haemoglobin < 8.5 g/dl
23. Neutrophil counts < 1.500/µl
24. Platelet count < 75.000/µl
25. Serum creatinine > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method