ong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in MRA core studies.
- Conditions
- Rheumatoid arthritis
- Registration Number
- EUCTR2005-002909-23-LT
- Lead Sponsor
- F Hoffmann La-Roche Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2420
1) Completion of treatment as specified in the core studies, and scheduled to receive the first tocilizumab (MRA) infusion in WA18696 between 4 and 12 weeks after the last iv infusion in the core studies. Patients that are prevented from enrollment prior to12 weeks after the last infusion in the core studies due to administrative delays outside the control of the investigator and upon discussion with Roche may be included if they meet all other inclusion criteria, but will undergo a separate analysis of the study results.
2) Able and willing to give written informed consent and comply with the requirements of the study protocol.
3) Have received MTX or other allowable DMARD at a stable dose and route of administration since the last administration of study drug in the core studies. Patients enrolled from study WA17824, will receive tocilizumab (MRA) 8 mg/kg monotherapy or combination therapy at the discretion of the investigator.
4) Oral corticosteroids (=10 mg/day prednisone or equivalent) and NSAIDS (up to the maximum recommended dose) are permitted if dose stable since the last administration of study drug in the core studies.
5) If taking MTX, must be willing to receive oral folate (at least 5 mg/week).
6) Females of child-bearing potential and males with female partners of child-bearing potential may participate in this trial only if using a reliable means of contraception (e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or IUD).
7) If female and of child-bearing potential, the patient must have a negative urine pregnancy test at baseline.
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
1) Treatment with any investigational agent since the last administration of study drug in the core studies.
2) Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20)
3) Treatment with iv gamma globulin, plasmapheresis or Prosorba™ column since the last administration of study drug in the core studies.
4) Treatment with an anti-TNF or anti-IL1 agent, or a T-cell costimulation modulator or any biologic or participation in any research study since the last administration of study drug in the core studies.
5) Parenteral, intramuscular or intra-articular corticosteroids within 6 weeks prior to baseline in WA18696.
6) Immunization with a live/attenuated vaccine since the last administration of study drug in the core studies.
7) Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.
8) History of severe allergic or anaphylactic reaction to human, humanized or murine monoclonal antibodies.
9) Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (incl. obstructive pulmonary disease), renal, hepatic, endocrine (incl. uncontrolled diabetes mellitus), immunologic or gastrointestinal disease; history of diverticulosis requiring antibiotic treatment or chronic ulcerative lower GI disease such as Crohn's disease, ulcerative colitis or other symptomatic lower GI conditions that might predispone to perforations for whom a favourable benefit/risk assessment for study continuation cannot be documented.
10) Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, clinically significant abnormalities on chest X-ray as determined by the investigator, HIV, hepatitis B and C, and Herpes zoster, but excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization or treatment with iv antibiotics within four weeks prior to baseline or oral antibiotics within two weeks prior to baseline.
11)Evidence of active malignant disease, including solid tumors and hematologic malignancies diagnosed within the previous 10 years (except basal cell carcinoma of the skin that has been excised and cured), breast cancer diagnosed within the previous 20 years.
12) Patients whose AST or ALT = 3 times ULN, bilirubin > 2 times ULN and > 2.5 mg/dL (43 umol/L), neutrophils < 1000/cubic millimetre (1 x 10 to the power 3/uL or 1 GI/L), or who have an infection.
13. Serum creatinine > 123.8 umol/L (1.4 mg/dL ) in female patients and > 141.4 umol/L (1.6 mg/dL) in male patients
14. Platelet count < 100 x 10 to the power 9/L (100,000/cubic millimetre)
15. Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
16. White Blood Cells < 3 x 109/L (3000/cubic millimetre)
17. Absolute Neutrophil Count < 2 x 109/L (2000/cubic millimetre)
18. Absolute Lymphocyte Count < 0.5 x 109/L (500/cubic millimetre)
19. Positive Hepatitis BsAg, or Hepatitis C antibody
20. Total Bilirubin > ULN. (If initial sample yields Bilirubin > ULN, a second sample may be taken and tested during the screening period.)
21. Triglycerides > 10 mmol/L (> 900 mg/dL) at screening (non-fasted)
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