Extension Phase of the Multi-National Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients with Active Rheumatoid Arthritis on Background Non-biologic Disease-Modifying Anti-Rheumatic Drugs (DMARDs) who have an Inadequate Response to Current Non-biologic DMARD and/or Anti Tumor necrosis factor (Anti-TNF) Therapy

Phase 3

Completed

• Conditions: Patients with severe to moderate rheumatoid arthritis; Inflammatory and Immune System - Rheumatoid arthritis

• Registration Number: ACTRN12609000747224
• Lead Sponsor: Roche Products Pty Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-08-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

1.Completed the 24-week MA21573 core study, had at least a moderate response (European League Against Rheumatism [EULAR] definition criteria) and no AEs, SAEs or conditions that lead to unacceptable risk of continued treatment. Patients should be scheduled to receive the first tocilizumab (TCZ) infusion in MA22460 between 4 and 16 weeks after the last iv infusion in the core study.
2.Willing to give written informed consent for participation in the extension study
3.Able and willing to comply with the requirements of the extension study protocol

Exclusion Criteria

Disease
1.Functional class IV as defined by the ACR Classification of Functional Status in RA (largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care)
If female and of child-bearing potential, the patient must have a negative urine pregnancy test at day 1
Laboratory analyses (at transition from core study)
2.Serum creatinine > 142 micromol/L (1.6 mg/dL) in female patients and > 168 micromol/L (1.9 mg/dL) in male patients and no active renal disease
3.ALT or AST > 3 ULN (If initial yield ALT or AST =3 ULN, a second sample may be taken and tested)
4.Platelet count < 100 x 109/L (100,000/mm3)
5.Hemoglobin < 85 g/L (8.5 g/dL; 5.3 mmol/L)
6.WBC < 1.0 x 109/L (1000/mm3), ANC < 1 x 109/L (1000/mm3)
7.Absolute lymphocyte count < 0.5 x 109/L (500/mm3)
8.Known positive hepatitis B surface antigen or hepatitis C antibody
9.Total bilirubin > ULN (If initial sample yields bilirubin > ULN, a second sample may be taken and tested)
10.Triglycerides > 10 mmol/L (> 900 mg/dL) at inclusion in extension study

General medical
11.Treatment with any investigational agent since the last administration of study drug in the MA21573 study
12.Previous treatment with any cell depleting therapies, including investigational agents (e.g. CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19 and anti-CD20) since the last administration of study drug in the MA21573 study
13.Treatment with iv gamma globulin, plasmapheresis or Prosorba (trademark) column since the last administration of study drug in the MA21573 study
14.Treatment with an anti-TNF or anti-IL1 agent, or a T-cell co-stimulation modulator or any biologic or participation in any research study since the last administration of study drug in the MA21573 study
15.Parenteral, intramuscular or intra-articular corticosteroids within 6 weeks since the last administration of study drug in the MA21573 study
16.Immunization with a live/attenuated vaccine since the last administration of study drug in the MA21573 study
17.Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation since the last administration of study drug in the MA21573 study
18.Females of child-bearing potential who are not using a reliable means of contraception, e.g. physical barrier (patient and partner), contraceptive pill or patch, spermicide and barrier, or intrauterine device (IUD)
19.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease
20.Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
21.Current liver disease as determined by the investigator. Patients with prior history of ALT elevation are not excluded
22.Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, 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 or oral antibiotics
23.History of or currently active primary or secondary immunodeficiency
24.Evidence of active malignant disease,

Study & Design

• Study Type: Interventional
• Study Design: Not specified