An Extension Study of Tocilizumab (Myeloma Receptor Antibody [MRA]) in Patients Completing Treatment in Tocilizumab Core Studies

Not Applicable

• Conditions: -M069; M069

• Registration Number: PER-082-06
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-10-20
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 34

Inclusion Criteria

1) To have completed the treatment specified in the central studies and to receive the first scheduled infusion of tocilizumab (MRA) of the WA18696 between 4 and 12 weeks after the last IV infusion of the central studies.
2) Appointed and willing to give written informed consent and to comply with the requirements of the study protocol.
3) MTX or other DMARDs will be allowed if they are maintained in a dose and stable route of administration since the last study drug administration in the central studies.
4) Oral corticosteroids and NSAIDs are allowed if the dose is stable since the last administration of the central studies drug.
5) If patients are taking MTX, they should agree to receive oral folate.
6) Women with potential fertility and men with women couples with potential fertility can participate in this study only if they use a reliable contraceptive method.
7) If it is a woman with potential fertility, the patient must have a negative urine pregnancy test at the beginning.

Exclusion Criteria

1) A treatment with any agent under investigation since the last administration of the central studies drug.
2) Previous treatment with any cell depletion therapy, including agents under investigation.
3) Treatment with intravenous gammaglobulin, plasmapheresis or Prosorba ™ column since the last administration of the central studies drug.
4) Treatment with an anti-TNF or anti-IL-1 agent, or a costimulation modulator of T cells or any biological or participate in any research study since the last administration of the central studies drug.
5) Intramuscular or intraarticular parenteral corticosteroids, in the six weeks prior to the start of WA18696.
6) Immunization with a live / attenuated vaccine since the last drug administration of the central studies.
7) Any previous treatment with alkylating agents.
8) History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.
9) Evidence of serious concomitant and uncontrolled cardiovascular, neurological, pulmonary, renal, hepatic, endocrine, immunological or gastrointestinal disease.
10) Bacterial, viral, fungal, mycobacterial or other known infections, active or with a history of recurrences, or any serious episode of infection that requires hospitalization or treatment with IV antibiotics within four weeks prior to initiation or oral antibiotics within two weeks before the initiation.
11) Evidence of active malignancy.
12) Patients whose AST or ALT values ​​≥ 3 times ULN, bilirubin> 2 times ULN or> 2.5 mg / dL.

Study & Design

• Study Type: Interventional
• Study Design: Not specified