ong-term extension study of safety during treatment with tocilizumab (MRA) in patients completing treatment in WA17822

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 630

Inclusion Criteria

1) Completion of 24 weeks of treatment with tocilizumab (MRA) in WA17822, and scheduled to receive the first tocilizumab (MRA) infusion in WA18695 between 4 and 12 weeks after the last iv infusion in WA17822.
2) Able and willing to give written informed consent and comply with the requirements of the study protocol.
3) Have received methotrexate at a stable dose of between 10 and 25 mg/week (p.o. or parenteral) since the last administration of study drug in WA17822.
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 WA17822.
5) Must be willing to receive oral folate (at least 5 mg/week).
6) Females of child-bearing potential and males with female partners of childbearing
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

Exclusion Criteria

Patients with history of inflammatory lower GI disease, such as diverticulitis, colitis, enteritis, as well as symptomatic diverticulosis (with or without history of bleeding) are excluded.

Patients already randomized in the study will be re-evaluated for history of lower GI disease at the next scheduled study visit and their risk/benefit assessed to determine if they may continue in the study (details given in Section 7.3.1). If agreed to continue in the study, patients with history of lower GI disease will be required to sign an addendum to the informed consent indicating their willingness to remain in the study and undergo the additional tests required. Patients who have a negative outcome to the risk/benefit assessment or who are not willing to undergo the additional tests will be withdrawn.

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

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