Safety and efficacy study of tocilizumab injected under the skin in patients with active rheumatoid arthritis (RA) and inadequate response to disease modifying antirheumatic drugs.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 137

Inclusion Criteria

Patients must meet the following criteria for study entry:
1. Able and willing to give written informed consent and comply with the requirements of the study protocol
2. Patients at least 18 years of age.
3. Patients with a diagnosis of active RA according to the revised (1987) ACR criteria or EULAR/ACR (2010) criteria
4. Oral corticosteroids (=10 mg/day prednisone or equivalent) and nonsteroidal anti inflammatory drugs (NSAIDs; up to the maximum recommended dose) are permitted if on a stable dose regimen for =4 weeks prior to Baseline.
5. Permitted non-biologic DMARDs are allowed if at a stable dose for at least 4 weeks prior to Baseline.
6. Receiving treatment on an outpatient basis, not including TCZ.
7. Females of childbearing potential and males with female partners of childbearing potential may participate in this study only if using a reliable means of contraception (e.g. physical barrier [patient or partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device) during the study and for a least 5 months following the last dose ot TCZ
8. If female of childbearing potential, the patient must have a negative pregnancy test at Screening and Baseline visits.
9. Patient with inadequate response and/or intolerance to MTX or other non-biologic DMARDs and/or where MTX or other non-biologic DMARDs are inappropriate
10. Have moderate to severe RA, DAS-28-ESR>3.2
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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

General

1. Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline
2.Rheumatic autoimmune disease other than RA, including systemic lupus erythematosis, mixed connective tissue disorder, scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g vasculitis, pulmonary fibrosis or Felty´s syndorme). Secondary Sjögren´s syndrome with RA is permitted.
3. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
4. Diagnosis of juvenile idiopathic arthritis or juvenile RA and/or RA before the age of 16.
5. Prior history of or current inflammatory joint disease other than RA (e.g. gout, Lyme disease, seronegative spondyloarthropathy including reactive arthritis, psoriatic arthritis, and arthropathy of inflammatory bowel disease

Previous or Concomitant Therapy
6. Exposure to any biologic DMARDs, including TCZ (either intravenous [IV] or SC) at any time prior to Baseline.
7. Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
8.Previous treatment with any cell-depleting therapies, including investigational agents or approved therapies, some examples are CAMPATH, anti-CD4. anti-CD5, anti-CD3, anti-CD19 and anti-CD20.
9. Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline
10. Intraarticular or parenteral corticosteroids within 4 weeds prior to Baseline
11. Immunization with a live/attenuated vaccine 4 weeks prior to Baseline
12. Any previous treatment with alkylating agents such as chlorambucil or with total lymphoid irradation

General Safety
13. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
14. Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or gastrointestinal (GI) disease.
15. History of diverticulitis, diverticulosis requiring antibiotic treatment, or chronic ulcerative lower GI diseases such as Crohn’s disease, ulcerative colitis or other symptomatic lower GI condition that might predispose to perforation
16. Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections (including but not limited to tuberculosis [TB] and atypical mycobacterial disease, hepatitis B and C, and herpes zoster, but excluding fungal infections of nail beds).
17. Any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of Screening or oral antibiotics within 2 weeks of Screening,
18. Active TB requiring treatment within the previous 3 years. Patient should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patient treated for TB with no recurrence in 3 years are permitted.
19. Current liver disease as determined by the Investigator
20. Positive hepatitis B surface antigen or hepatitis C antibody.
21. Primary and secondary immunodeficiency (history of or currently active)
22. Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (including hematological malignancies and solid tumors, except basal and squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that has been excised and cured),

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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