A study to evaluate the efficacy and safety of tocilizumab subcutaneous in RA patients

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 17.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-002150-79-BE
• Lead Sponsor: .V. Roche S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-24
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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. Women of childbearing potential must use effective contraception during and up to 3 months following the last dose of TCZ.
8.If female of childbearing potential, the patient must have a negative pregnancy test at Screening and Baseline visits.
9.Patients who have either responded inadequately to, or who were intolerant to, previous therapy with two or more non-biologic DMARDs, one of which is MTX, administered in an optimal way during at least 3 months. Eligible patients may also be inadequate responders to a biologic DMARD therapy.
10.Have moderate to severe RA defined as DAS28 = 3.7.

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 37
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

General:
1.Major surgery (including joint surgery) within 8 weeks prior to Screening or planned major surgery within 6 months following Baseline or during LTE period.
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 syndrome). 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).
•Excluded Previous or Concomitant Therapy:
6.Exposure to 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 weeks prior to Baseline.
11.Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
12.Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.
•Exclusions for 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 disease such as Crohn’s disease, ulcerative colitis, or other symptomatic lower GI conditions 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. Patients should be screened for latent TB and, if positive, treated following local practice guidelines prior to initiating TCZ. Patients 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 or 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 carc

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified