ot applicable

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 16.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-000359-42-GR
• Lead Sponsor: ROCHE HELLAS S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-27
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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 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. Females of childbearing potential must use a reliable means of contraception for at least 3 month following the last dose of TCZ.
8.If female of childbearing potential, the patient must have a negative pregnancy test at the Screening and Baseline visits.
9.The target population for this study is adult men or women with active Rheumatoid Arthritis ,DAS28(ESR) >3.2, early RA of less than 6 month duration or established RA of more than 6 month duration , either naïve to MTX and /or other non biologic DMARD’s treatment, or having inadequate response (inefficacy/intolerance) to previous non biologic DMARDs ( MTX-IR, DMARD-IR) and/or having inadequate response (inefficacy/ intolerance) to previous biologic DMARDs (including Tumor necrosis factor-TNFiIR or Abatacept- when this was assigned as first line biologic-Abatacept IR IR). Patients who have experienced inadequate responses (inefficacy/intolerance) to previous biologics DMARDs could participate in this study with or without going through a biologic wash-out period. The time between the last dose of TNF inhibitor or Abatacept and the inclusion in the study could be between 1 and 8 weeks depending on the approved dosing interval as reported in the SmPC and according to the physician’s judgment.

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

A patient will be excluded if the answer to any of the following statements is yes”.
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 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 (Appendix 2).
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).
6.Patients with lack of peripheral venous access.

Excluded Previous or Concomitant Therapy:
7.Exposure to TCZ (either IV or SC) at any time prior to Baseline.
8.Treatment with any investigational agent within 4 weeks (or five half-lives of the investigational drug, whichever is longer) of Screening.
9.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.
10.Treatment with IV gamma globulin, plasmapheresis within 6 months of Baseline.
11.Intraarticular (IA) or parenteral corticosteroids within 4 weeks prior to Baseline.
12.Immunization with a live/attenuated vaccine within 4 weeks prior to Baseline.
13.Any previous treatment with alkylating agents such as chlorambucil, or with total lymphoid irradiation.

Exclusions for General Safety:
14.History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
15.Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus), or GI disease.
16.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.
17.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).
18.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.
19.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.
20.Current liver disease as determined by the Investigator.
21.Positive hepatitis B surface antigen (HbsAg) or hepatitis C antibody.
22.Primary or secondary immunodeficiency (history of or currently active).
23.Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (i

Study & Design

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