PhaseⅢOpen-label Study of MRA for Rheumatoid Arthritis(RA)

Chugai Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: MRA(Tocilizumab)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380601

MRA225JP

Details and patient eligibility

About

An open-label, PhaseⅢ study to evaluate the efficacy and safety of MRA in patients with RA

Enrollment: 20 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism(ACR) in 1987
• Active RA despite at least one DMARDs or immunosuppressants or Infliximab or Etanercept.Active disease is defined as having at least 6 tender and 6 swollen joints among DAS28 (Modified Disease Activity Scores that include twenty eight joint counts) and ESR at least 30 mm/hr or CRP not less than 2.0mg/dL
• Active RA despite over 10mg adrenocortical steroids within 2 weeks before entry of this study

Exclusion criteria

• Shown to have class-Ⅳ Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug

• Treated with Infliximab within 3 months before and with Etanercept within 2 weeks before administration of the study drug

• Subjected to any of the following within 4 weeks before administration of the study drug:

  1. Surgical treatment (operations,etc.).
  2. Plasma exchange method

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

1

Experimental group

Treatment:

Drug: MRA(Tocilizumab)