Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)

Chugai Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Other: current treatment

Drug: MRA (Tocilizumab)

Study type

Interventional

Funder types

Industry

Identifiers

MRA012JP

Details and patient eligibility

About

To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

Enrollment

306 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL.

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 drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).