Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

NCT00144521 | Completed Phase 3

• 1 other identifier: MRA213JP
• Study Type: interventional
• Target: 127
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Frequency of ACR 20% improvement

  week 24

Secondary Outcomes (3)

• Frequency and severity of adverse events and adverse drug reactions

  throughout study

• Time course of DAS28

  throughout study

• time course of the frequency of ACR 20%, 50% and 70%

  throughout study

Study Arms (2)

1

EXPERIMENTAL

Drug: MRA(Tocilizumab); Drug: MTX placebo

2

ACTIVE COMPARATOR

Drug: MRA placebo; Drug: MTX

Interventions

MRA(Tocilizumab) DRUG

8mg/kg/4week(i.v.)for 24 weeks

1

MRA placebo DRUG

0mg/kg/4week(i.v.) for 24 weeks

2

MTX DRUG

8mg/week(p.o.) for 24 weeks

2

MTX placebo DRUG

0mg/week(p.o.) for 24 weeks

1

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
• Disease duration of 6 months or more
• Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
• Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which 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 1.0 mg/dL

You may not qualify if:

• Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
• Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug
• Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.
• Administration of any DMARD or immunosuppressant other than MTX
• Administration of corticosteroids exceeding 10 mg/day as prednisolone
• Dose escalation or initiation of corticosteroids
• Received any of the following therapies in the 4 weeks preceding treatment with the study drug
• Plasma exchange therapy
• Surgical treatment (operation, etc.)

Sponsors & Collaborators

• Chugai Pharmaceutical: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Takahiro Kakehi

  Chugai Pharmaceutical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: February 1, 2004
• Primary Completion: August 1, 2004
• Study Completion: April 1, 2006
• Last Updated: February 2, 2009

Record last verified: 2009-01