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

NCT00144508 | Completed Phase 3

• 1 other identifier: MRA012JP
• Study Type: interventional
• Target: 306
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Change in the erosion score, as determined by the modified Sharp method.

  week 52

• Frequency and severity of adverse events and adverse drug reactions

  throughout study

Secondary Outcomes (2)

• Change in the erosion score

  week 28

• Changes in the joint space narrowing score and total Sharp score

  week 28, 52

Study Arms (2)

1

EXPERIMENTAL

Drug: MRA (Tocilizumab)

2

OTHER

continue current treatment

Other: current treatment

Interventions

MRA (Tocilizumab) DRUG

8mg /kg /4week for 52 weeks

1

current treatment OTHER

continue current treatment

2

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.).

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 5, 2005
• Study Start: March 1, 2003
• Primary Completion: May 1, 2004
• Study Completion: February 1, 2006
• Last Updated: February 2, 2009

Record last verified: 2009-01