Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

NCT01258712 | Completed Phase 3

• 1 other identifier: MRA230TW
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 12

Brief Summary

This is a Phase III study to evaluate efficacy and safety of Tocilizumab in patients with Rheumatoid Arthritis.

Conditions

Rheumatoid Arthritis (RA)

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with an American College of Rheumatology 20(ACR20) response

  at baseline and week 24

Secondary Outcomes (12)

• Proportion of patients with ACR50 response

  at baseline and week 24

• Proportion of patients with ACR70 response

  at baseline and week 24

• Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively

  at baseline and week 24

• Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)

  at baseline and week 24

• Proportion of patients achieving DAS28 remission (DAS28 < 2.6)

  at week 24

Study Arms (2)

1

EXPERIMENTAL

Drug: Tocilizumab + methotrexate(MTX)

2

PLACEBO COMPARATOR

Drug: Tocilizumab placebo + methotrexate(MTX)

Interventions

Tocilizumab + methotrexate(MTX) DRUG

Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week

1

Tocilizumab placebo + methotrexate(MTX) DRUG

Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

2

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with history of moderate-to- severe rheumatoid arthritis for more than 6 months according to the American College of Rheumatology (ACR) 1987 revised criteria for the classification of RA.
• Patients who failed to achieve clinical response to treatment of at least 2 DMARDs(disease modifying anti-rheumatic drug) (including MTX) for at least 12 weeks within 12 months prior to screening, of which MTX must have been at a stable dose of 10-20 mg/wk for at least 12 weeks prior to screening. All other DMARDs should be given at standard therapeutic dose.
• Patients who satisfy swollen joint count (SJC) ≥ 6 (66 joint count) and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
• C-reactive protein (CRP) level ≥ 1 mg/dl or an erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour at screening and at baseline.

You may not qualify if:

• Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
• Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
• Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
• Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
• Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand \& foot fungal infections can participate.

Sponsors & Collaborators

• Chugai Pharma Taiwan: lead

Study Sites (12)

Buddhist Dalin Tzu Chi General Hospital

Chiayi City, Taiwan

Location

Chang Gung Memorial Hospital -Kaohsiung

Kaohsiung City, Taiwan

Location

Kaohsiung Medical University Hospital

Kaohsiung City, Taiwan

Location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Location

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Cheng Kung University Hospital

Tainan, Taiwan

Location

Cathay General Hospital

Taipei, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

Chang Gung Memorial Hospital - Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab; Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Yoshiaki Someya

  Chugai Pharma Taiwan

  STUDY CHAIR

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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 13, 2010
• Study Start: December 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 13, 2012

Record last verified: 2012-12

Locations

TW (12)