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

Primary Purpose

Rheumatoid Arthritis (RA)

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Tocilizumab + methotrexate(MTX)
Tocilizumab placebo + methotrexate(MTX)
Sponsored by
Chugai Pharma Taiwan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis (RA)

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Buddhist Dalin Tzu Chi General Hospital
  • Chang Gung Memorial Hospital -Kaohsiung
  • Kaohsiung Medical University Hospital
  • Kaohsiung Veterans General Hospital
  • Chung Shan Medical University Hospital
  • Taichung Veterans General Hospital
  • National Cheng Kung University Hospital
  • Cathay General Hospital
  • National Taiwan University Hospital
  • Taipei Veterans General Hospital
  • Tri-Service General Hospital
  • Chang Gung Memorial Hospital - Linkou

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Proportion of patients with ACR50 response
Proportion of patients with ACR70 response
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Adverse event incidence
Mean change from baseline to evaluation visits in vital signs
Result of Electrocardiogram. From baseline to evaluation visits
Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.

Full Information

First Posted
December 8, 2010
Last Updated
December 12, 2012
Sponsor
Chugai Pharma Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01258712
Brief Title
Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Official Title
Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chugai Pharma Taiwan

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis (RA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tocilizumab + methotrexate(MTX)
Intervention Description
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
Intervention Type
Drug
Intervention Name(s)
Tocilizumab placebo + methotrexate(MTX)
Intervention Description
Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week
Primary Outcome Measure Information:
Title
Proportion of patients with an American College of Rheumatology 20(ACR20) response
Time Frame
at baseline and week 24
Secondary Outcome Measure Information:
Title
Proportion of patients with ACR50 response
Time Frame
at baseline and week 24
Title
Proportion of patients with ACR70 response
Time Frame
at baseline and week 24
Title
Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
Time Frame
at baseline and week 24
Title
Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
Time Frame
at baseline and week 24
Title
Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
Time Frame
at week 24
Title
Adverse event incidence
Time Frame
from baseline to week 24
Title
Mean change from baseline to evaluation visits in vital signs
Time Frame
from baseline to week 24
Title
Result of Electrocardiogram. From baseline to evaluation visits
Time Frame
from baseline to week 24
Title
Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
Time Frame
from baseline to week 24
Title
Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, γ-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).
Time Frame
from baseline to week 24
Title
Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
Time Frame
from baseline to week 24
Title
Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
Time Frame
from baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshiaki Someya
Organizational Affiliation
Chugai Pharma Taiwan
Official's Role
Study Chair
Facility Information:
Facility Name
Buddhist Dalin Tzu Chi General Hospital
City
Chiayi
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital -Kaohsiung
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
Chung Shan Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
Cathay General Hospital
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital - Linkou
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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