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

Study Description

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Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Rheumatoid Arthritis (RA)	Drug: Tocilizumab + methotrexate(MTX); Drug: Tocilizumab placebo + methotrexate(MTX)	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients
Study Start Date :	December 2010
Actual Primary Completion Date :	October 2012
Actual Study Completion Date :	October 2012

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: Tocilizumab + methotrexate(MTX); Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
Placebo Comparator: 2	Drug: Tocilizumab placebo + methotrexate(MTX); Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

Outcome Measures

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Primary Outcome Measures :

1. Proportion of patients with an American College of Rheumatology 20(ACR20) response [ Time Frame: at baseline and week 24 ]

Secondary Outcome Measures :

1. Proportion of patients with ACR50 response [ Time Frame: at baseline and week 24 ]
2. Proportion of patients with ACR70 response [ Time Frame: at baseline and week 24 ]
3. Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively [ Time Frame: at baseline and week 24 ]
4. Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28) [ Time Frame: at baseline and week 24 ]
5. Proportion of patients achieving DAS28 remission (DAS28 < 2.6) [ Time Frame: at week 24 ]
6. Adverse event incidence [ Time Frame: from baseline to week 24 ]
7. Mean change from baseline to evaluation visits in vital signs [ Time Frame: from baseline to week 24 ]
8. Result of Electrocardiogram. From baseline to evaluation visits [ Time Frame: from baseline to week 24 ]
9. 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 ]
10. 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 ]
11. Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results. [ Time Frame: from baseline to week 24 ]
12. Mean change from baseline visit to evaluation visits in quantitative urinalysis results. [ Time Frame: from baseline to week 24 ]

Eligibility Criteria

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Ages Eligible for Study:	20 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Chugai Pharma Taiwan

Investigators

Study Chair:	Yoshiaki Someya	Chugai Pharma Taiwan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Chugai Pharma Taiwan
ClinicalTrials.gov Identifier:	NCT01258712 History of Changes
Other Study ID Numbers:	MRA230TW
First Posted:	December 13, 2010
Last Update Posted:	December 13, 2012
Last Verified:	December 2012

Additional relevant MeSH terms:

Arthritis; Arthritis, Rheumatoid; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Methotrexate; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents	Physiological Effects of Drugs; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Dermatologic Agents; Enzyme Inhibitors; Folic Acid Antagonists; Immunosuppressive Agents; Immunologic Factors; Antirheumatic Agents; Nucleic Acid Synthesis Inhibitors