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

Rheumatoid Arthritis (RA) Clinical Trial

Official title:

Randomized, Placebo-controlled Study of Tocilizumab in Combination With Methotrexate for Treatment of Moderate to Severe Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258712
• Other study ID #: MRA230TW
• Status: Completed
• Phase: Phase 3
• First received: December 8, 2010
• Last updated: December 12, 2012
• Start date: December 2010
• Est. completion date: October 2012

Study information

• Verified date: December 2012
• Source: Chugai Pharma Taiwan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Drug:
• Tocilizumab + methotrexate(MTX)
Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
• Tocilizumab placebo + methotrexate(MTX)
Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Chugai Pharma Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with an American College of Rheumatology 20(ACR20) response		at baseline and week 24	No
Secondary	Proportion of patients with ACR50 response		at baseline and week 24	No
Secondary	Proportion of patients with ACR70 response		at baseline and week 24	No
Secondary	Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively		at baseline and week 24	No
Secondary	Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)		at baseline and week 24	No
Secondary	Proportion of patients achieving DAS28 remission (DAS28 < 2.6)		at week 24	No
Secondary	Adverse event incidence		from baseline to week 24	Yes
Secondary	Mean change from baseline to evaluation visits in vital signs		from baseline to week 24	Yes
Secondary	Result of Electrocardiogram. From baseline to evaluation visits		from baseline to week 24	Yes
Secondary	Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).		from baseline to week 24	Yes
Secondary	Mean change from baseline visit to evaluation visits in quantitative Biochemical exam of blood results (including AST, ALT, Alk-p, ?-GTP, LDH, total protein, albumin, total bilirubin, BUN, uric acid, creatinine, glucose, ferritin, K, Na, Cl, Ca, P.).		from baseline to week 24	Yes
Secondary	Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.		from baseline to week 24	Yes
Secondary	Mean change from baseline visit to evaluation visits in quantitative urinalysis results.		from baseline to week 24	Yes