Clinical trial NCT01258712: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Chugai Pharma Taiwan
Sponsor class: INDUSTRY
First posted: 2010-12-13
Enrollment: 86
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Proportion of patients with an American College of Rheumatology 20(ACR20) response
timeFrame: at baseline and week 24
Secondary outcomes:
measure: Proportion of patients with ACR50 response
timeFrame: at baseline and week 24
measure: Proportion of patients with ACR70 response
timeFrame: at baseline and week 24
measure: Mean change from baseline of Swollen joint count(SJC) and Tender joint count(TJC) respectively
timeFrame: at baseline and week 24
measure: Mean change from baseline in disease activity using 28-joint modified disease activity score (DAS28)
timeFrame: at baseline and week 24
measure: Proportion of patients achieving DAS28 remission (DAS28 < 2.6)
timeFrame: at week 24
measure: Adverse event incidence
timeFrame: from baseline to week 24
measure: Mean change from baseline to evaluation visits in vital signs
timeFrame: from baseline to week 24
measure: Result of Electrocardiogram. From baseline to evaluation visits
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative hematological exam results (including Hb, Ht, RBC, WBC & differential, platelet counts).
timeFrame: from baseline to week 24
measure: 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.).
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative serum lipid exam results.
timeFrame: from baseline to week 24
measure: Mean change from baseline visit to evaluation visits in quantitative urinalysis results.
timeFrame: from baseline to week 24
Other outcomes:
Locations:
city: Chiayi
country: Taiwan
facility: Buddhist Dalin Tzu Chi General Hospital
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital -Kaohsiung
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital - Linkou
Study officials:
affiliation: Chugai Pharma Taiwan
name: Yoshiaki Someya
role: STUDY_CHAIR
References: