Clinical trial NCT00773461: A Study of Tocilizumab in Combination With DMARD Therapy in Patients With Active Rheumatoid Arthritis.
Official title: A Randomized, Double Blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With DMARD Therapy, in Patients With Active Rheumatoid Arthritis and Inadequate Response to Current DMARD Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2008-10-16
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with DMARDs, in patients with active rheumatoid arthritis who currently have an inadequate response to DMARD therapy. Patients will be randomized 2:1 to receive tocilizumab 8mg/kg iv or placebo iv every 4 weeks, in conjunction with stable DMARD therapy. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, 18-70 years of age;
* rheumatoid arthritis for \>= 6 months;
* receiving permitted DMARDs, at a stable dose, for \>= 8 weeks prior to baseline;
* current inadequate clinical response to DMARDs.

Exclusion Criteria:

* major surgery, including joint surgery, within 8 weeks before entering study, or planned major surgery within 6 months following randomization;
* rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
* unsuccessful treatment with an anti-TNF agent;
* previous treatment with tocilizumab.

Primary outcomes:
measure: Percentage of Participants With an American College of Rheumatology (ACR)20 Response at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants With ACR50 and ACR70 Responses at Week 24
timeFrame: Week 24
measure: Number of Participants Who Received Escape Therapy
timeFrame: 24 Weeks
measure: Change in Tender and Swollen Joint Counts From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in Participant's Global Assessment of Disease Activity From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in Physician's Global Assessment of Disease Activity From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in Participant's Global Assessment of Pain From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in C-Reactive Protein From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Change in ESR From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Low Disease Activity and in Clinical Remission
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20 and 24
measure: Change From Baseline to Week 24 in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score
timeFrame: Baseline and Week 24
measure: Mean Rheumatoid Factor at Baseline and Week 24
timeFrame: Baseline and 24 Weeks
measure: Change in Hemoglobin From Baseline to Week 24
timeFrame: Baseline and 24 Weeks
measure: Change in Health Assessment Questionnaire - Disease Index (HAQ-DI) From Baseline to Week 24
timeFrame: Baseline and 24 Weeks
measure: Percentage of Participants With ACR20 Response by First Week of Onset
timeFrame: Weeks 2, 4, 8, 12, 16, 20, and 24
measure: Time to First Low Disease Activity
timeFrame: Weeks 2, 4, 8, 12, 16, 20, and 24
measure: Time to First Remission
timeFrame: Weeks 2, 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
city: Beijing
country: China
facility: Beijing Union Hospital
city: Beijing
country: China
facility: General Hospital of Chinese PLA; Department of Hematology
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-Sen University
city: Harbin
country: China
facility: The 1st Affiliated Hospital of Harbin Medical University
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
city: Shanghai
country: China
facility: Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
city: Shanghai
country: China
facility: Changhai Hospital of Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: