Clinical trial NCT00848120: A Study to Assess the Effect of Tocilizumab on Signs and Symptoms in Patients With Rheumatoid Arthritis
Official title: An Open Label Study to Evaluate the Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-02-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single arm, open label study will assess the safety and efficacy, with regard to reduction of signs and symptoms,of treatment with tocilizumab in patients with moderate to severe active rheumatoid arthritis. Patients will receive tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions. Patients already receiving methotrexate at entry into the study may continue with their treatment together with tocilizumab.The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients,\>=18 years of age;
* rheumatoid arthritis diagnosed \>8 weeks and \<4 years prior to baseline;
* naive to, or not responding well to, methotrexate;
* swollen joint count \>=8 (66 joint count) and tender joint count\>=8 (68 joint count) at screening and baseline.

Exclusion Criteria:

* rheumatic autoimmune disease other than rheumatoid arthritis;
* patients with functional class IV rheumatoid arthritis;
* history of, or current, inflammatory joint disease other than rheumatoid arthritis, or other systemic autoimmune disorder.

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Percent (%) Improvement (ACR20 Response) at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving ACR 50% Improvement (ACR50 Response) at Week 24
timeFrame: Week 24
measure: Percentage of Participants Achieving ACR 70% Improvement (ACR70 Response) at Week 24
timeFrame: Week 24
measure: HAQ Disability Index (HAQ-DI) Score at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Score at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Disease Activity Score Based on 28 Joint Count - Erythrocyte Sedimentation Rate (DAS28-ESR) at Baseline and Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants With Disease Remission at Week 24 Assessed Using DAS28-ESR
timeFrame: Week 24
measure: Percentage of Participants With Low Disease Activity at Week 24 Assessed Using DAS28-ESR
timeFrame: Week 24
measure: Time to Onset of ACR20/50/70 Response
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
city: Manila
country: Philippines
facility: Manila Doctors Hospital; Rheumatology Section
city: Manila
country: Philippines
facility: Jose Reyes Memorial Medical Center
city: Muntinlupa
country: Philippines
facility: Alabang Medical Center
city: San Fernando
country: Philippines
facility: Our Lady of Mount Carmel Medical Center
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: