Clinical trial NCT01254331: An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Official title: Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 51
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 open-label, multi-center study in a local environment will evaluate the safety and the effect on disease activity with regard to reduction in signs and symptoms over 6 months of treatment in patients with moderate to severe active rheumatoid arthritis who experienced an inadequate response to a non-biologic DMARD. Tocilizumab 8 mg/kg will be administered as an intravenous infusion every 4 weeks for a total of 6 infusions as monotherapy or in combination with methotrexate (MTX). The anticipated time of study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients \>/=18 years of age
* Moderate to severe rheumatoid arthritis defined as DAS 28\>3.2
* Body weight \</=150 kg
* Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any time prior to study start
* Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria:

* Major surgery within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
* Rheumatic autoimmune disease other than rheumatoid arthritis (RA)
* Functional class IV as defined by the ACR classification
* History or current inflammatory joint disease other than RA
* Previous treatment with any cell depleting therapy
* Previous treatment with methotrexate
* Previous treatment with tocilizumab
* Previous treatment with any biologic drug that is used in the treatment of RA

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
timeFrame: Baseline, every 4 weeks through Week 52
Secondary outcomes:
measure: Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Percentage of Participants Achieving LDA Assessed Using DAS28
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Percentage of Participants Achieving Remission Assessed Using DAS28
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Time To Achieve ACR20/ACR50/ACR70
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: SJC and TJC
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Assessment of Pain by the Participant Using Visual Analog Scale (VAS)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Assessment of Global Disease by the Participant Using VAS
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Mean C-Reactive Protein (CRP) Levels
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Mean Erythrocyte Sedimentation Rate (ESR) Levels
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
measure: Percentage of Participants Experiencing Fatigue
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Number of Participants Who Discontinued Tocilizumab
timeFrame: Week 52
Other outcomes:
Locations:
city: Sfax
country: Tunisia
city: Sousse
country: Tunisia
city: Tunis
country: Tunisia
city: Tunis
country: Tunisia
city: Tunis
country: Tunisia
city: Tunis
country: Tunisia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: