Clinical trial NCT01089023: A Study of Tocilizumab as Monotherapy or in Combination With DMARDs in Patients With Moderate to Severe Active Rheumatoid Arthritis
Official title: Multicenter, Open-Label Study to Evaluate the Safety, Tolerability and the Effect on Disease Activity of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD and/or Anti- TNF Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-18
Enrollment: 95
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 single-arm study will evaluate the safety, tolerability and efficacy of tocilizumab \[RoActemra/Actemra\] in patients with moderate to severe rheumatoid arthritis who experience an inadequate clinical response to a stable dose of non-biologic disease modifying anti-rheumatic drugs (DMARD) or anti-tumor necrosis factors (TNFs). RoActemra/Actemra will be administered as a monotherapy or in combination with DMARDs. RoActemra/Actemra will be administered as intravenous infusion at a dose of 8 mg/kg every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks. The target sample size is 50-150 patients.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/=18 years of age
* moderate to severe rheumatoid arthritis (DAS28 \>3.2) of 6 months duration
* inadequate clinical response to non-biologic DMARDs or anti-TNF
* bodyweight \</=150 kg

Exclusion Criteria:

* rheumatic autoimmune disease or inflammatory joint disease other than RA
* major surgery within 8 weeks prior to screening or planned major surgery within 6 months following screening

Primary outcomes:
measure: Percentage of Participants Reporting Any Adverse Event - Overall Summary of Events
timeFrame: Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24
Secondary outcomes:
measure: Percentage of Participants by Disease Activity Score Based on 28-Joint Count (DAS28) Category
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants Achieving a Clinically Meaningful Improvement as Measured by DAS28
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Time to DAS28 Response by DAS28 Category
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With a Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) of at Least 0.22 Units
timeFrame: Weeks 4, 8, 12, 16, 20, and 24
measure: Percentage of Participants With Improvement in Physical Function by HAQ-DI Category
timeFrame: Baseline, Weeks 4, 8, 12, 16, 20, and 24
measure: HAQ-DI Score by Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: C-Reactive Protein (CRP) Values by Study Visit
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
measure: Erythrocyte Sedimentation Rate
timeFrame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Other outcomes:
Locations:
city: Manama
country: Bahrain
city: Riffa
country: Bahrain
city: Isfahan
country: Iran, Islamic Republic of
city: Tehran
country: Iran, Islamic Republic of
city: Tehran
country: Iran, Islamic Republic of
city: Safat
country: Kuwait
city: Doha
country: Qatar
city: Abu Dhabi
country: United Arab Emirates
city: Abu Dhabi
country: United Arab Emirates
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: