Clinical trial NCT01245439: A Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
Official title: Local Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs Who Have an Inadequate Response to Current Non-biologic DMARD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-11-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study will evaluate the safety, tolerability and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis (RA) on background non-biologic DMARDs who have an inadequate response to current non-biologic DMARDs. Patients will receive 8 mg/kg RoActemra/Actemra as an intravenous infusion every 24 weeks for a total of 6 infusions. The anticipated time on study treatment is 24 weeks.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Moderate to severe active rheumatoid arthritis (DAS28\>/=3.2) of \>/=6 months duration
* Body weight \</=150 kg
* Patients are on one or more non-biologic DMARDs at a stable dose for a period \>/=8 weeks prior to study treatment
* Patients with inadequate clinical response to a stable dose of non-biologic DMARD

Exclusion Criteria:

* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis, including systemic lupus erythematosus, mixed connective tissue disease, scleroderma, polymyositis, or significant systemic involvement secondary to rheumatoid arthritis
* History of or current inflammatory joint disease other than rheumatoid arthritis

Primary outcomes:
measure: Safety: Percentage of Participants With Treatment Emergent Adverse /Serious Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
measure: Percentage of Participants With All-Cause Discontinuation
timeFrame: 24 weeks
measure: Number of Participants With Alanine Transaminase (ALT) and Asapartate Transaminase (AST) Elevations of Greater Than (>) 1.5 Upper Limit of Normal (ULN), >3 ULN and > 5 ULN
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants With ALT and AST Elevations of >1.5 ULN, >3 ULN and > 5 ULN
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants With Serious Infections
timeFrame: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)
measure: Number of Participants With Serious Infections
timeFrame: Weeks 4 (Visit 3), 8 (Visit 4), and 16 (Visit 6)
measure: Change From Baseline to Highest Values for ALT and AST
timeFrame: Baseline to Week 24
measure: Change From Baseline to Highest Values for Low Density Lipoprotein (LDL) and Total Cholesterol
timeFrame: Baseline to Week 24
measure: Change From Baseline to Lowest Value for Absolute Neutrophil Count (ANC)
timeFrame: Baseline to Week 24
measure: Number of Participants With Elevations in Lipids According to Adult Treatment Panel (ATP) III Guidelines
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants With Elevations in Lipids According to ATP III Guidelines
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Number of Participants Who Achieved Clinically Meaningful Improvement in Disease Activity Score 28 (DAS28) At Every Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants Who Achieved Clinically Meaningful Improvement in DAS28 At Every Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Number of Participants Who Achieved LDA By Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants Who Achieved LDA By Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Time to LDA (DAS28 ) Based on First Visit When LDA Was Observed
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Number of Participants Who Achieved Remission (DAS28) By Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants Who Achieved Remission (DAS28) At Every Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants Achieving Their First Remission Status By Visit
timeFrame: Weeks 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Disease Activity Score as Measured By DAS28 at Each Visit
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Number of Participants Who Achieved American College of Rheumatology (ACR) 20, ACR 50, ACR 70 and ACR 90 Response
timeFrame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Percentage of Participants Who Achieved ACR 20, ACR 50, ACR 70 and ACR 90 Response
timeFrame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4),12 (Visit 5),16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: C-Reactive Protein Levels
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Erythrocyte Sedimentation Rate
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Mean Number of Tender and Swollen Joints
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Participant's (PT) and Investigator's (IN) Assessment of Disease Activity
timeFrame: Screening (Visit 1), Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Participant's Assessment of Pain
timeFrame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
measure: Health Assessment Questionnaire Score (General Score)
timeFrame: Weeks 0 (Visit 2), 4 (Visit 3), 8 (Visit 4), 12 (Visit 5), 16 (Visit 6), 20 (Visit 7) and 24 (Visit 8)
Other outcomes:
Locations:
city: Adana
country: Turkey
city: Ankara
country: Turkey
city: Ankara
country: Turkey
city: Aydin
country: Turkey
city: Bursa
country: Turkey
city: Denizli
country: Turkey
city: Elaziğ
country: Turkey
city: Gaziantep
country: Turkey
city: Istanbul
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Izmir
country: Turkey
city: Izmit
country: Turkey
city: Konya
country: Turkey
city: Manisa
country: Turkey
city: Samsun
country: Turkey
city: Sivas
country: Turkey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: