Back to resultsAn Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Tunisia
Study Type
Interventional
Intervention
tocilizumab [RoActemra]
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single arm
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
Secondary Outcome Measures
Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)
DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.
Percentage of Participants Achieving LDA Assessed Using DAS28
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.
Percentage of Participants Achieving Remission Assessed Using DAS28
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.
Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.
Time To Achieve ACR20/ACR50/ACR70
The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.
SJC and TJC
28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.
Assessment of Pain by the Participant Using Visual Analog Scale (VAS)
The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to their level of pain and the distance from the left edge was measured.
Assessment of Global Disease by the Participant Using VAS
The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured.
Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured.
Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)
Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.
Mean C-Reactive Protein (CRP) Levels
CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).
Mean Erythrocyte Sedimentation Rate (ESR) Levels
ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.
Percentage of Participants Experiencing Fatigue
Number of Participants Who Discontinued Tocilizumab
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01254331
Brief Title
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
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
51 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
tocilizumab [RoActemra]
Intervention Description
tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Primary Outcome Measure Information:
Title
Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death
Time Frame
Baseline, every 4 weeks through Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28)
Description
DAS28 calculated from the swollen joint count (SJC) and tender joint count (TJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour [mm/hour]) and participant's global assessment (PtGA) of disease activity by Visual analog Scale (VAS; participant rated arthritis activity assessment) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 less than or equal to (≤) 3.2 equals (=) low disease activity (LDA), DAS28 greater than (>) 3.2 to 5.1 = moderate to high disease activity. A reduction of at least 1.2 units in DAS28 was considered clinically significant improvement.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Percentage of Participants Achieving LDA Assessed Using DAS28
Description
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. DAS28 less than (<) 3.2 = LDA.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Percentage of Participants Achieving Remission Assessed Using DAS28
Description
DAS28 calculated from the SJC and TJC using the 28 joints count, the ESR (mm/hour) and PtGA of disease activity (VAS) with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity. Participants were considered in remission when reaching a DAS28 score <2.6.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
Description
The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via a Health Assessment Questionnaire (HAQ), and 5) C-reactive protein (CRP) at each visit.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Time To Achieve ACR20/ACR50/ACR70
Description
The ACR response rates ACR20/ACR50/ACR70 are defined as ≥20%, ≥50%, or ≥70% improvement, respectively, in SJC and TJC, as well as a ≥20%, ≥50%, or ≥70% improvement, respectively, in 3 of the 5 remaining core ACR assessments: 1) physician's global assessment of disease activity, 2) participant's assessment of disease activity, 3) participant's assessment of pain, 4) participant's assessment of functional disability via (HAQ, and 5) CRP at each visit. The median time to achieve ACR20/ACR50/ACR70 was calculated using Kaplan-Meier estimates.
Time Frame
Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
SJC and TJC
Description
28 joints were assessed for swelling and tenderness. Joints were classified as swollen (1)/not swollen (0) and tender (1)/not tender (0) giving a total possible SJC and TJC score of 0 to 28 each.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Assessment of Pain by the Participant Using Visual Analog Scale (VAS)
Description
The participants assessed their pain using a 0 to 100 millimeter (mm) horizontal VAS. The left-hand extreme of the line equals 0 mm, and is described as "no pain" and the right-hand extreme equals 100 mm as "unbearable pain". The participants marked the line corresponding to their level of pain and the distance from the left edge was measured.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Assessment of Global Disease by the Participant Using VAS
Description
The participant's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the participant. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The participants marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS)
Description
The physician's global assessment of disease activity was assessed using a 0 to 100 mm horizontal VAS by the physician. The left-hand extreme of the line equals 0 mm, and is described as "no disease activity" (symptom-free and no arthritis symptoms) and the right-hand extreme equals 100 mm, as "maximum disease activity" (maximum arthritis disease activity). The physician marked the line corresponding to their assessment of disease activity and the distance from the left edge was measured.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Assessment of Physical Function Using Health Assessment Questionnaire (HAQ)
Description
Physical function was assessed using the HAQ. The HAQ scores range from 0 to 3 with, 0: no assistance needed, 1: participant uses a special device for day-to-day activities, 2: participant usually needs help from another person, and 3: participant uses BOTH a special device AND another person's help for day-to-day activities.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Mean C-Reactive Protein (CRP) Levels
Description
CRP is an acute phase reactant and levels of CRP increase with inflammation. CRP is measured as milligrams per liter (mg/L).
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Mean Erythrocyte Sedimentation Rate (ESR) Levels
Description
ESR is an acute phase reactant and levels of ESR increase with inflammation. ESR is measured as mm/hour.
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Title
Percentage of Participants Experiencing Fatigue
Time Frame
Baseline and Weeks 4, 8, 12, 16, 20, and 24
Title
Number of Participants Who Discontinued Tocilizumab
Time Frame
Week 52
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Sfax
ZIP/Postal Code
3000
Country
Tunisia
City
Sousse
ZIP/Postal Code
4000
Country
Tunisia
City
Tunis
ZIP/Postal Code
1007
Country
Tunisia
City
Tunis
ZIP/Postal Code
1008
Country
Tunisia
City
Tunis
ZIP/Postal Code
2010
Country
Tunisia
City
Tunis
ZIP/Postal Code
2046
Country
Tunisia
12. IPD Sharing Statement
Learn more about this trial
An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
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