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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
51
tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
Unnamed facility
Sfax, Tunisia
Unnamed facility
Sousse, Tunisia
Unnamed facility
Tunis, Tunisia
Unnamed facility
Tunis, Tunisia
Unnamed facility
Tunis, Tunisia
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
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.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Tunis, Tunisia
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
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.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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).
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
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.
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52
Percentage of Participants Experiencing Fatigue
Time frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24
Number of Participants Who Discontinued Tocilizumab
Time frame: Week 52