Trial Outcomes & Findings for An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis (NCT NCT01951170)
NCT ID: NCT01951170
Last Updated: 2016-09-21
Results Overview
The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
COMPLETED
PHASE3
52 participants
From baseline to Week 24
2016-09-21
Participant Flow
Participant milestones
| Measure |
Tocilizumab
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tocilizumab
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Overall Study
Investigator decision
|
1
|
Baseline Characteristics
An Open-Label Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Age, Continuous
|
56.87 years
STANDARD_DEVIATION 11.525 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 24Population: Full Analysis Set (FAS) included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number analyzed represents the number of participants for whom the Week 24 X-ray was performed.
The mTSS is a measure of joint damage that combines scores for bone erosion and joint-space narrowing (JNS). Erosion score: A total of 14 locations in each hand and wrist and 6 joints in the foot were evaluated for erosion using an 8-point scale where 0=normal to 3.5=very severe erosion. JNS score: A total of 13 locations in each hand and wrist and 6 joints in the foot were evaluated for joint narrowing score using a 9-point scale where 0=normal to 4.0=definite ankylosis (stiffness or fixation of a joint). mTSS scores ranged from 0 (normal) to 292 (worst possible total score). Change from baseline = mTSS score at Week 24 minus score at baseline. An increase in mTSS from baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.
Outcome measures
| Measure |
Tocilizumab
n=51 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Genant-modified Total Sharp Score (mTSS)
Baseline
|
7.00 units on a scale
Interval 0.0 to 95.8
|
|
Change From Baseline in Genant-modified Total Sharp Score (mTSS)
Change from baseline at Week 24
|
0 units on a scale
Interval -1.5 to 5.5
|
SECONDARY outcome
Timeframe: At Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count of 28 joints (TJC28), swollen joint count of 28 joints (SJC28), patient's global assessment of disease activity visual analog scale (PGA VAS) with 0=no disease activity to 100=maximum disease activity displayed on the 100-millimeter (mm) horizontal VAS and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to 10. Higher scores represent higher disease activity. DAS28-ESR remission is defined as a score \< 2.6.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Percentage of Participants With Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Remission
|
76.60 percentage of participants
Interval 61.97 to 87.7
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
A positive ACR20 response requires at least 20% improvement compared to baseline in SJC (66 joints) and TJC (68 joints) as well as at least 20% improvement in 3 of the following 5 assessments: 1) PGA pain VAS, 2) PGA VAS; 3) physician's global assessment of disease activity VAS, 4) Health Assessment Questionnaire-Disability Index (HAQ-DI) with 20 questions consisting of 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and activities, 0=without difficulty to 3=unable to do; and 5) acute phase reactant (C-reactive protein \[CRP\] - if not available, ESR was used). ACR50 and ACR70 responses are defined in a similar way except that they required a 50% and 70% improvement from baseline, respectively. VAS range for all assessments was 0=no disease activity to 100=maximum disease activity.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses
ACR20
|
91.49 percentage of participants
Interval 79.62 to 97.63
|
|
Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses
ACR50
|
76.60 percentage of participants
Interval 61.97 to 87.7
|
|
Percentage of Participants With Positive American College of Rheumatology 20/50/70 (ACR20/50/70) Responses
ACR70
|
53.19 percentage of participants
Interval 38.08 to 67.89
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
EULAR response was calculated as the difference between DAS28-ESR scores at baseline and Week 24, and reported as the percentage of participants with good, moderate, or no response. Good responders = decrease from baseline \>1.2 with a DAS28 score of ≤3.2; moderate responders = decrease from baseline \>1.2 with a DAS28 score of \>3.2, or decrease from baseline \>0.6 to ≤1.2 with a DAS28 score of ≤5.1; non-responders = decrease from baseline ≤0.6 or decrease from baseline \>0.6 and ≤1.2 with a DAS28 score of \>5.1.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response
No Response
|
2.13 percentage of participants
Interval 0.05 to 11.29
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response
Moderate
|
17.02 percentage of participants
Interval 7.65 to 30.81
|
|
Percentage of Participants With European League Against Rheumatism (EULAR) Response
Good
|
80.85 percentage of participants
Interval 66.74 to 90.85
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
PGA VAS is the participant's overall assessment of their current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as "maximum disease activity" (maximum arthritis disease activity). The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)
Baseline (n=52)
|
67.26 units on a scale
Standard Deviation 21.677
|
|
Change From Baseline in Patient's Global Assessment of Disease Activity Visual Analog Scale (PGA VAS)
Change from baseline at Week 24 (n=47)
|
-48.6 units on a scale
Standard Deviation 25.934
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
The PGA pain VAS is the participant's overall assessment of pain. Pain is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as "no pain" and the right-hand extreme (100 mm) is described as "unbearable pain". The change in PGA VAS is determined as the difference in values from baseline. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)
Baseline (n=52)
|
59.55 units on a scale
Standard Deviation 22.780
|
|
Change From Baseline in Patient's Global Assessment of Pain Using a Visual Analog Scale (PGA Pain VAS)
Change from baseline at Week 24 (n=47)
|
-41.9 units on a scale
Standard Deviation 26.980
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
The Physician Global Assessment of Disease Activity is the investigator's overall assessment of the participant's current disease activity. The disease activity is displayed on a 100-mm horizontal VAS. The left-hand extreme (0 mm) of the line is described as "no disease activity" (symptom free and no arthritis symptoms) and the right-hand extreme (100 mm) is described as "maximum disease activity" (maximum arthritis disease activity). The change in Physician Global Assessment of Disease Activity is determined as the difference in values from baseline. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Physician Global Assessment of Disease Activity
Baseline (n=51)
|
64.63 units on a scale
Standard Deviation 18.803
|
|
Change From Baseline in Physician Global Assessment of Disease Activity
Change from baseline at Week 24 (n=46)
|
-48.8 units on a scale
Standard Deviation 21.342
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
HAQ-DI is the participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Baseline (n=52)
|
1.36 units on a scale
Standard Deviation 0.639
|
|
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI)
Change from baseline at Week 24 (n=47)
|
-0.78 units on a scale
Standard Deviation 0.588
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
The FACIT measurement system is a collection of health-related quality of life questionnaires targeted to the management of chronic illness and includes questions on physical well-being, social/family well-being, emotional well-being and functional well-being. The FACIT-F Scale measures an individual's level of fatigue during their usual daily activities. Total scores range from 0 to 52 with lower scores representing greater fatigue, and scores below 30 representing severe fatigue. A positive change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Baseline (n=52)
|
27.42 units on a scale
Standard Deviation 11.771
|
|
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
Change from baseline at Week 24 (n=47)
|
12.62 units on a scale
Standard Deviation 10.541
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
The SDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as SDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) + C reactive protein (CRP) in milligrams/deciliter (mg/dL) with a total SDAI score ranging from 0 to 86. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 3.3; Low disease activity = score \> 3.3 and ≤ 11.0; Moderate disease activity = score \> 11.0 and ≤ 26.0; Severe disease = score \> 26.0. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Baseline (n=50)
|
38.65 units on a scale
Standard Deviation 14.656
|
|
Change From Baseline in Simplified Disease Activity Index (SDAI)
Change from baseline at Week 24 (n=45)
|
-31.6 units on a scale
Standard Deviation 16.470
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
The CDAI is a combined index for measuring disease activity in rheumatoid arthritis and calculated as CDAI = TJC28 + SJC28 + PGA VAS (in mm) + Physician Global Assessment of Disease Activity VAS (in mm) with a total CDAI score ranging from 0-76. Higher scores indicate greater disease activity. The SDAI scale is divided into the following categories: Clinical remission = score ≤ 2.8; Low disease activity = score \> 2.8 and ≤ 10.0; Moderate disease activity = score \> 10.0 and ≤ 22.0; Severe disease = score \> 22.0. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Baseline (n=51)
|
36.91 units on a scale
Standard Deviation 13.460
|
|
Change From Baseline in Clinical Disease Activity Index (CDAI)
Change from baseline at Week 24 (n=46)
|
-30.0 units on a scale
Standard Deviation 15.138
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
TJC was counted based on 68 joints (TJC68) and based on 28 joints (TJC28). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Total Tender Joint Count (TJC)
TJC68: Baseline (n=52)
|
24.27 tender joints
Standard Deviation 12.550
|
|
Change From Baseline in Total Tender Joint Count (TJC)
TJC68: Change from baseline at Week 24 (n=47)
|
-20.8 tender joints
Standard Deviation 13.622
|
|
Change From Baseline in Total Tender Joint Count (TJC)
TJC28: Baseline (n=52)
|
13.19 tender joints
Standard Deviation 6.234
|
|
Change From Baseline in Total Tender Joint Count (TJC)
TJC28: Change from Baseline at Week 24 (n=47)
|
-11.1 tender joints
Standard Deviation 7.568
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Participants with available data at the respective time points were analyzed.
SJC was counted based on 66 joints (SJC66) and based on 28 joints (SJC28). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Swollen Joint Count (SJC)
SJC66: Baseline (n=52)
|
17.00 swollen joints
Standard Deviation 11.068
|
|
Change From Baseline in Swollen Joint Count (SJC)
SJC66: Change from baseline at Week 24 (n=47)
|
-13.0 swollen joints
Standard Deviation 8.745
|
|
Change From Baseline in Swollen Joint Count (SJC)
SJC28: Baseline (n=52)
|
10.71 swollen joints
Standard Deviation 6.470
|
|
Change From Baseline in Swollen Joint Count (SJC)
SJC28: Change from baseline at Week 24 (n=47)
|
-8.77 swollen joints
Standard Deviation 5.994
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.
Bone erosions were assessed by magnetic resonance imaging (MRI) at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-10 on an 11-point scale with 0= no erosion, 1= 1-10% erosion, 2= 11-20% erosion, and up to 10= 91-100% erosion. Total score was the sum of the 25 individual scores and ranged 0-250 with 0= no erosion and 250= most severe erosion. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions
Baseline
|
8.88 units on a scale
Standard Deviation 6.70
|
|
Change From Baseline in Rheumatoid Arthritis Magnetic Resonance Imaging Scoring System (RAMRIS) Scoring of Bone Erosions
Change from baseline at Week 24
|
0.9 units on a scale
Standard Deviation 1.66
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.
Cartilage loss was assessed by MRI at baseline and Week 24. Scans of 25 joints were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-4 on a 9-point scale, with 0= no cartilage loss and 4= complete cartilage loss. Total score was the sum of the 25 individual scores and ranged 0-100 with 0= no cartilage loss and 100= most severe cartilage loss. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in RAMRIS Scoring of Cartilage Loss
Baseline
|
6.29 units on a scale
Standard Deviation 9.46
|
|
Change From Baseline in RAMRIS Scoring of Cartilage Loss
Change from baseline at Week 24
|
0.12 units on a scale
Standard Deviation 0.59
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.
Synovitis (synovial membrane inflammation) was assessed by MRI at baseline and Week 24. Scans of 8 joint locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no synovitis, 1= 1-33% volume enhancement, 2= 34-67% volume enhancement and 3= 68-100% volume enhancement. Total score was the sum of the 8 individual scores and ranged 0-24 with 0= no synovitis and 24= most severe synovitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in RAMRIS Scoring of Synovitis
Baseline
|
4.5 units on a scale
Standard Deviation 4.01
|
|
Change From Baseline in RAMRIS Scoring of Synovitis
Change from baseline at Week 24
|
-1.7 units on a scale
Standard Deviation 2.67
|
SECONDARY outcome
Timeframe: From baseline to Week 24Population: FAS included all enrolled participants who received at least one dose of subcutaneous tocilizumab. Here, the number of participants analyzed is the number for whom evaluable baseline and Week 24 images were available.
Osteitis (bone inflammation) was assessed by MRI at baseline and Week 24. Scans of 25 bone locations were read and scored in pairs for each participant by 2 assessors. Scores for each location ranged 0-3 on a 4-point scale, with 0= no osteitis, 1= 1-33% involvement of original articular bone, 2= 34-67% involvement of original articular bone and 3= 68-100% involvement of original articular bone. Total score was the sum of the 25 individual scores and ranged 0-75 with 0= no osteitis and 75= most severe osteitis. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Tocilizumab
n=50 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Change From Baseline in RAMRIS Scoring of Osteitis
Baseline
|
6.63 units on a scale
Standard Deviation 10.26
|
|
Change From Baseline in RAMRIS Scoring of Osteitis
Change from baseline at Week 24
|
-4 units on a scale
Standard Deviation 9.58
|
SECONDARY outcome
Timeframe: Up to Week 32 (end of follow up: 8 weeks after end of treatment)Population: The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Safety: Percentage of Participants With Adverse Events (AEs)
|
92.31 percentage of participants
|
SECONDARY outcome
Timeframe: Up to Week 32 (end of follow up: 8 weeks after end of treatment)Population: The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal
Leading to withdrawal of study treatment
|
2 adverse events
|
|
Safety: Number of AEs Leading to Tocilizumab Dose Modification or Study Treatment Withdrawal
Leading to dose modification
|
3 adverse events
|
SECONDARY outcome
Timeframe: At baseline, Week 32 (end of follow up: 8 weeks after end of treatment)Population: The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
A tocilizumab antibody screen was performed at baseline and at the end of follow up (8 weeks after end of treatment at Week 32). A confirmatory anti-tocilizumab antibody test was performed on positive screen samples. A confirmed positive test indicates the presence of tocilizumab antibodies.
Outcome measures
| Measure |
Tocilizumab
n=52 Participants
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks
|
|---|---|
|
Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity
Baseline
|
0 participants
|
|
Safety: Number of Participants With Confirmed Positive Assessment of Tocilizumab Immunogenicity
Week 32
|
0 participants
|
Adverse Events
Tocilizumab
Serious adverse events
| Measure |
Tocilizumab
n=52 participants at risk
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.9%
1/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
1.9%
1/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
1.9%
1/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
Other adverse events
| Measure |
Tocilizumab
n=52 participants at risk
Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.
Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
11.5%
6/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.6%
5/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Gastrointestinal disorders
Mouth ulceration
|
7.7%
4/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Gastrointestinal disorders
Nausea
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Infections and infestations
Upper respiratory tract infection
|
28.8%
15/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Injury, poisoning and procedural complications
Contusion
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Injury, poisoning and procedural complications
Laceration
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Investigations
Alanine aminotransferase increased
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Investigations
Transaminases increased
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
4/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
21.2%
11/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Nervous system disorders
Headache
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Nervous system disorders
Paraesthesia
|
7.7%
4/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
|
Vascular disorders
Hypertension
|
5.8%
3/52 • Up to Week 32 (end of follow up: 8 weeks after end of treatment)
The safety population included all enrolled participants who received at least one dose of subcutaneous tocilizumab.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER