Trial Outcomes & Findings for Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis (NCT NCT00691028)
NCT ID: NCT00691028
Last Updated: 2026-01-07
Results Overview
The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient's assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient's global assessment of disease activity (VAS 0-100); c. Physician's global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
327 participants
Primary outcome timeframe
baseline and week 54
Results posted on
2026-01-07
Participant Flow
Participant milestones
| Measure |
TA-650 3 mg/kg
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
Open-label
327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
|
|---|---|---|---|---|
|
Open-label Period
STARTED
|
0
|
0
|
0
|
327
|
|
Open-label Period
COMPLETED
|
0
|
0
|
0
|
307
|
|
Open-label Period
NOT COMPLETED
|
0
|
0
|
0
|
20
|
|
Double-blind Period
STARTED
|
99
|
104
|
104
|
0
|
|
Double-blind Period
COMPLETED
|
86
|
91
|
95
|
0
|
|
Double-blind Period
NOT COMPLETED
|
13
|
13
|
9
|
0
|
Reasons for withdrawal
| Measure |
TA-650 3 mg/kg
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
Open-label
327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
|
|---|---|---|---|---|
|
Open-label Period
Adverse Event
|
0
|
0
|
0
|
16
|
|
Open-label Period
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
|
Open-label Period
not come to a hospital
|
0
|
0
|
0
|
1
|
|
Double-blind Period
Adverse Event
|
8
|
9
|
6
|
0
|
|
Double-blind Period
Lack of Efficacy
|
4
|
3
|
2
|
0
|
|
Double-blind Period
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
|
Double-blind Period
not come to a hospital.
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Increased Dose of TA-650(Infliximab) in Patients With Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
Total
n=307 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=95 Participants
|
0 Participants
n=61 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
89 Participants
n=37 Participants
|
96 Participants
n=56 Participants
|
92 Participants
n=95 Participants
|
277 Participants
n=61 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=37 Participants
|
8 Participants
n=56 Participants
|
12 Participants
n=95 Participants
|
30 Participants
n=61 Participants
|
|
Age, Continuous
|
49.7 years
STANDARD_DEVIATION 11.7 • n=37 Participants
|
48.8 years
STANDARD_DEVIATION 11.8 • n=56 Participants
|
50.4 years
STANDARD_DEVIATION 12.5 • n=95 Participants
|
49.6 years
STANDARD_DEVIATION 12.0 • n=61 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=37 Participants
|
86 Participants
n=56 Participants
|
89 Participants
n=95 Participants
|
253 Participants
n=61 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=37 Participants
|
18 Participants
n=56 Participants
|
15 Participants
n=95 Participants
|
54 Participants
n=61 Participants
|
PRIMARY outcome
Timeframe: baseline and week 54The ACR-N index of improvement is the minimum of the following: (1) the percent decrease from baseline in tender joint counts(TJC) or (2) the percent decrease from baseline in swollen joint counts(SJC) or (3) the median percent decrease from baseline for the following: a. Patient's assessment of pain (visual analog scale (VAS) 0-100, 100 worst pain); b. Patient's global assessment of disease activity (VAS 0-100); c. Physician's global assessment of disease activity (VAS 0-100); d. Physical function as measured by the Health Assessment Questionnaire(HAQ)(0-3); e. C-Reactive Protein(CRP) measurement. Higher numbers (maximum:100) indicate more improvement.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Numeric Index of American College of Rheumatology Response (ACR-N, N Shows the Percent Improvement)
|
51.3 percent change
Standard Deviation 32.1
|
53.8 percent change
Standard Deviation 34.4
|
58.3 percent change
Standard Deviation 31.3
|
SECONDARY outcome
Timeframe: 54 weeksACR 20 (50 or 70) response is a decrease of at least 20% (50% or 70%) in both TJC and SJC and in 3 to 5 assessments (patient's assessment of pain \[VAS\] with 0, no pain to 100, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity \[0, very well to 100, very poor and 0, no arthritis activity to 100, extremely active, respectively\]; \[HAQ\]: 20-questions on life activities \[0, no difficulty to 3, inability to perform a task\]; \[CRP\])
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)
ACR20% improvement(percentage)
|
75.8 percentage of participants
|
78.8 percentage of participants
|
82.7 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)
ACR50% improvement (percentage)
|
60.6 percentage of participants
|
58.7 percentage of participants
|
66.3 percentage of participants
|
|
Percentage of Participants Achieving American College of Rheumatology 20, 50 and 70% Response (ACR20, 50, 70)
ACR70% improvement (percentage)
|
37.4 percentage of participants
|
42.3 percentage of participants
|
43.3 percentage of participants
|
SECONDARY outcome
Timeframe: 54 weeksThe TJC was determined by examining 68 joints and identified the joints that were painful under pressure or to passive motion. The TJC was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Tender Joint Counts (TJC)
Tender joint count, baseline
|
18.6 count
Standard Deviation 11.3
|
18.0 count
Standard Deviation 10.5
|
17.5 count
Standard Deviation 10.9
|
|
Tender Joint Counts (TJC)
Tender joint count, week54
|
6.3 count
Standard Deviation 8.6
|
4.8 count
Standard Deviation 7.7
|
4.8 count
Standard Deviation 7.6
|
SECONDARY outcome
Timeframe: 54 weeksThe SJC was determined by examination of 66 joints and identifying when swelling was present. The SJC was recorded on the joint assessment form at each visit, no swelling = 0, swelling =1.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Swollen Joint Count (SJC)
Swollen joint count, baseline
|
14.2 count
Standard Deviation 6.1
|
13.1 count
Standard Deviation 8.4
|
13.7 count
Standard Deviation 7.3
|
|
Swollen Joint Count (SJC)
Swollen joint count, week 54
|
3.6 count
Standard Deviation 4.8
|
3.3 count
Standard Deviation 4.6
|
3.0 count
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 54 weeksThe test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation. Normal range of CRP is 0 mg/dL to 0.3 mg/dL. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
CRP Level
CRP level, baseline
|
2.5 mg/dl
Interval 1.3 to 4.1
|
2.3 mg/dl
Interval 1.3 to 3.5
|
2.3 mg/dl
Interval 1.1 to 4.5
|
|
CRP Level
CRP level, week 54
|
0.5 mg/dl
Interval 0.1 to 2.3
|
0.4 mg/dl
Interval 0.1 to 1.1
|
0.2 mg/dl
Interval 0.1 to 1.0
|
SECONDARY outcome
Timeframe: baseline and week 54DAS28 is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity. A negative change score indicates improvement. Total score range:0 to 9.4, higher score indicated more disease activity. DAS28 =\<3.2 implied low disease activity, \>3.2 to 5.1 implied moderate disease activity, \>5.1 to 9.4 implied high disease activity and \<2.6 implied remission.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Change From Baseline in DAS28
|
-2.30 units on a scale
Standard Deviation 1.56
|
-2.57 units on a scale
Standard Deviation 1.69
|
-2.80 units on a scale
Standard Deviation 1.58
|
SECONDARY outcome
Timeframe: 54 weeksHAQ: patient's 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.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Change From Baseline to Week 54 in HAQ
|
-0.48 units on a scale
Standard Deviation 0.70
|
-0.56 units on a scale
Standard Deviation 0.64
|
-0.59 units on a scale
Standard Deviation 0.63
|
SECONDARY outcome
Timeframe: baseline and week 54The mTSS is a measure of change in joint health. Digitized images of radiographs of hands and feet obtained at screening and Week 54 were scored in a blinded manner. Joints were scored for erosions on a scale of 0 (no damage) to 5 and joint space narrowing on a scale of 0 (no damage) to 4. Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 \[normal\] to 390 \[maximal disease\]). 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 |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Change in Modified Total Sharp Score (mTSS) at week54 From Baseline
|
0.00 score
Interval -1.0 to 1.0
|
0.48 score
Interval -0.5 to 1.64
|
0.00 score
Interval -1.0 to 0.81
|
SECONDARY outcome
Timeframe: 54 weeksSerum level of infliximab was measured by enzyme-linked immunosorbent assay (ELISA), using a monoclonal antibody against infliximab. The lowest level of infliximab that could be reliably detected was 0.1 ug/ml.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 54 weeksATI (antibody to Infliximab) was measured by a modification of an enzyme immunoassay.
Outcome measures
| Measure |
TA-650 3 mg/kg
n=99 Participants
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg
n=104 Participants
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg
n=104 Participants
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
|---|---|---|---|
|
Pharmacokinetics Positive- ATI
|
27 participants
|
24 participants
|
13 participants
|
Adverse Events
TA-650 3 mg/kg (Double-blind)
Serious events: 7 serious events
Other events: 93 other events
Deaths: 0 deaths
TA-650 6 mg/kg (Double-blind)
Serious events: 5 serious events
Other events: 93 other events
Deaths: 0 deaths
TA-650 10 mg/kg (Double-blind)
Serious events: 9 serious events
Other events: 96 other events
Deaths: 0 deaths
Open-label
Serious events: 17 serious events
Other events: 153 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-650 3 mg/kg (Double-blind)
n=99 participants at risk
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg (Double-blind)
n=104 participants at risk
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg (Double-blind)
n=104 participants at risk
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
Open-label
n=327 participants at risk
327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
|
|---|---|---|---|---|
|
Cardiac disorders
Pericardial effusion
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Cardiac disorders
Pericarditis
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Ascites
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Mallory-Weiss syndrome
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Peritonitis
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Cryptococcosis
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.61%
2/327 • 54 weeks
|
|
Infections and infestations
Osteomyelitis
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Pneumonia legionella
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Sepsis
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.61%
2/327 • 54 weeks
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct cancer
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm malignant stage unspecified
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine cancer
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.0%
1/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Eye disorders
Cataract
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Eye disorders
Retinal vein occlusion
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
General disorders
Gait disturbance
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Immune system disorders
Anaphylactoid reaction
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.31%
1/327 • 54 weeks
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
Other adverse events
| Measure |
TA-650 3 mg/kg (Double-blind)
n=99 participants at risk
99 patients received TA-650 at 3mg/kg treatment during the double-blind period starting from week14.
|
TA-650 6 mg/kg (Double-blind)
n=104 participants at risk
104 patients received TA-650 at 6mg/kg treatment during the double-blind period starting from week14.
|
TA-650 10 mg/kg (Double-blind)
n=104 participants at risk
104 patients received TA-650 at 10mg/kg treatment during the double-blind period starting from week14.
|
Open-label
n=327 participants at risk
327 patients received TA-650 at 3 mg/kg treatment during the open-label period.
|
|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/99 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
2.1%
7/327 • 54 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
2/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Eye disorders
Conjunctivitis
|
3.0%
3/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
2/99 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Constipation
|
2.0%
2/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Dental caries
|
2.0%
2/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
2/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
2.1%
7/327 • 54 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Stomach discomfort
|
1.0%
1/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
5.1%
5/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
General disorders
Chest pain
|
0.00%
0/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
General disorders
Malaise
|
0.00%
0/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
General disorders
Pyrexia
|
6.1%
6/99 • 54 weeks
|
5.8%
6/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
3.7%
12/327 • 54 weeks
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
8.1%
8/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
3.4%
11/327 • 54 weeks
|
|
Infections and infestations
Bronchitis
|
2.0%
2/99 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Gastroenteritis
|
3.0%
3/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Nasopharyngitis
|
29.3%
29/99 • 54 weeks
|
27.9%
29/104 • 54 weeks
|
28.8%
30/104 • 54 weeks
|
17.1%
56/327 • 54 weeks
|
|
Infections and infestations
Oral candidiasis
|
2.0%
2/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Paronychia
|
4.0%
4/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Pharyngitis
|
4.0%
4/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Pneumonia
|
4.0%
4/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Sinusitis
|
4.0%
4/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Infections and infestations
Tinea infection
|
1.0%
1/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
3.0%
3/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Alanine aminotransferase increased
|
1.0%
1/99 • 54 weeks
|
11.5%
12/104 • 54 weeks
|
13.5%
14/104 • 54 weeks
|
10.1%
33/327 • 54 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
1.0%
1/99 • 54 weeks
|
7.7%
8/104 • 54 weeks
|
7.7%
8/104 • 54 weeks
|
6.1%
20/327 • 54 weeks
|
|
Investigations
Blood pressure increased
|
1.0%
1/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
3.4%
11/327 • 54 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.0%
2/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Blood urine present
|
3.0%
3/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Heart rate increased
|
0.00%
0/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Liver function test abnormal
|
4.0%
4/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
2.1%
7/327 • 54 weeks
|
|
Investigations
White blood cell count decreased
|
1.0%
1/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
White blood cell count increased
|
3.0%
3/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Protein urine present
|
1.0%
1/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
Antinuclear antibody positive
|
25.3%
25/99 • 54 weeks
|
14.4%
15/104 • 54 weeks
|
16.3%
17/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Investigations
DNA antibody positive
|
65.7%
65/99 • 54 weeks
|
55.8%
58/104 • 54 weeks
|
51.9%
54/104 • 54 weeks
|
4.9%
16/327 • 54 weeks
|
|
Investigations
Cell marker increased
|
2.0%
2/99 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
2/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Nervous system disorders
Dizziness
|
2.0%
2/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
2.1%
7/327 • 54 weeks
|
|
Nervous system disorders
Headache
|
8.1%
8/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
2.1%
7/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
2.0%
2/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/99 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
4.0%
4/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.0%
2/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.96%
1/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
6.1%
6/99 • 54 weeks
|
8.7%
9/104 • 54 weeks
|
8.7%
9/104 • 54 weeks
|
4.0%
13/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
4.0%
4/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
1.9%
2/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.0%
4/99 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
3.0%
3/99 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
4/99 • 54 weeks
|
3.8%
4/104 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.1%
12/99 • 54 weeks
|
11.5%
12/104 • 54 weeks
|
8.7%
9/104 • 54 weeks
|
5.5%
18/327 • 54 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
4/99 • 54 weeks
|
4.8%
5/104 • 54 weeks
|
2.9%
3/104 • 54 weeks
|
0.00%
0/327 • 54 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER