Trial Outcomes & Findings for A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis (NCT NCT01317797)
NCT ID: NCT01317797
Last Updated: 2015-08-20
Results Overview
Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): \> 3 times upper limit of normal (ULN). Creatinine and Glucose: \> 2 times ULN. Potassium \> 6.0 or \< 3.0 mmol/L. Haemoglobin: Male \< 8.0 ;Female \< 7.0 g/dL. Erythrocytes :Male \< 3.5 x 10\^12/L or \> 7 x 10\^12/L;Female \< 3.0 x 10\^12/L or \> 6.5 x 10\^12/L. White Blood Cells (WBC): \< 2.8 x10\^9/L or \> 16.0 x 10\^9/L. Eosinophils \> 20 % of cells in the WBC differential. Platelet Count \< 75 x 10\^9/L or 600 x 10\^9/L. No alert values were identified for Coagulation or Urinalysis.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
24 participants
Primary outcome timeframe
From Day 1 Up to Day 118
Results posted on
2015-08-20
Participant Flow
Participants took part in the study at 10 investigative sites in Bulgaria, Netherlands and Spain from 09 March 2011 to 08 August 2013.
Participants with a diagnosis of mild or moderate rheumatoid arthritis were enrolled into 1 of 3 treatment groups namilumab (MT203) 150mg, namilumab 300 mg or placebo.
Participant milestones
| Measure |
Namilumab 150 mg
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
7
|
9
|
|
Overall Study
COMPLETED
|
8
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Namilumab 150 mg
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Withdrawal of Patient
|
0
|
0
|
1
|
Baseline Characteristics
A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis
Baseline characteristics by cohort
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 6.95 • n=5 Participants
|
56.6 years
STANDARD_DEVIATION 15.28 • n=7 Participants
|
53.4 years
STANDARD_DEVIATION 11.05 • n=5 Participants
|
55.9 years
STANDARD_DEVIATION 11.05 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
9 participants
n=5 Participants
|
23 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Height
|
166.21 cm
STANDARD_DEVIATION 8.605 • n=5 Participants
|
168.57 cm
STANDARD_DEVIATION 6.321 • n=7 Participants
|
168.44 cm
STANDARD_DEVIATION 5.126 • n=5 Participants
|
167.74 cm
STANDARD_DEVIATION 6.581 • n=4 Participants
|
|
Weight
|
68.13 kg
STANDARD_DEVIATION 7.140 • n=5 Participants
|
80.44 kg
STANDARD_DEVIATION 7.305 • n=7 Participants
|
77.80 kg
STANDARD_DEVIATION 8.617 • n=5 Participants
|
75.35 kg
STANDARD_DEVIATION 9.147 • n=4 Participants
|
|
Body Mass Index (BMI)
|
24.69 kg/m^2
STANDARD_DEVIATION 2.471 • n=5 Participants
|
28.30 kg/m^2
STANDARD_DEVIATION 1.778 • n=7 Participants
|
27.37 kg/m^2
STANDARD_DEVIATION 2.246 • n=5 Participants
|
26.75 kg/m^2
STANDARD_DEVIATION 2.607 • n=4 Participants
|
|
Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score
|
4.70 score on a scale
STANDARD_DEVIATION 0.542 • n=5 Participants
|
4.66 score on a scale
STANDARD_DEVIATION 0.544 • n=7 Participants
|
4.60 score on a scale
STANDARD_DEVIATION 0.512 • n=5 Participants
|
4.65 score on a scale
STANDARD_DEVIATION 0.510 • n=4 Participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
Blood was collected for Haematology, Chemistry and Coagulation. Urine was collected for Urinalysis. Alert values for laboratory results include the following: Aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), gamma-glutamyl-transpeptidase (GGT), alkaline phosphatase (AP), total bilirubin (TBil): \> 3 times upper limit of normal (ULN). Creatinine and Glucose: \> 2 times ULN. Potassium \> 6.0 or \< 3.0 mmol/L. Haemoglobin: Male \< 8.0 ;Female \< 7.0 g/dL. Erythrocytes :Male \< 3.5 x 10\^12/L or \> 7 x 10\^12/L;Female \< 3.0 x 10\^12/L or \> 6.5 x 10\^12/L. White Blood Cells (WBC): \< 2.8 x10\^9/L or \> 16.0 x 10\^9/L. Eosinophils \> 20 % of cells in the WBC differential. Platelet Count \< 75 x 10\^9/L or 600 x 10\^9/L. No alert values were identified for Coagulation or Urinalysis.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Clinical Laboratory Results
Coagulation
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Significant Clinical Laboratory Results
Haematology
|
3 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Clinical Laboratory Results
Chemistry
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Clinically Significant Clinical Laboratory Results
Urine
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
Alert values for ECG were: Heart rate \< 35 bpm or \> 120 bpm, QTc acc. to Bazett (absolute value)\> 500 ms or QTc acc. to Bazett (increase versus Baseline (pre-treatment).
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
|
1 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
Vital signs included Systolic Blood Pressure (BP), Diastolic BP, body temperature, heart rate. Alert values were: BP systolic \> 170 mmHg or \< 85 mmHg, BP diastolic \> 105 mmHg, Difference BP systolic vs. Baseline (pre-treatment) \> 40 mmHg or Pulse rate \< 35 bpm or \> 120 beats per minute (bpm).
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs
|
3 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Pulmonary Function Tests
|
0 participants
|
0 participants
|
1 participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
The physical examination included body system assessments: eyes, head and neck (including thyroid), ears, nose and throat, lymph nodes, cardiovascular, lungs, mammae, abdomen (liver, spleen), genitals, limbs, central and peripheral nervous system, musculoskeletal system, skin \& nails, mucosae. The Investigator classified abnormal findings as either clinically significant or not clinically significant.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant Physical Examination Findings
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants Reporting One or More Treatment Emergent Adverse Events
|
5 participants
|
4 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203
Day 1
|
4.98 days
Interval 3.0 to 7.0
|
5.95 days
Interval 4.0 to 8.2
|
—
|
|
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203
Day 29
|
4.97 days
Interval 0.1 to 8.0
|
6.00 days
Interval 1.0 to 13.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)Population: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Cmax: Maximum Observed Plasma Concentration for MT203
Day 1
|
13.41 μg/mL
Interval 9.988 to 18.02
|
18.76 μg/mL
Interval 13.83 to 25.45
|
—
|
|
Cmax: Maximum Observed Plasma Concentration for MT203
Day 29
|
27.14 μg/mL
Interval 22.02 to 33.45
|
49.99 μg/mL
Interval 40.36 to 61.91
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)Population: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC\[0-tlqc\]).
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203
Day 1
|
144.9 day*μg/mL
Interval 112.3 to 186.9
|
210.9 day*μg/mL
Interval 151.8 to 292.9
|
—
|
|
AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203
Day 29
|
786.8 day*μg/mL
Interval 666.9 to 928.3
|
1696 day*μg/mL
Interval 1293.0 to 2225.0
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Pre-dose and 2 and 6 hours post-dose)Population: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.
AUC(0-inf) is measure of area under the curve over the dosing interval (tau) (AUC(0-tau\]), where tau is the length of the dosing interval in this study).
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=6 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203
|
832.8 day*μg/mL
Interval 708.8 to 978.4
|
1861 day*μg/mL
Interval 1374.0 to 2521.0
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Pre-dose and 2 and 6 hours post-dose)Population: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.
Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203
|
318.5 day*μg/mL
Interval 263.2 to 385.5
|
591.9 day*μg/mL
Interval 473.3 to 740.3
|
—
|
SECONDARY outcome
Timeframe: Day 29 (Pre-dose and 2 and 6 hours post-dose)Population: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=6 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Terminal Phase Elimination Half-life (T1/2) for MT203
|
21.26 days
Interval 13.7 to 34.6
|
23.68 days
Interval 18.6 to 29.9
|
—
|
SECONDARY outcome
Timeframe: Days 1, 15 and 29 Pre-dosePopulation: PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. Method of Dispersion is the 68% range.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Ctrough: Maximum Observed Plasma Concentration Pre-Dose
Day 1
|
9.232 μg/mL
Interval 7.543 to 11.3
|
14.56 μg/mL
Interval 11.33 to 18.72
|
—
|
|
Ctrough: Maximum Observed Plasma Concentration Pre-Dose
Day 15
|
15.53 μg/mL
Interval 13.03 to 18.5
|
27.28 μg/mL
Interval 18.89 to 39.41
|
—
|
|
Ctrough: Maximum Observed Plasma Concentration Pre-Dose
Day 29
|
20.27 μg/mL
Interval 16.74 to 24.53
|
36.88 μg/mL
Interval 31.85 to 42.7
|
—
|
SECONDARY outcome
Timeframe: Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118Population: All randomized participants with data available for analysis.
MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 8 (n=6, 7, 9)
|
7.78 pg/mL
Standard Deviation 10.330
|
4.29 pg/mL
Standard Deviation 2.928
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 15 (n=7, 7, 9)
|
16.86 pg/mL
Standard Deviation 8.825
|
8.61 pg/mL
Standard Deviation 8.978
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 30 (n=6, 7, 8)
|
40.68 pg/mL
Standard Deviation 24.908
|
22.11 pg/mL
Standard Deviation 16.954
|
0.75 pg/mL
Standard Deviation 2.121
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 2 (n=7, 7, 9)
|
0.00 pg/mL
Standard Deviation 0.000
|
-0.86 pg/mL
Standard Deviation 2.268
|
0.67 pg/mL
Standard Deviation 2.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 4 (n=6, 7, 9)
|
3.00 pg/mL
Standard Deviation 3.286
|
0.86 pg/mL
Standard Deviation 4.140
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 6 (n=6, 7, 9)
|
3.00 pg/mL
Standard Deviation 3.286
|
2.57 pg/mL
Standard Deviation 3.207
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 29 (n=7, 7, 8)
|
31.59 pg/mL
Standard Deviation 13.323
|
15.14 pg/mL
Standard Deviation 6.690
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 35 (n=7, 7, 7)
|
33.29 pg/mL
Standard Deviation 20.203
|
25.71 pg/mL
Standard Deviation 16.261
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 43 (n=7, 7, 8)
|
40.04 pg/mL
Standard Deviation 18.838
|
28.10 pg/mL
Standard Deviation 15.013
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 56 (n=7, 6, 8)
|
38.34 pg/mL
Standard Deviation 20.330
|
32.32 pg/mL
Standard Deviation 14.337
|
0.75 pg/mL
Standard Deviation 2.121
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 71 (n=5, 6, 8)
|
31.48 pg/mL
Standard Deviation 21.759
|
35.02 pg/mL
Standard Deviation 12.402
|
0.75 pg/mL
Standard Deviation 2.121
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Day 99 (n=7, 6, 7)
|
9.11 pg/mL
Standard Deviation 11.113
|
23.77 pg/mL
Standard Deviation 8.881
|
0.00 pg/mL
Standard Deviation 0.000
|
|
Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
EOT (n=7, 6, 9)
|
3.87 pg/mL
Standard Deviation 7.919
|
17.38 pg/mL
Standard Deviation 10.745
|
0.67 pg/mL
Standard Deviation 2.000
|
SECONDARY outcome
Timeframe: Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118Population: All randomized participants with data available for analysis.
MT203/GM-CSF complexes were analysed using a procedure that quantified GM-CSF after dissociation from the complex. The determined concentrations corresponded to the amount of total (free and complexed) GM-CSF in the plasma sample. A positive change from Baseline indicated improvement.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 43 (n=8, 7, 8)
|
2213.0 pg/mL
Standard Deviation 744.37
|
2290.6 pg/mL
Standard Deviation 282.35
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 2 (n=8, 7, 9)
|
30.9 pg/mL
Standard Deviation 63.92
|
12.7 pg/mL
Standard Deviation 16.25
|
-0.2 pg/mL
Standard Deviation 0.67
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 4 (n=8, 7, 9)
|
210.6 pg/mL
Standard Deviation 183.16
|
186.1 pg/mL
Standard Deviation 100.15
|
-0.6 pg/mL
Standard Deviation 1.67
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 6 (n=8, 7, 9)
|
381.6 pg/mL
Standard Deviation 152.52
|
334.6 pg/mL
Standard Deviation 89.19
|
-1.3 pg/mL
Standard Deviation 4.00
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 8 (n=8, 7, 9)
|
448.0 pg/mL
Standard Deviation 110.76
|
534.1 pg/mL
Standard Deviation 80.58
|
-1.3 pg/mL
Standard Deviation 4.00
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 15 (n=8, 7, 9)
|
1021.0 pg/mL
Standard Deviation 353.03
|
1055.0 pg/mL
Standard Deviation 124.65
|
-3.9 pg/mL
Standard Deviation 11.67
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 29 (n=8, 7, 8)
|
1566.9 pg/mL
Standard Deviation 391.80
|
1805.4 pg/mL
Standard Deviation 150.43
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 30 (n=8, 7, 8)
|
1653.5 pg/mL
Standard Deviation 498.31
|
1834.9 pg/mL
Standard Deviation 178.71
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 35 (n=8, 7, 8)
|
1796.9 pg/mL
Standard Deviation 560.58
|
2052.9 pg/mL
Standard Deviation 294.95
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 56 (n=8, 6, 8)
|
2009.0 pg/mL
Standard Deviation 614.92
|
2457.2 pg/mL
Standard Deviation 466.01
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 71 (n=8, 6, 8)
|
1299.6 pg/mL
Standard Deviation 313.20
|
2312.2 pg/mL
Standard Deviation 492.50
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
Day 99 (n=8, 6, 8)
|
462.6 pg/mL
Standard Deviation 275.40
|
1753.5 pg/mL
Standard Deviation 351.34
|
-4.4 pg/mL
Standard Deviation 12.37
|
|
Change From Baseline in MT203/GM-CSF Complexes in Plasma
EOT (n=8, 6, 9)
|
310.4 pg/mL
Standard Deviation 144.03
|
1310.8 pg/mL
Standard Deviation 460.45
|
-3.9 pg/mL
Standard Deviation 11.67
|
SECONDARY outcome
Timeframe: From Day 1 Up to Day 118Population: Safety population included all randomized participants who received study drug.
Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Number of Participants With Anti-MT203 Antibodies
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118Population: All randomized participants with data available for analysis.
ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant Erythrocyte Sedimentation Rate.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 27
|
50.0 percentage of participants
|
57.1 percentage of participants
|
33.3 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 43
|
37.5 percentage of participants
|
71.4 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 56
|
50.0 percentage of participants
|
57.1 percentage of participants
|
55.6 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 99
|
50.0 percentage of participants
|
42.9 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
EOT
|
37.5 percentage of participants
|
57.1 percentage of participants
|
44.4 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 13
|
50.0 percentage of participants
|
14.3 percentage of participants
|
11.1 percentage of participants
|
|
Percentage of Participants With American College of Rheumatology (ACR 20) Response
Day 71
|
62.5 percentage of participants
|
57.1 percentage of participants
|
44.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118Population: All randomized participants with data available for analysis.
Ritchie articular index (RAI); a joint count that grades the tenderness of 26 joints on a scale of 0-3); the number of swollen joints from 44 joints (swollen44); ESR in mm/hour after 1 hour and the patient's global disease activity on a Visual Analogue Scale (VAS) of 100 mm (0=no disease activity to right end of the line 100=maximum disease activity) were used to calculate DAS44-ESR using the following formula: DAS44-ESR = 0.54\*sqrt(RAI) + 0.065\*(swollen44) + 0.33\*ln(ESR) + 0.0072\*VAS. Lower numbers were better. A negative change from Baseline indicated improvement.
Outcome measures
| Measure |
Namilumab 150 mg
n=8 Participants
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 Participants
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 Participants
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 13 (n=8, 7, 9)
|
-0.473 score on a scale
Standard Deviation 0.7412
|
-0.310 score on a scale
Standard Deviation 0.5369
|
-0.344 score on a scale
Standard Deviation 0.6491
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 27 (n=8, 7, 9)
|
-0.798 score on a scale
Standard Deviation 0.6432
|
-0.995 score on a scale
Standard Deviation 0.7094
|
-0.383 score on a scale
Standard Deviation 0.7425
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 43 (n=8, 7, 8)
|
-0.873 score on a scale
Standard Deviation 0.6064
|
-0.852 score on a scale
Standard Deviation 0.8223
|
-0.469 score on a scale
Standard Deviation 0.6585
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 56 (n=8, 6, 8)
|
-1.002 score on a scale
Standard Deviation 0.9624
|
-1.190 score on a scale
Standard Deviation 0.8217
|
-1.184 score on a scale
Standard Deviation 1.0178
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 71 (n=7, 6, 7)
|
-0.853 score on a scale
Standard Deviation 0.4461
|
-0.980 score on a scale
Standard Deviation 0.7478
|
-1.134 score on a scale
Standard Deviation 1.1240
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Day 99 (n=8, 6, 8)
|
-0.678 score on a scale
Standard Deviation 0.4345
|
-0.914 score on a scale
Standard Deviation 0.7782
|
-1.025 score on a scale
Standard Deviation 0.8533
|
|
Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
EOT (n=8, 6, 9)
|
-0.591 score on a scale
Standard Deviation 0.5664
|
-0.974 score on a scale
Standard Deviation 0.5992
|
-1.138 score on a scale
Standard Deviation 0.9667
|
Adverse Events
Namilumab 150 mg
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Namilumab 300 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Namilumab 150 mg
n=8 participants at risk
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 participants at risk
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 participants at risk
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer stage IIIa
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
Namilumab 150 mg
n=8 participants at risk
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
|
Namilumab 300 mg
n=7 participants at risk
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
|
Placebo
n=9 participants at risk
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
2/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
25.0%
2/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
22.2%
2/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
General disorders
Influenza like illness
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Body temperature increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Blood pressure systolic increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
C-reactive protein increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Haemoglobin urine present
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Mean cell volume increased
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Red blood cell sedimentation rate increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Urine ketone body present
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
White blood cell count increased
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
11.1%
1/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
14.3%
1/7 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
0.00%
0/9 • From Day 1 Up to Day 118
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER