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A Trial to Evaluate the Safety and Tolerability of Namilumab (MT203) in Patients With Mild to Moderate Rheumatoid Arthritis (PRIORA)

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ClinicalTrials.gov Identifier: NCT01317797
Recruitment Status : Completed
First Posted : March 17, 2011
Results First Posted : August 20, 2015
Last Update Posted : August 20, 2015
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: namilumab (MT203)
Drug: Placebo
Enrollment 24
Recruitment Details Participants took part in the study at 10 investigative sites in Bulgaria, Netherlands and Spain from 09 March 2011 to 08 August 2013.
Pre-assignment Details 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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Period Title: Overall Study
Started 8 7 9
Completed 8 6 8
Not Completed 0 1 1
Reason Not Completed
Other             0             1             0
Withdrawal of Patient             0             0             1
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo Total
Hide Arm/Group Description Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. Total of all reporting groups
Overall Number of Baseline Participants 8 7 9 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants 7 participants 9 participants 24 participants
58.0  (6.95) 56.6  (15.28) 53.4  (11.05) 55.9  (11.05)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 9 participants 24 participants
Female
5
  62.5%
6
  85.7%
6
  66.7%
17
  70.8%
Male
3
  37.5%
1
  14.3%
3
  33.3%
7
  29.2%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 8 participants 7 participants 9 participants 24 participants
White 7 7 9 23
Black 1 0 0 1
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 8 participants 7 participants 9 participants 24 participants
166.21  (8.605) 168.57  (6.321) 168.44  (5.126) 167.74  (6.581)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 8 participants 7 participants 9 participants 24 participants
68.13  (7.140) 80.44  (7.305) 77.80  (8.617) 75.35  (9.147)
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 8 participants 7 participants 9 participants 24 participants
24.69  (2.471) 28.30  (1.778) 27.37  (2.246) 26.75  (2.607)
Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 8 participants 7 participants 9 participants 24 participants
4.70  (0.542) 4.66  (0.544) 4.60  (0.512) 4.65  (0.510)
[1]
Measure Description: The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst).
1.Primary Outcome
Title Number of Participants With Clinically Significant Clinical Laboratory Results
Hide Description 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.
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
Haematology 3 0 1
Chemistry 1 1 1
Coagulation 0 0 0
Urine 0 0 0
2.Primary Outcome
Title Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings
Hide Description 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).
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
1 0 0
3.Primary Outcome
Title Number of Participants With Clinically Significant Vital Signs
Hide Description 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).
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
3 0 0
4.Primary Outcome
Title Number of Participants With Clinically Significant Pulmonary Function Tests
Hide Description Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow.
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
0 0 1
5.Primary Outcome
Title Number of Participants With Clinically Significant Physical Examination Findings
Hide Description 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.
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
0 0 0
6.Primary Outcome
Title Number of Participants Reporting One or More Treatment Emergent Adverse Events
Hide Description 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.
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
5 4 5
7.Secondary Outcome
Title Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203
Hide Description Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax
Time Frame Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7
Median (Full Range)
Unit of Measure: days
Day 1
4.98
(3.0 to 7.0)
5.95
(4.0 to 8.2)
Day 29
4.97
(0.1 to 8.0)
6.00
(1.0 to 13.0)
8.Secondary Outcome
Title Cmax: Maximum Observed Plasma Concentration for MT203
Hide Description Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time Frame Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Full Range)
Unit of Measure: μg/mL
Day 1
13.41
(9.988 to 18.02)
18.76
(13.83 to 25.45)
Day 29
27.14
(22.02 to 33.45)
49.99
(40.36 to 61.91)
9.Secondary Outcome
Title AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203
Hide Description 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]).
Time Frame Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Full Range)
Unit of Measure: day*μg/mL
Day 1
144.9
(112.3 to 186.9)
210.9
(151.8 to 292.9)
Day 29
786.8
(666.9 to 928.3)
1696
(1293 to 2225)
10.Secondary Outcome
Title AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203
Hide Description 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).
Time Frame Day 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 6
Geometric Mean (Full Range)
Unit of Measure: day*μg/mL
832.8
(708.8 to 978.4)
1861
(1374 to 2521)
11.Secondary Outcome
Title AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203
Hide Description Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval.
Time Frame Day 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Full Range)
Unit of Measure: day*μg/mL
318.5
(263.2 to 385.5)
591.9
(473.3 to 740.3)
12.Secondary Outcome
Title Terminal Phase Elimination Half-life (T1/2) for MT203
Hide Description Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Time Frame Day 29 (Pre-dose and 2 and 6 hours post-dose)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 6
Mean (Full Range)
Unit of Measure: days
21.26
(13.7 to 34.6)
23.68
(18.6 to 29.9)
13.Secondary Outcome
Title Ctrough: Maximum Observed Plasma Concentration Pre-Dose
Hide Description [Not Specified]
Time Frame Days 1, 15 and 29 Pre-dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7
Geometric Mean (Full Range)
Unit of Measure: μg/mL
Day 1
9.232
(7.543 to 11.30)
14.56
(11.33 to 18.72)
Day 15
15.53
(13.03 to 18.50)
27.28
(18.89 to 39.41)
Day 29
20.27
(16.74 to 24.53)
36.88
(31.85 to 42.70)
14.Secondary Outcome
Title Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma
Hide Description 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.
Time Frame Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available for analysis.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 2 (n=7, 7, 9) 0.00  (0.000) -0.86  (2.268) 0.67  (2.000)
Day 4 (n=6, 7, 9) 3.00  (3.286) 0.86  (4.140) 0.00  (0.000)
Day 6 (n=6, 7, 9) 3.00  (3.286) 2.57  (3.207) 0.00  (0.000)
Day 8 (n=6, 7, 9) 7.78  (10.330) 4.29  (2.928) 0.00  (0.000)
Day 15 (n=7, 7, 9) 16.86  (8.825) 8.61  (8.978) 0.00  (0.000)
Day 29 (n=7, 7, 8) 31.59  (13.323) 15.14  (6.690) 0.00  (0.000)
Day 30 (n=6, 7, 8) 40.68  (24.908) 22.11  (16.954) 0.75  (2.121)
Day 35 (n=7, 7, 7) 33.29  (20.203) 25.71  (16.261) 0.00  (0.000)
Day 43 (n=7, 7, 8) 40.04  (18.838) 28.10  (15.013) 0.00  (0.000)
Day 56 (n=7, 6, 8) 38.34  (20.330) 32.32  (14.337) 0.75  (2.121)
Day 71 (n=5, 6, 8) 31.48  (21.759) 35.02  (12.402) 0.75  (2.121)
Day 99 (n=7, 6, 7) 9.11  (11.113) 23.77  (8.881) 0.00  (0.000)
EOT (n=7, 6, 9) 3.87  (7.919) 17.38  (10.745) 0.67  (2.000)
15.Secondary Outcome
Title Change From Baseline in MT203/GM-CSF Complexes in Plasma
Hide Description 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.
Time Frame Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available for analysis.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Mean (Standard Deviation)
Unit of Measure: pg/mL
Day 2 (n=8, 7, 9) 30.9  (63.92) 12.7  (16.25) -0.2  (0.67)
Day 4 (n=8, 7, 9) 210.6  (183.16) 186.1  (100.15) -0.6  (1.67)
Day 6 (n=8, 7, 9) 381.6  (152.52) 334.6  (89.19) -1.3  (4.00)
Day 8 (n=8, 7, 9) 448.0  (110.76) 534.1  (80.58) -1.3  (4.00)
Day 15 (n=8, 7, 9) 1021.0  (353.03) 1055.0  (124.65) -3.9  (11.67)
Day 29 (n=8, 7, 8) 1566.9  (391.80) 1805.4  (150.43) -4.4  (12.37)
Day 30 (n=8, 7, 8) 1653.5  (498.31) 1834.9  (178.71) -4.4  (12.37)
Day 35 (n=8, 7, 8) 1796.9  (560.58) 2052.9  (294.95) -4.4  (12.37)
Day 43 (n=8, 7, 8) 2213.0  (744.37) 2290.6  (282.35) -4.4  (12.37)
Day 56 (n=8, 6, 8) 2009.0  (614.92) 2457.2  (466.01) -4.4  (12.37)
Day 71 (n=8, 6, 8) 1299.6  (313.20) 2312.2  (492.50) -4.4  (12.37)
Day 99 (n=8, 6, 8) 462.6  (275.40) 1753.5  (351.34) -4.4  (12.37)
EOT (n=8, 6, 9) 310.4  (144.03) 1310.8  (460.45) -3.9  (11.67)
16.Secondary Outcome
Title Number of Participants With Anti-MT203 Antibodies
Hide Description Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay).
Time Frame From Day 1 Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety population included all randomized participants who received study drug.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: participants
0 0 0
17.Secondary Outcome
Title Percentage of Participants With American College of Rheumatology (ACR 20) Response
Hide Description 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.
Time Frame Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available for analysis.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Measure Type: Number
Unit of Measure: percentage of participants
Day 13 50.0 14.3 11.1
Day 27 50.0 57.1 33.3
Day 43 37.5 71.4 44.4
Day 56 50.0 57.1 55.6
Day 71 62.5 57.1 44.4
Day 99 50.0 42.9 44.4
EOT 37.5 57.1 44.4
18.Secondary Outcome
Title Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR)
Hide Description 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.
Time Frame Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants with data available for analysis.
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description:
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
Overall Number of Participants Analyzed 8 7 9
Mean (Standard Deviation)
Unit of Measure: score on a scale
Day 13 (n=8, 7, 9) -0.473  (0.7412) -0.310  (0.5369) -0.344  (0.6491)
Day 27 (n=8, 7, 9) -0.798  (0.6432) -0.995  (0.7094) -0.383  (0.7425)
Day 43 (n=8, 7, 8) -0.873  (0.6064) -0.852  (0.8223) -0.469  (0.6585)
Day 56 (n=8, 6, 8) -1.002  (0.9624) -1.190  (0.8217) -1.184  (1.0178)
Day 71 (n=7, 6, 7) -0.853  (0.4461) -0.980  (0.7478) -1.134  (1.1240)
Day 99 (n=8, 6, 8) -0.678  (0.4345) -0.914  (0.7782) -1.025  (0.8533)
EOT (n=8, 6, 9) -0.591  (0.5664) -0.974  (0.5992) -1.138  (0.9667)
Time Frame From Day 1 Up to Day 118
Adverse Event Reporting Description 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.
 
Arm/Group Title Namilumab 150 mg Namilumab 300 mg Placebo
Hide Arm/Group Description Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
All-Cause Mortality
Namilumab 150 mg Namilumab 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Namilumab 150 mg Namilumab 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/8 (25.00%)   0/7 (0.00%)   0/9 (0.00%) 
Cardiac disorders       
Coronary artery stenosis  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Non-small cell lung cancer stage IIIa  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Namilumab 150 mg Namilumab 300 mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/8 (62.50%)   4/7 (57.14%)   5/9 (55.56%) 
Blood and lymphatic system disorders       
Thrombocytosis  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Cardiac disorders       
Bradycardia  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Eye disorders       
Vitreous detachment  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Diarrhoea  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Abdominal pain  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
General disorders       
Chest discomfort  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Chest pain  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Influenza like illness  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Infections and infestations       
Nasopharyngitis  1  2/8 (25.00%)  0/7 (0.00%)  2/9 (22.22%) 
Urinary tract infection  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Investigations       
Blood creatine phosphokinase increased  1  0/8 (0.00%)  1/7 (14.29%)  1/9 (11.11%) 
Body temperature increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Alanine aminotransferase increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Blood lactate dehydrogenase increased  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Blood pressure diastolic increased  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Blood pressure systolic increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
C-reactive protein increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Haemoglobin urine present  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Mean cell volume increased  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Red blood cell sedimentation rate increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Red blood cells urine positive  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Urine ketone body present  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
White blood cell count increased  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Musculoskeletal and connective tissue disorders       
Rheumatoid arthritis  1  1/8 (12.50%)  0/7 (0.00%)  2/9 (22.22%) 
Musculoskeletal pain  1  2/8 (25.00%)  0/7 (0.00%)  0/9 (0.00%) 
Pain in extremity  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Muscular weakness  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Nervous system disorders       
Paraesthesia  1  1/8 (12.50%)  0/7 (0.00%)  0/9 (0.00%) 
Somnolence  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Renal and urinary disorders       
Dysuria  1  0/8 (0.00%)  0/7 (0.00%)  1/9 (11.11%) 
Nephrolithiasis  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Dyspnoea  1  0/8 (0.00%)  1/7 (14.29%)  0/9 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 13.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director, Clinical Science
Organization: Takeda
Phone: +1-877-825-3327
Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01317797     History of Changes
Other Study ID Numbers: M1-1188-002-EM
2010-018502-36 ( EudraCT Number )
U1111-1137-3923 ( Registry Identifier: WHO )
NL33507.058.10 ( Registry Identifier: CCMO )
First Submitted: February 18, 2011
First Posted: March 17, 2011
Results First Submitted: July 24, 2015
Results First Posted: August 20, 2015
Last Update Posted: August 20, 2015