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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018502-36 | EudraCT Number | ||
| U1111-1137-3923 | Registry Identifier | WHO | |
| NL33507.058.10 | Registry Identifier | CCMO |
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The purpose of this trial is primarily to investigate the safety and tolerability of repeated subcutaneous injections of MT203 in patients with mild to moderate rheumatoid arthritis. Furthermore, the amount of MT203 in the blood will be measured and it will be investigated how the body responds to MT203 treatment and if MT203 is effective in the treatment of rheumatoid arthritis.
The trial medication will be administered at 2 dose levels as subcutaneous injections. Each patient will receive three injections in total. The trial duration consists of a screening period (28 - 2 days prior to the first injection) and a treatment and observation period (4 months). The trial requires approximately 20 visits at the study site.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Namilumab 150 mg | Experimental | Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
|
| Namilumab 300 mg | Experimental | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. |
|
| Placebo | Placebo Comparator | Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| namilumab (MT203) | Drug | administered three times, subcutaneous in the abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Clinically Significant Clinical Laboratory Results | 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. | From Day 1 Up to Day 118 |
| Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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). | From Day 1 Up to Day 118 |
| Number of Participants With Clinically Significant Vital Signs | 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). | From Day 1 Up to Day 118 |
| Number of Participants With Clinically Significant Pulmonary Function Tests | Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow. | From Day 1 Up to Day 118 |
| Number of Participants With Clinically Significant Physical Examination Findings |
| Measure | Description | Time Frame |
|---|---|---|
| Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax | Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
| Cmax: Maximum Observed Plasma Concentration for MT203 |
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Inclusion Criteria:
In addition, heterosexually active male and female patients of childbearing potential are required to use effective double-method contraception (one hormonal contraceptive or intrauterine device and one other additional contraceptive method) for 1 month before the first administration of the IMP, during the course of the trial, and for 6 month after the last injection of MT203.
No special requirements are made for female patients proven to be post-menopausal (at least 2 years after last menstrual period and FSH ≥ 40IU/L), surgically sterilized or hysterectomized. Likewise no special requirements for heterosexually active male who are surgical sterilized.
Pregnant or lactating female patients have to be excluded.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nycomed Investigational Site | Sofia | Bulgaria | ||||
| Nycomed Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28274253 | Derived | Huizinga TW, Batalov A, Stoilov R, Lloyd E, Wagner T, Saurigny D, Souberbielle B, Esfandiari E. Phase 1b randomized, double-blind study of namilumab, an anti-granulocyte macrophage colony-stimulating factor monoclonal antibody, in mild-to-moderate rheumatoid arthritis. Arthritis Res Ther. 2017 Mar 9;19(1):53. doi: 10.1186/s13075-017-1267-3. |
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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.
Participants took part in the study at 10 investigative sites in Bulgaria, Netherlands and Spain from 09 March 2011 to 08 August 2013.
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| ID | Title | Description |
|---|---|---|
| FG000 | Namilumab 150 mg | Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
| FG001 | Namilumab 300 mg | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. |
| FG002 | Placebo | Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | Namilumab 150 mg | Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
| BG001 | Namilumab 300 mg | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Clinically Significant Clinical Laboratory Results | 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. | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Namilumab 150 mg | Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non-small cell lung cancer stage IIIa | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director, Clinical Science | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C000624713 | namilumab |
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| Placebo | Drug | administered three times, subcutaneous in the abdomen |
|
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. |
| From Day 1 Up to Day 118 |
| Number of Participants Reporting One or More Treatment Emergent Adverse Events | 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. | From Day 1 Up to Day 118 |
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. |
| Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
| AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203 | 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]). | Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
| AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203 | 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). | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
| AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203 | Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval. | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
| Terminal Phase Elimination Half-life (T1/2) for MT203 | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
| Ctrough: Maximum Observed Plasma Concentration Pre-Dose | Days 1, 15 and 29 Pre-dose |
| Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma | 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. | Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118 |
| Change From Baseline in MT203/GM-CSF Complexes in Plasma | 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. | Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118 |
| Number of Participants With Anti-MT203 Antibodies | Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay). | From Day 1 Up to Day 118 |
| Percentage of Participants With American College of Rheumatology (ACR 20) Response | 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. | Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 |
| Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR) | 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. | Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 |
| Leids |
| Netherlands |
| BG002 | Placebo | Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Disease Activity Score 28-Erythrocyte Sedimentation Rate (DAS28-ESR) Score | The DAS28-ESR is expressed on a unit on a scale with the minimum score=0 (best) to maximum score=10 (worst). | Mean | Standard Deviation | score on a scale |
|
| Namilumab 150 mg |
Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29. |
| OG001 | Namilumab 300 mg | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. |
| OG002 | Placebo | Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. |
|
|
| Primary | Number of Participants With Clinically Significant Electrocardiogram (ECG) Findings | 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). | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Primary | Number of Participants With Clinically Significant Vital Signs | 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). | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Primary | Number of Participants With Clinically Significant Pulmonary Function Tests | Pulmonary function was determined by forced expiratory volume in the first second (FEV1), forced vital capacity (FVC) and peak flow. | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Primary | Number of Participants With Clinically Significant Physical Examination Findings | 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. | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Primary | Number of Participants Reporting One or More Treatment Emergent Adverse Events | 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. | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Secondary | Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for MT203 | Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax | Posted | Median | Full Range | days | Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | Cmax: Maximum Observed Plasma Concentration for MT203 | Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve. | 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. | Posted | Geometric Mean | Full Range | μg/mL | Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | AUC(0-tlqc): Area Under the Plasma Concentration-Time Curve From Time 0 to the Time of the Last Quantifiable Concentration for MT203 | 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]). | 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. | Posted | Geometric Mean | Full Range | day*μg/mL | Day 1 and 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for MT203 | 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). | 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. | Posted | Geometric Mean | Full Range | day*μg/mL | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | AUC(0-tau): Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for MT203 | Area under the plasma concentration-time curve during a dosing interval, where tau is the length of the dosing interval. | 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. | Posted | Geometric Mean | Full Range | day*μg/mL | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | Terminal Phase Elimination Half-life (T1/2) for MT203 | Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma. | PK Analysis set included all 15 participants who were exposed to study drug for whom any PK parameters could be calculated. | Posted | Mean | Full Range | days | Day 29 (Pre-dose and 2 and 6 hours post-dose) |
|
|
|
| Secondary | Ctrough: Maximum Observed Plasma Concentration Pre-Dose | 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. | Posted | Geometric Mean | Full Range | μg/mL | Days 1, 15 and 29 Pre-dose |
|
|
|
| Secondary | Change From Baseline in Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Plasma | 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. | All randomized participants with data available for analysis. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, End of trial (EOT) Up to Day 118 |
|
|
|
| Secondary | Change From Baseline in MT203/GM-CSF Complexes in Plasma | 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. | All randomized participants with data available for analysis. | Posted | Mean | Standard Deviation | pg/mL | Baseline and Days 2, 4, 6, 8 15, 29, 30, 35, 43, 56, 71, 99, EOT Up to Day 118 |
|
|
|
| Secondary | Number of Participants With Anti-MT203 Antibodies | Serum samples were tested for the presence of anti-MT203 antibodies by a bridging Electro-chemi-luminescent assay (ECL-assay). | Safety population included all randomized participants who received study drug. | Posted | Number | participants | From Day 1 Up to Day 118 |
|
|
|
| Secondary | Percentage of Participants With American College of Rheumatology (ACR 20) Response | 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. | All randomized participants with data available for analysis. | Posted | Number | percentage of participants | Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 |
|
|
|
| Secondary | Change From Baseline in the Disease Activity Score 44-Erythrocyte Sedimentation Rate (DAS44-ESR) | 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. | All randomized participants with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline and Days 13,27,43,56,71,99 and EOT Up to Day 118 |
|
|
|
| 2 |
| 8 |
| 5 |
| 8 |
| EG001 | Namilumab 300 mg | Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29. | 0 | 7 | 4 | 7 |
| EG002 | Placebo | Namilumab-matching placebo, SC injection, on Days 1, 15 and 29. | 0 | 9 | 5 | 9 |
| Coronary artery stenosis | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 13.1 | Systematic Assessment |
|
| Thrombocytosis | Blood and lymphatic system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 13.1 | Systematic Assessment |
|
| Vitreous detachment | Eye disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA 13.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood lactate dehydrogenase increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood pressure diastolic increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Blood pressure systolic increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Haemoglobin urine present | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Mean cell volume increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Red blood cell sedimentation rate increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Urine ketone body present | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 13.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA 13.1 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.1 | Systematic Assessment |
|
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.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Day 29 |
|
|
| Day 6 (n=6, 7, 9) |
|
| Day 8 (n=6, 7, 9) |
|
| Day 15 (n=7, 7, 9) |
|
| Day 29 (n=7, 7, 8) |
|
| Day 30 (n=6, 7, 8) |
|
| Day 35 (n=7, 7, 7) |
|
| Day 43 (n=7, 7, 8) |
|
| Day 56 (n=7, 6, 8) |
|
| Day 71 (n=5, 6, 8) |
|
| Day 99 (n=7, 6, 7) |
|
| EOT (n=7, 6, 9) |
|
|
| Day 6 (n=8, 7, 9) |
|
| Day 8 (n=8, 7, 9) |
|
| Day 15 (n=8, 7, 9) |
|
| Day 29 (n=8, 7, 8) |
|
| Day 30 (n=8, 7, 8) |
|
| Day 35 (n=8, 7, 8) |
|
| Day 43 (n=8, 7, 8) |
|
| Day 56 (n=8, 6, 8) |
|
| Day 71 (n=8, 6, 8) |
|
| Day 99 (n=8, 6, 8) |
|
| EOT (n=8, 6, 9) |
|
| Title | Measurements |
|---|---|
|
| Day 43 |
|
| Day 56 |
|
| Day 71 |
|
| Day 99 |
|
| EOT |
|
|
| Day 43 (n=8, 7, 8) |
|
| Day 56 (n=8, 6, 8) |
|
| Day 71 (n=7, 6, 7) |
|
| Day 99 (n=8, 6, 8) |
|
| EOT (n=8, 6, 9) |
|