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Multiple sclerosis (MS) is a chronic inflammatory disease associated with central nervous system (CNS) demyelination and subsequent axonal degeneration. Multiple sclerosis exhibits an unpredictable and variable clinical course.
Multiple sclerosis plaques contain numerous types of cells and infiltrating macrophages have been identified to contribute significantly to demyelination in both clinical MS and animal models of MS. Granulocyte-macrophage colony-stimulating factor (GM CSF) stimulates proliferation and activation of macrophages, monocytes, neutrophils, eosinophils, dendritic cells and microglia with subsequent induction of proinflammatory biomolecules.
Therefore blocking GM CSF activity might be a therapeutic approach for the treatment of MS.
Recent clinical studies demonstrated a possible dysregulation of the balance of pro and anti inflammatory lymphocytes, which may contribute to the pathogenesis of MS.
It was shown in animal models of EAE that during the disease effect or phase GM CSF sustained neuroinflammation via myeloid cells that infiltrate the CNS proving an essential role of GM CSF in encephalitogenicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MOR103 0.5 mg/kg | Experimental | 6 doses of MOR103 0.5 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6). |
|
| MOR103 1.0 mg/kg | Experimental | 6 doses of MOR103 1.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6). |
|
| MOR103 2.0 mg/kg | Experimental | 6 doses of MOR103 2.0 mg/kg administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6). |
|
| Placebo | Placebo Comparator | 6 doses of placebo administered on Days 1 (Baseline), 15 (Visit 2), 29 (Visit 3), 43 (Visit 4), 57 (Visit 5), and 71 (Visit 6). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MOR103 | Biological | Anti-GM-CSF monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) | The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1 | From the first dose (week 0) to study endpoint (week 20) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples | To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies. | Baseline, week 14, week 16, and week 20/end of study |
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Key Inclusion Criteria:
Outpatients with a diagnosis of RRMS or SPMS, who are currently not being treated and who have at least 1 of the following:
The patient must be able and willing to ambulate, with an Expanded Disability Status Scale (EDSS) score of ≥ 2.0 and ≤ 6.5 at both the Screening Visit and the Baseline Visit
Key Exclusion Criteria:
A patient with primary progressive MS (PPMS)
A patient who has previously received at any time any of the following
A patient who has not stabilized, in the opinion of the investigator
A patient with any medical condition or uncontrolled disease states other than MS requiring or likely to require systemic treatment with corticosteroids or other immune compromising agents
A patient with current or a history of major chronic inflammatory autoimmune diseases other than MS
A patient with any type of infection
Patients on chronic prophylactic or suppressive antibiotic, antifungal,or antiviral agents
A patient with a history of tuberculosis.
A patient with any signs of excretory hepatic or kidney dysfunction
A patient with a positive test for Hepatitis B or Hepatitis C
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| Name | Affiliation | Role |
|---|---|---|
| Roman P Korolkiewicz, MD, PhD | MorphoSys AG | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morphosys Investigative Site | Berlin | Germany | ||||
| Morphosys Investigative Site |
Not provided
Subjects were recruited and screened between 2 January 2012 and 22 July 2013 at 5 trial centers in Europe (1 in Germany, 2 in Poland, and 2 in the United Kingdom). Screening could occur between 10 and 35 days prior to dosing on day 1. Subject eligibility was determined at the screening visit and confirmed before the first dose on day 1.
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| ID | Title | Description |
|---|---|---|
| FG000 | MOR103 0.5 mg/kg | MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| FG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| FG002 | MOR103 2.0 mg/kg | MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| FG003 | Pooled Placebo | Placebo administered intravenously once every 2 weeks for a total of 6 doses |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All subjects who received 1 or more dose of placebo or MOR103 (safety population).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MOR103 0.5 mg/kg | MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| BG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| 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 | Percentages of Patients With Treatment-emergent Adverse Events (TEAEs) or Treatment-emergent Serious Adverse Events (TESAEs) | The safety of multiple doses of MOR103 in patients with relapsing-remitting or secondary progressive multiple sclerosis (MS) was assessed by evaluation of the incidence of TEAEs and TESAEs. A full listing of adverse events recorded during this trial can be found in the Adverse Events section. AEs were regarded as treatment emergent if they started on or after the first date of study drug administration or if they were present prior to the first date of study drug administration and increased in severity or relationship to study drug during the study. AEs were coded using MedDRA version 16.1 | All subjects who received 1 or more dose of placebo or MOR103 (safety population). | Posted | Number | percentage of participants | From the first dose (week 0) to study endpoint (week 20) |
|
From first dose of study medication to last visit (week 20)
Patients were examined for adverse events (AEs) at all study visits. Data for treatment-emergent AEs (AEs occurring or worsening after the first dose of medication) are presented here.
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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 | MOR103 0.5 mg/kg | MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo | Ear and labyrinth disorders | MedDRA 16.1 | Systematic Assessment |
Key limitations of this trial include its small sample size and limited duration. Efficacy assessments were not made in this study. Larger clinical trials will be required to evaluate the potential of MOR103 in treating patients with MS.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roman Korolkiewicz | MorphoSys | +49 89 89927 208 | roman.korolkiewicz@morphosys.com |
Not provided
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| C000599766 | Otilimab |
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| Placebo | Other | Placebo to anti-GM-CSF monoclonal antibody |
|
| Mean Serum Concentration of MOR103 Over Time | MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit. | Week 0 (dose 1) to week 20 (end of study) |
| Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses | At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax. | Week 0 (first dose) and week 10 (last dose) |
| Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses | At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable. | Week 0 (first dose) and week 10 (last dose) |
| Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC | At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable. | Week 0 (first dose) and week 10 (last dose) |
| Number of New T1 Gadolinium-enhancing Lesions | Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany). | Week 4, week 8, week 12, and week 16. |
| Number of New or Enlarging T2 Lesions | T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany). | Week 8, week 12, and week 16. |
| Gdansk |
| Poland |
| Morphosys Investigative Site | Poznan | Poland |
| Morhosys Investigative Site | Manchester | United Kingdom |
| MorphoSys Investigative Site | Nottingham | United Kingdom |
| Physician Decision |
|
| BG002 | MOR103 2.0 mg/kg | MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| BG003 | Pooled Placebo | Placebo administered intravenously once every 2 weeks for a total of 6 doses |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Diagnosis | Number | participants |
|
| Time since diagnosis | Mean | Standard Deviation | years |
|
| Gadolinium (Gd)-enhancing lesions | Number | participants |
|
MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
| OG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| OG002 | MOR103 2.0 mg/kg | MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. |
| OG003 | Pooled Placebo | Placebo administered intravenously once every 2 weeks for a total of 6 doses |
|
|
| Secondary | Percentages of Patients Negative for Anti-MOR103 Antibodies in Serum Samples | To assess the potential immunogenicity of MOR103, a central bioanalytical laboratory (Eurofins Medinet BV, Breda, The Netherlands) tested serum samples obtained at baseline and at 3 post-treatment time points (week 14, week 16, and week 20/end of study) for anti-MOR103 antibodies. | All subjects who received 1 or more dose of placebo or MOR103 (safety population). Data were missing for 1 patient each in the MOR103 1.0 mg/kg and 2.0 mg/kg groups at week 14 and week 16. Data were also missing for 1 patient in the placebo group at all post-baseline timepoints (week 14, 16, and 20). | Posted | Number | percentage of participants | Baseline, week 14, week 16, and week 20/end of study |
|
|
|
| Secondary | Mean Serum Concentration of MOR103 Over Time | MOR103 serum levels were measured at each visit. At all visits during the dosing period (weeks 0, 2, 6, 8, and 10), serum samples were taken before MOR103 administration (pre-dose) and 1 hour after the dose. In addition, at week 0 (first dose) and week 10 (last dose), additional samples were obtained at 2 hours and 4 hours after MOR103 administration. At visits that followed the dosing period (weeks 12, 14, 16, and 20), a single serum sample was obtained at any time during the visit. | Pharmacokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data were not available for all patients at each time point. | Posted | Mean | Standard Deviation | mg/L | Week 0 (dose 1) to week 20 (end of study) |
|
|
|
| Secondary | Mean Maximum MOR103 Concentration (Cmax) After the First and Last MOR103 Doses | At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Cmax values for each patient were calculated based on these data, and the mean Cmax values for the dose cohort are presented here. Because Cmax refers to the maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable, as they represent the concentration of MOR103, but not the Cmax. | Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7). | Posted | Mean | Standard Deviation | mg/L | Week 0 (first dose) and week 10 (last dose) |
|
|
|
| Secondary | Mean Time to Maximum MOR103 Concentration (Tmax) After the First and Last MOR103 Doses | At the week 0 (first dose) and week 10 (last dose) visits, serum samples were obtained at pre-dose and at 1, 2, and 4 hours after the dose. Tmax values for each patient were calculated based on these data, and the mean Tmax values for the dose cohort are presented here. Because Tmax refers to the time to maximum serum concentration, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable. | Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). PK data for the last dose were missing for one patient in the MOR103 2.0 mg/kg group (n = 7). | Posted | Mean | Standard Deviation | hour | Week 0 (first dose) and week 10 (last dose) |
|
|
|
| Secondary | Accumulation Ratio for Area Under the MOR103 Serum Concentration Versus Time Curve (AUC) Over One Dosing Interval: Ratio of Week 10 (Last Dose) AUC to Week 0 (First Dose) AUC | At week 0 (first dose) and week 10 (last dose), serum samples were obtained at pre-dose and at 1, 2, 4, and 336 hours after start of dosing. To calculate the accumulation ratio, the apparent AUC calculated for the last dose was divided by the apparent AUC following the first dose using the described time points for each dosing. Because AUC is a summary outcome, only one value is presented for each dose cohort on each day; values at each PK time point are not applicable. | Pharmocokinetic (PK) analyses were conducted on the PK set, which included all MOR103-treated patients except for 2 patients who discontinued after 2 doses of trial medication (one each in the 1.0 and 2.0 mg/kg groups). Data were missing for one patient in the MOR103 2.0 mg/kg group (n = 7). | Posted | Mean | Standard Deviation | ratio of AUC values | Week 0 (first dose) and week 10 (last dose) |
|
|
|
| Secondary | Number of New T1 Gadolinium-enhancing Lesions | Magnetic resonance imaging (MRI) tests were performed at screening (to confirm subject eligibility) and at Weeks 4, 8, 2, and 16. MRIs at post-screening time points were used to assess the number of new lesions as revealed by gadolinium (Gd) enhancement. Gd-enhanced MRIs reveal new brain lesions reflecting areas of active inflammation. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany). | MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 4, 8, 12, and 16 were: MOR103 0.5 mg/kg: 8,8,8,8 MOR103 1.0 m/kg: 6,6,6,6 MOR103 2.0 mg/kg: 8,7,7,7 Placebo: 6, 6, 4, 5 | Posted | Number | Number of new T1 Gd-enhancing lesions | Week 4, week 8, week 12, and week 16. |
|
|
|
| Secondary | Number of New or Enlarging T2 Lesions | T2-weighted magnetic resonance imaging (MRI) tests were performed at Weeks 8, 12, and 16 to assess the number of new or enlarging T2 brain lesions, a sign of MS activity. MRI images were assessed centrally by Synarc A/S (Hamburg, Germany). | MRIs were performed in the safety population (all patients who received at least 1 dose of MOR103 or placebo). However, MRIs at Weeks 12 and 16 were not mandatory per protocol. The number of patients evaluated at Weeks 8, 12, and 16 were: MOR103 0.5 mg/kg: 8,8,8 MOR103 1.0 m/kg: 6,6,6 MOR103 2.0 mg/kg: 7,7,7 Placebo: 6, 4, 5 | Posted | Number | Number of new or enlarging T2 lesions | Week 8, week 12, and week 16. |
|
|
|
| 0 |
| 8 |
| 8 |
| 8 |
| EG001 | MOR103 1.0 mg/kg | MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. | 1 | 8 | 8 | 8 |
| EG002 | MOR103 2.0 mg/kg | MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses. | 0 | 9 | 8 | 9 |
| EG003 | Pooled Placebo | Placebo administered intravenously once every 2 weeks for a total of 6 doses | 1 | 6 | 6 | 6 |
| Cataract | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA 16.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oesophageal pain | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Feeling of body temperature change | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Influenza-like illness | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Urethral injury | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood cholesterol increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood creatinine phosphokinase increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| C-reactive protein increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Carbon monoxide diffusing capacity decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Hemoglobin urine present | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Hysteroscopy | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Lymphocyte count increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Nuclear magnetic resonance imaging abnormal | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Peak expiratory flow rate decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Red blood cells urine positive | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 16.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cerebellar syndrome | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Decreased vibratory sense | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Multiple sclerosis relapse | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Paresthesia | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sensory disturbance | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus headache | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 16.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Mental disorder due to a general medical condition | Psychiatric disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA 16.1 | Systematic Assessment |
|
| Menopausal symptoms | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Postmenopausal hemorrhage | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 16.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Rhinalgia | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
|
| Intra-uterine contraceptive device | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Intra-uterine contraceptive device removal | Surgical and medical procedures | MedDRA 16.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 16.1 | Systematic Assessment |
|
All information supplied by MorphoSys is considered confidential until publication and shall not be disclosed without prior written consent from MorphoSys. No data can be published in any format without prior approval of MorphoSys, which has final decision on approving submissions for publication. In the event of disagreement in the content of a publication, both the Author's and MorphoSys' opinion will be fairly and sufficiently represented in the publication.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Week 14 |
|
| Week 16 |
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| Week 20 |
|
|
| Week 0: 2 hours after 1st dose |
|
| Week 0: 4 hours after 1st dose |
|
| Week 2: Pre-dose |
|
| Week 2: 1 hour after 2nd dose |
|
| Week 4: Pre-dose |
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| Week 4: 1 hour after 3rd dose |
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| Week 6: Pre-dose |
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| Week 6: 1 hour after 4th dose |
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| Week 8: Pre-dose |
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| Week 8: 1 hour after 5th dose |
|
| Week 10: Pre-dose |
|
| Week 10: 1 hour after 6th and last dose |
|
| Week 10: 2 hours after 6th and last dose |
|
| Week 10: 4 hours after 6th and last dose |
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| Week 12 |
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| Week 14 |
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| Week 16 |
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| Week 20 |
|
|
|
| Week 8 |
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| Week 12 |
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| Week 16 |
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| Week 12 |
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| Week 16 |
|