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| ID | Type | Description | Link |
|---|---|---|---|
| Earth Explorer X | Other Identifier | MedImmune |
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The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
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A clinical study to investigate the safety of mavrilimumab, an antibody being developed for the treatment of moderate to severe rheumatoid arthritis, an inflammatory condition that affects the joints.
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still a significant unmet medical need for the treatment of subjects with this chronic disease to achieve a faster, more complete response, and higher rates of remission. This study is an open-label extension study for subjects who have participated in one of the qualifying development program studies with mavrilimumab. Participation in this study will allow these subjects to continue to receive long-term treatment with mavrilimumab. The data from this study will provide an evaluation of the long-term safety of mavrilimumab in adult subjects with RA. In addition, long-term exploratory efficacy outcomes such as joint damage and disability will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mavrilimumab 100 mg | Experimental | Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavrilimumab 100 mg | Biological | Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
| Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
| Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
| Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. |
Not provided
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ciudad Autonoma Buenos Aires | Argentina | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29361199 | Derived | Burmester GR, McInnes IB, Kremer JM, Miranda P, Vencovsky J, Godwood A, Albulescu M, Michaels MA, Guo X, Close D, Weinblatt M. Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor alpha Monoclonal Antibody: Long-Term Safety and Efficacy in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2018 May;70(5):679-689. doi: 10.1002/art.40420. Epub 2018 Mar 31. |
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A total of 442 participants who received at least one dose of mavrilimumab provided a pooled analysis of safety and efficacy data from this open-label extension study (CD-IA-CAM-3001-1109) together with the qualifying studies (CD IA CAM 3001 1071 and CD IA CAM 3001 1107).
A total of 409 participants consented and 397 participants received mavrilimumab in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mavrilimumab 100 mg | Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
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| From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
| Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | From Week 24 to Week 130 at specified time points |
| Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | From Week 24 to Week 130 at specified time points |
| Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | From Week 24 to Week 156 at specified time points |
| Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing. | From Week 0 to Week 132 at specified time points |
| Oxygen Saturation Levels by Pulse Oximetry | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. | From Week 0 to Week 132 at specified time points |
| Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide. | From Week 12 to Week 156 at specified time points |
| Ciudad Autonoma de Buenos Aire |
| Argentina |
| Research Site | Rosario | Argentina |
| Research Site | San Miguel de Tucumán | Argentina |
| Research Site | Plovdiv | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Santiago | Chile |
| Research Site | Viña del Mar | Chile |
| Research Site | Barranquilla | Colombia |
| Research Site | Bruntál | Czechia |
| Research Site | Jihlava | Czechia |
| Research Site | Ostrava - Trebovice | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Uherské Hradiště | Czechia |
| Research Site | Zlín | Czechia |
| Research Site | Tallinn | Estonia |
| Research Site | Cologne | Germany |
| Research Site | Magdeburg | Germany |
| Research Site | Athens | Greece |
| Research Site | Larissa | Greece |
| Research Site | Baja | Hungary |
| Research Site | Balatonfüred | Hungary |
| Research Site | Budapest | Hungary |
| Research Site | Debrecen | Hungary |
| Research Site | Ashkelon | Israel |
| Research Site | Kfar Saba | Israel |
| Research Site | Petah Tikva | Israel |
| Research Site | Mérida | Mexico |
| Research Site | Gdynia | Poland |
| Research Site | Grodzisk Mazowiecki | Poland |
| Research Site | Katowice | Poland |
| Research Site | Krakow | Poland |
| Research Site | Wroclaw | Poland |
| Research Site | Barnaul | Russia |
| Research Site | Kazan' | Russia |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Yaroslavl | Russia |
| Research Site | Belgrade | Serbia |
| Research Site | Niška Banja | Serbia |
| Research Site | Bratislava | Slovakia |
| Research Site | Durban | South Africa |
| Research Site | Barcelona | Spain |
| Research Site | Málaga | Spain |
| Research Site | Santiago de Compostela | Spain |
| Research Site | Donetsk | Ukraine |
| Research Site | Kharkiv | Ukraine |
| Research Site | Kiev | Ukraine |
| Research Site | Lutsk | Ukraine |
| Research Site | Vinnytsia | Ukraine |
| Research Site | Edinburgh | United Kingdom |
| Research Site | London | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg every 2 weeks (Q2W).
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mavrilimumab 100 mg | Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | Participants |
| |||||||||||||||||||||||
| Weight | Mean | Standard Deviation | Kilogram |
|
| 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 Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received investigational product. A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Posted | Number | Participants | From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Laboratory parameters included hematology, serum chemistry and urinalysis recorded as TEAEs. Clinical laboratory abnormalities recorded as TEAEs were reported.TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Posted | Number | Participants | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) | Vital sign assessments included blood pressure, pulse rate, temperature, weight and respiration rate. Vital sign abnormalities recorded as TEAEs were reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Posted | Number | Participants | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs | The 12-lead ECG data were summarized and evaluated. TEAEs related to abnormal ECG findings were recorded and reported. TEAEs were defined as AEs with onset date after the first dose of mavrilimumab 100 mg. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Posted | Number | Participants | From the start of study drug administration in the study up to 12 weeks after the last dose of study drug (approximately up to 3 years) |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 1 second (FEV1). FEV1 was the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration.The percentage (%) of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as less than or equal to (=<)15% reduction from baseline, greater than (>)15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | From Week 24 to Week 130 at specified time points |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced expiratory volume in 6 seconds (FEV6). FEV6 was the maximal volume of air exhaled in the six second of a forced expiration from a position of full inspiration. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | From Week 24 to Week 130 at specified time points |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values | Pulmonary function testing was performed by spirometry to assess forced vital capacity (FVC). FVC was the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. The percentage of predicted values of these pulmonary function tests were calculated based on decrease from baseline and categorized as =<15% reduction from baseline, >15% to =<20% reduction from baseline, >20% reduction from baseline and >20% reduction to <80%. The threshold values refer to baseline values for each participant. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Posted | Number | Participants | From Week 24 to Week 156 at specified time points |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE | Borg dyspnea score was a validated participant reported outcome assessing participant's perceived difficulty in breathing (dyspnea). The score ranges from 0 (nothing at all) to 10 (maximal difficulty). Higher scores indicated greater difficulty in breathing. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. | Posted | Number | Participants | From Week 0 to Week 132 at specified time points |
|
| ||||||||||||||||||||||||||||||||||
| Primary | Oxygen Saturation Levels by Pulse Oximetry | Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Error | Percent saturation | From Week 0 to Week 132 at specified time points |
|
| |||||||||||||||||||||||||||||||||
| Primary | Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) | DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide. | The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W. Here 'n' represents those participants who were evaluable for this measure at given time points. | Posted | Mean | Standard Deviation | (mL/min/mmHg) | From Week 12 to Week 156 at specified time points |
|
|
From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Not provided
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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 | Mavrilimumab 100 mg | Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years. | 46 | 397 | 214 | 397 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cardiopulmonary failure | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Colitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendiceal abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis perforated | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Peritonitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pulmonary tuberculosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pyomyositis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sialoadenitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ligament rupture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Foot deformity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Breast cancer female | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Fibroadenoma of breast | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Pyogenic granuloma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Myelitis transverse | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cervical dysplasia | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Ovarian cyst | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Peripheral artery thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Subclavian artery thrombosis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dental caries | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
MedImmune has 60 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome. The PIs also agree for data to be presented first as a joint, multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marius Albulescu, MD | MedImmune, LLC. | 301-398-0000 | clinicaltrialenquiries@medimmune.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C561644 | mavrilimumab |
Not provided
Not provided
Not provided
| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White |
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| Other |
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| CHILE |
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| COLOMBIA |
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| CZECH REPUBLIC |
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| ESTONIA |
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| GERMANY |
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| GREECE |
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| HUNGARY |
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| ISRAEL |
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| MEXICO |
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| RUSSIAN FEDERATION |
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| SERBIA |
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| SLOVAKIA |
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| SOUTH AFRICA |
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| SPAIN |
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| UKRAINE |
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| UNITED KINGDOM |
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