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A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01712399
Recruitment Status : Terminated (The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.)
First Posted : October 23, 2012
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Intervention Biological: Mavrilimumab 100 mg
Enrollment 409
Recruitment Details A total of 409 participants consented and 397 participants received mavrilimumab in this study.
Pre-assignment Details 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).
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Period Title: Overall Study
Started 397
Completed 0
Not Completed 397
Reason Not Completed
Lost to Follow-up             1
Withdrawal by Subject             39
Death             1
Adverse Event             11
Study closure             345
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Baseline Participants 397
Hide Baseline Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg every 2 weeks (Q2W).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 397 participants
51.1  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 397 participants
Female
339
  85.4%
Male
58
  14.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 397 participants
American Indian or Alaskan Native 29
Asian 1
Black or African American 1
Native Hawaiian or Other Pacific Islander 0
White 364
Other 2
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 397 participants
ARGENTINA 41
BULGARIA 3
CHILE 35
COLOMBIA 25
CZECH REPUBLIC 69
ESTONIA 21
GERMANY 8
GREECE 3
HUNGARY 9
ISRAEL 11
MEXICO 10
POLAND 34
RUSSIAN FEDERATION 53
SERBIA 24
SLOVAKIA 1
SOUTH AFRICA 2
SPAIN 4
UKRAINE 39
UNITED KINGDOM 5
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 397 participants
73.25  (16.40)
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Hide Description 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.
Time Frame From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
TEAEs 288
TESAEs 46
2.Primary Outcome
Title Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
Anaemia 8
Eosinophilia 1
Iron deficiency anaemia 2
Leukocytosis 1
Leukopenia 1
Lymphadenopathy 1
Neutropenia 2
Spontaneous haematoma 1
Alanine aminotransferase increased 8
Aspartate aminotransferase increased 6
Blood creatinine increased 1
Blood glucose increased 1
Blood pressure increased 3
C-reactive protein increased 1
Chest X-ray abnormal 1
Forced vital capacity abnormal 1
Gamma-glutamyltransferase increased 2
Hepatic enzyme increased 2
Liver function test abnormal 1
Mycobacterium tuberculosis complex test positive 1
Neutrophil count decreased 1
Red blood cell sedimentation rate increased 1
Transaminases increased 3
Diabetes mellitus 5
Dyslipidaemia 4
Hypercholesterolaemia 9
Hyperglycaemia 3
Hyperlipidaemia 2
Hypertriglyceridaemia 2
Hypoglycaemia 1
Type 2 diabetes mellitus 4
3.Primary Outcome
Title Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
Hypertension 26
Pyrexia 3
Blood pressure increased 3
Atrial fibrillation 1
Palpitations 1
Sinus tachycardia 1
4.Primary Outcome
Title Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
0
5.Primary Outcome
Title Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
Hide Description 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.
Time Frame From Week 24 to Week 130 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
Week 24:=<15% reduction Number Analyzed 236 participants
208
Week 24:>15% to =<20% Number Analyzed 236 participants
12
Week 24:>20% reduction Number Analyzed 236 participants
16
Week 24:>20% to <80% Number Analyzed 236 participants
13
Week 48:=<15% reduction Number Analyzed 231 participants
208
Week 48: >15% to =<20% Number Analyzed 231 participants
10
Week 48: >20% reduction Number Analyzed 231 participants
13
Week 48:>20% to <80% Number Analyzed 231 participants
8
Week 78:=<15% reduction Number Analyzed 178 participants
154
Week 78:>15% to =<20% Number Analyzed 178 participants
8
Week 78:>20% reduction Number Analyzed 178 participants
16
Week 78:>20% to <80% Number Analyzed 178 participants
11
Week 104:=<15% reduction Number Analyzed 29 participants
28
Week 104:>15% to =<20% Number Analyzed 29 participants
0
Week 104:>20% reduction Number Analyzed 29 participants
1
Week 104:>20% to <80% Number Analyzed 29 participants
1
Week 130:=<15% reduction Number Analyzed 3 participants
3
Week 130:>15% to =<20% Number Analyzed 3 participants
0
Week 130:>20% reduction Number Analyzed 3 participants
0
Week 130:>20% to <80% Number Analyzed 3 participants
0
6.Primary Outcome
Title Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
Hide Description 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.
Time Frame From Week 24 to Week 130 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
Week 24:=<15% reduction Number Analyzed 222 participants
195
Week 24:>15% to =<20% Number Analyzed 222 participants
14
Week 24:>20% reduction Number Analyzed 222 participants
13
Week 24:>20% to <80% Number Analyzed 222 participants
9
Week 48:=<15% reduction Number Analyzed 222 participants
201
Week 48:>15% to =<20% Number Analyzed 222 participants
13
Week 48:>20% reduction Number Analyzed 222 participants
8
Week 48:>20% to <80% Number Analyzed 222 participants
4
Week 78:=<15% reduction Number Analyzed 172 participants
150
Week 78:>15% to =<20% Number Analyzed 172 participants
8
Week 78:>20% reduction Number Analyzed 172 participants
14
Week 78:>20% to <80% Number Analyzed 172 participants
5
Week 104:=<15% reduction Number Analyzed 28 participants
27
Week 104:>15% to =<20% Number Analyzed 28 participants
0
Week 104:>20% reduction Number Analyzed 28 participants
1
Week 104:>20% to <80% Number Analyzed 28 participants
1
Week 130:=<15% reduction Number Analyzed 3 participants
1
Week 130:>15% to =<20% Number Analyzed 3 participants
0
Week 130:>20% reduction Number Analyzed 3 participants
2
Week 130:>20% to <80% Number Analyzed 3 participants
2
7.Primary Outcome
Title Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
Hide Description 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.
Time Frame From Week 24 to Week 156 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Measure Type: Number
Unit of Measure: Participants
Week 24 :=<15% reduction Number Analyzed 233 participants
209
Week 24:>15% to =<20% Number Analyzed 233 participants
13
Week 24:>20% reduction Number Analyzed 233 participants
11
Week 24:>20% to <80% Number Analyzed 233 participants
7
Week 48:=<15% reduction Number Analyzed 239 participants
218
Week 48:>15% to =<20% Number Analyzed 239 participants
10
Week 48:>20% reduction Number Analyzed 239 participants
11
Week 48:>20% to <80% Number Analyzed 239 participants
7
Week 78:=<15% reduction Number Analyzed 177 participants
160
Week 78:>15% to =<20% Number Analyzed 177 participants
4
Week 78:>20% reduction Number Analyzed 177 participants
13
Week 78:>20% to <80% Number Analyzed 177 participants
6
Week 104:=<15% reduction Number Analyzed 32 participants
32
Week 104:>15% to =<20% Number Analyzed 32 participants
0
Week 104:>20% reduction Number Analyzed 32 participants
0
Week 104:>20% to <80% Number Analyzed 32 participants
0
Week 130:=<15% reduction Number Analyzed 5 participants
4
Week 130:>15% to =<20% Number Analyzed 5 participants
0
Week 130:>20% reduction Number Analyzed 5 participants
1
Week 130:>20% to <80% Number Analyzed 5 participants
1
Week 156:=<15% reduction Number Analyzed 2 participants
2
Week 156:>15% to =<20% Number Analyzed 2 participants
0
Week 156:>20% reduction Number Analyzed 2 participants
0
Week 156:>20% to <80% Number Analyzed 2 participants
0
8.Primary Outcome
Title Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
Hide Description 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.
Time Frame From Week 0 to Week 132 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
The As-treated Population included participants who received at least one dose of mavrilimumab 100 mg Q2W.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 394
Measure Type: Number
Unit of Measure: Participants
0
9.Primary Outcome
Title Oxygen Saturation Levels by Pulse Oximetry
Hide Description Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
Time Frame From Week 0 to Week 132 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Mean (Standard Error)
Unit of Measure: Percent saturation
Week 0 (n=397) Number Analyzed 397 participants
97.6  (0.1)
Week 12 (n=384) Number Analyzed 384 participants
97.6  (0.1)
Week 24 (n=1) Number Analyzed 1 participants
98.0 [1]   (NA)
Week 36 (n=357) Number Analyzed 357 participants
97.5  (0.1)
Week 48 (n=327) Number Analyzed 327 participants
97.8  (0.1)
Week 60 (n=281) Number Analyzed 281 participants
97.8  (0.1)
Week 72 (n=233) Number Analyzed 233 participants
97.7  (0.1)
Week 84 (n=222) Number Analyzed 222 participants
97.7  (0.1)
Week 96 (n=188) Number Analyzed 188 participants
97.9  (0.1)
Week 108 (n=58) Number Analyzed 58 participants
97.8  (0.2)
Week 120 (n=18) Number Analyzed 18 participants
97.6  (0.3)
Week 132 (n=7) Number Analyzed 7 participants
97.9  (0.5)
[1]
Standard error was not calculated due to limited sample size.
10.Primary Outcome
Title Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
Hide Description DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Time Frame From Week 12 to Week 156 at specified time points
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description:
Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Overall Number of Participants Analyzed 397
Mean (Standard Deviation)
Unit of Measure: (mL/min/mmHg)
Week 12 (n=80) Number Analyzed 80 participants
21.196  (5.158)
Week 24 (n=155) Number Analyzed 155 participants
21.996  (5.274)
Week 48 (n=203) Number Analyzed 203 participants
21.135  (4.873)
Week 78 (n=165) Number Analyzed 165 participants
20.639  (4.637)
Week 104 (n=144) Number Analyzed 144 participants
20.636  (5.088)
Week 130 (n=52) Number Analyzed 52 participants
20.372  (4.546)
Week 156 (n=6) Number Analyzed 6 participants
19.265  (4.131)
Time Frame From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mavrilimumab 100 mg
Hide Arm/Group Description Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
All-Cause Mortality
Mavrilimumab 100 mg
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Mavrilimumab 100 mg
Affected / at Risk (%) # Events
Total   46/397 (11.59%)    
Blood and lymphatic system disorders   
Anaemia  1  3/397 (0.76%)  3
Neutropenia  1  1/397 (0.25%)  1
Cardiac disorders   
Cardiopulmonary failure  1  2/397 (0.50%)  2
Myocardial infarction  1  2/397 (0.50%)  2
Gastrointestinal disorders   
Colitis  1  1/397 (0.25%)  1
Pancreatitis acute  1  1/397 (0.25%)  1
Hepatobiliary disorders   
Cholecystitis acute  1  1/397 (0.25%)  1
Cholelithiasis  1  1/397 (0.25%)  1
Infections and infestations   
Appendiceal abscess  1  1/397 (0.25%)  1
Appendicitis perforated  1  1/397 (0.25%)  1
Bronchitis  1  4/397 (1.01%)  4
Diverticulitis  1  1/397 (0.25%)  1
Gastroenteritis  1  2/397 (0.50%)  2
Peritonitis  1  1/397 (0.25%)  1
Pneumonia  1  1/397 (0.25%)  1
Pulmonary tuberculosis  1  2/397 (0.50%)  2
Pyomyositis  1  1/397 (0.25%)  1
Sialoadenitis  1  1/397 (0.25%)  1
Urinary tract infection  1  2/397 (0.50%)  2
Injury, poisoning and procedural complications   
Ankle fracture  1  1/397 (0.25%)  1
Femoral neck fracture  1  1/397 (0.25%)  1
Humerus fracture  1  1/397 (0.25%)  1
Ligament rupture  1  1/397 (0.25%)  1
Ligament sprain  1  1/397 (0.25%)  1
Upper limb fracture  1  1/397 (0.25%)  1
Musculoskeletal and connective tissue disorders   
Foot deformity  1  1/397 (0.25%)  1
Osteoarthritis  1  2/397 (0.50%)  3
Rheumatoid arthritis  1  4/397 (1.01%)  5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Breast cancer female  1  1/397 (0.25%)  1
Fibroadenoma of breast  1  1/397 (0.25%)  1
Invasive ductal breast carcinoma  1  1/397 (0.25%)  1
Pyogenic granuloma  1  1/397 (0.25%)  1
Uterine leiomyoma  1  2/397 (0.50%)  2
Nervous system disorders   
Myelitis transverse  1  1/397 (0.25%)  1
Syncope  1  1/397 (0.25%)  1
Reproductive system and breast disorders   
Cervical dysplasia  1  1/397 (0.25%)  1
Ovarian cyst  1  1/397 (0.25%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnoea  1  1/397 (0.25%)  1
Vascular disorders   
Peripheral arterial occlusive disease  1  1/397 (0.25%)  1
Peripheral artery stenosis  1  1/397 (0.25%)  1
Peripheral artery thrombosis  1  1/397 (0.25%)  2
Subclavian artery thrombosis  1  1/397 (0.25%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Mavrilimumab 100 mg
Affected / at Risk (%) # Events
Total   214/397 (53.90%)    
Gastrointestinal disorders   
Dental caries  1  8/397 (2.02%)  9
Diarrhoea  1  15/397 (3.78%)  15
Infections and infestations   
Bronchitis  1  44/397 (11.08%)  59
Gastroenteritis  1  11/397 (2.77%)  14
Influenza  1  23/397 (5.79%)  26
Nasopharyngitis  1  59/397 (14.86%)  90
Oral herpes  1  11/397 (2.77%)  13
Pharyngitis  1  18/397 (4.53%)  20
Respiratory tract infection  1  13/397 (3.27%)  21
Rhinitis  1  9/397 (2.27%)  10
Upper respiratory tract infection  1  31/397 (7.81%)  43
Urinary tract infection  1  35/397 (8.82%)  53
Viral infection  1  8/397 (2.02%)  10
Injury, poisoning and procedural complications   
Fall  1  8/397 (2.02%)  8
Investigations   
Alanine aminotransferase increased  1  8/397 (2.02%)  8
Metabolism and nutrition disorders   
Hypercholesterolaemia  1  9/397 (2.27%)  9
Musculoskeletal and connective tissue disorders   
Back pain  1  12/397 (3.02%)  13
Osteoarthritis  1  12/397 (3.02%)  13
Rheumatoid arthritis  1  38/397 (9.57%)  78
Nervous system disorders   
Headache  1  17/397 (4.28%)  35
Respiratory, thoracic and mediastinal disorders   
Cough  1  8/397 (2.02%)  9
Vascular disorders   
Hypertension  1  26/397 (6.55%)  27
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.1
The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Marius Albulescu, MD
Organization: MedImmune, LLC.
Phone: 301-398-0000
EMail: clinicaltrialenquiries@medimmune.com
Layout table for additonal information
Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01712399    
Other Study ID Numbers: CD-IA-CAM-3001-1109
Earth Explorer X ( Other Identifier: MedImmune )
First Submitted: October 19, 2012
First Posted: October 23, 2012
Results First Submitted: February 28, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017