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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

Tracking Information
First Submitted Date  ICMJE October 19, 2012
First Posted Date  ICMJE October 23, 2012
Results First Submitted Date  ICMJE February 28, 2017
Results First Posted Date  ICMJE June 1, 2017
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE January 28, 2013
Actual Primary Completion Date December 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 30, 2017)
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) [ 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) ]
    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.
  • Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [ 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) ]
    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.
  • Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs) [ 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) ]
    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.
  • Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs [ 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) ]
    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.
  • Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values [ Time Frame: From Week 24 to Week 130 at specified time points ]
    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.
  • Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values [ Time Frame: From Week 24 to Week 130 at specified time points ]
    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.
  • Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values [ Time Frame: From Week 24 to Week 156 at specified time points ]
    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.
  • Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE [ Time Frame: From Week 0 to Week 132 at specified time points ]
    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.
  • Oxygen Saturation Levels by Pulse Oximetry [ Time Frame: From Week 0 to Week 132 at specified time points ]
    Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
  • Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [ Time Frame: From Week 12 to Week 156 at specified time points ]
    DLCO is a pulmonary function testing that measures partial pressure difference between inspired and expired carbon monoxide.
Original Primary Outcome Measures  ICMJE
 (submitted: October 19, 2012)
  • Safety and Tolerability [ Time Frame: Informed consent through to approximately 5 year total ]
    The occurrence of AEs and SAEs
  • Safety and Tolerability [ Time Frame: Various timepoints from Day 1 through to approximately 5 years ]
    Vital sign measurements - blood pressure, heart rate, temperature, respiratory rate
  • Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ]
    Clinical lab measurements - chemistry and hematology
  • Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ]
    Pulmonary function tests and dyspnoea score
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Official Title  ICMJE An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE Biological: Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Study Arms  ICMJE Experimental: Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Intervention: Biological: Mavrilimumab 100 mg
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 1, 2016)
409
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2012)
400
Actual Study Completion Date  ICMJE December 30, 2015
Actual Primary Completion Date December 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects who have completed the treatment period of the qualifying study or will have failed to respond adequately to investigational product at a predefined time point in the qualifying study regardless of their initial randomization.
  • No evidence of clinically uncontrolled respiratory disease to be confirmed by a local pulmonologist

Exclusion Criteria:

  • Subjects who have been permanently discontinued from investigational product in previous qualifying study.
  • Any new conditions or worsening of any pre-existing conditions as defined in the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Bulgaria,   Chile,   Colombia,   Czechia,   Estonia,   Germany,   Greece,   Hungary,   Israel,   Mexico,   Poland,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Ukraine,   United Kingdom
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01712399
Other Study ID Numbers  ICMJE CD-IA-CAM-3001-1109
Earth Explorer X ( Other Identifier: MedImmune )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party MedImmune LLC
Original Responsible Party Same as current
Current Study Sponsor  ICMJE MedImmune LLC
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account MedImmune LLC
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP