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

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Mavrilimumab 100 mg
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mavrilimumab 100 mg

Arm Description

Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
Oxygen Saturation Levels by Pulse Oximetry
Oxygen saturation measured by pulse oximetry which measures the concentration of oxygen in the blood.
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.

Secondary Outcome Measures

Full Information

First Posted
October 19, 2012
Last Updated
May 30, 2017
Sponsor
MedImmune LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01712399
Brief Title
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Official Title
An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.
Study Start Date
January 28, 2013 (undefined)
Primary Completion Date
December 30, 2015 (Actual)
Study Completion Date
December 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedImmune LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
409 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mavrilimumab 100 mg
Arm Type
Experimental
Arm Description
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Intervention Type
Biological
Intervention Name(s)
Mavrilimumab 100 mg
Intervention Description
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
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)
Title
Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
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)
Title
Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
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)
Title
Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
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)
Title
Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
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
Title
Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
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
Title
Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
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
Title
Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
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
Title
Oxygen Saturation Levels by Pulse Oximetry
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
Title
Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Research Site
City
Ciudad Autonoma Buenos Aires
Country
Argentina
Facility Name
Research Site
City
Ciudad Autonoma de Buenos Aire
Country
Argentina
Facility Name
Research Site
City
Rosario
Country
Argentina
Facility Name
Research Site
City
San Miguel de Tucuman
Country
Argentina
Facility Name
Research Site
City
Plovdiv
Country
Bulgaria
Facility Name
Research Site
City
Sofia
Country
Bulgaria
Facility Name
Research Site
City
Santiago
Country
Chile
Facility Name
Research Site
City
Vina del Mar
Country
Chile
Facility Name
Research Site
City
Barranquilla
Country
Colombia
Facility Name
Research Site
City
Bruntal
Country
Czechia
Facility Name
Research Site
City
Jihlava
Country
Czechia
Facility Name
Research Site
City
Ostrava - Trebovice
Country
Czechia
Facility Name
Research Site
City
Praha 2
Country
Czechia
Facility Name
Research Site
City
Praha 4
Country
Czechia
Facility Name
Research Site
City
Uherske Hradiste
Country
Czechia
Facility Name
Research Site
City
Zlin
Country
Czechia
Facility Name
Research Site
City
Tallinn
Country
Estonia
Facility Name
Research Site
City
Köln
Country
Germany
Facility Name
Research Site
City
Magdeburg
Country
Germany
Facility Name
Research Site
City
Athens
Country
Greece
Facility Name
Research Site
City
Larissa
Country
Greece
Facility Name
Research Site
City
Baja
Country
Hungary
Facility Name
Research Site
City
Balatonfured
Country
Hungary
Facility Name
Research Site
City
Budapest
Country
Hungary
Facility Name
Research Site
City
Debrecen
Country
Hungary
Facility Name
Research Site
City
Ashkelon
Country
Israel
Facility Name
Research Site
City
Kfar-Saba
Country
Israel
Facility Name
Research Site
City
Petach-Tikva
Country
Israel
Facility Name
Research Site
City
Merida
Country
Mexico
Facility Name
Research Site
City
Gdynia
Country
Poland
Facility Name
Research Site
City
Grodzisk Mazowiecki
Country
Poland
Facility Name
Research Site
City
Katowice
Country
Poland
Facility Name
Research Site
City
Krakow
Country
Poland
Facility Name
Research Site
City
Wroclaw
Country
Poland
Facility Name
Research Site
City
Barnaul
Country
Russian Federation
Facility Name
Research Site
City
Kazan
Country
Russian Federation
Facility Name
Research Site
City
Moscow
Country
Russian Federation
Facility Name
Research Site
City
St. Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Yaroslavl
Country
Russian Federation
Facility Name
Research Site
City
Belgrade
Country
Serbia
Facility Name
Research Site
City
Niska Banja
Country
Serbia
Facility Name
Research Site
City
Bratislava
Country
Slovakia
Facility Name
Research Site
City
Durban
Country
South Africa
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Santiago de Compostela
Country
Spain
Facility Name
Research Site
City
Donetsk
Country
Ukraine
Facility Name
Research Site
City
Kharkiv
Country
Ukraine
Facility Name
Research Site
City
Kiev
Country
Ukraine
Facility Name
Research Site
City
Lutsk
Country
Ukraine
Facility Name
Research Site
City
Vinnytsia
Country
Ukraine
Facility Name
Research Site
City
Edinburgh
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29361199
Citation
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.
Results Reference
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A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

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