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

This study has been terminated.
(The study was terminated after approximately 3 years due to future clinical development plans, including ethical considerations.)
Sponsor:
Information provided by (Responsible Party):
MedImmune LLC
ClinicalTrials.gov Identifier:
NCT01712399
First received: October 19, 2012
Last updated: May 30, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Rheumatoid Arthritis Biological: Mavrilimumab 100 mg Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by MedImmune LLC:

Primary Outcome Measures:
  • 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.


Enrollment: 409
Study Start Date: January 28, 2013
Study Completion Date: December 30, 2015
Primary Completion Date: December 30, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
Biological: Mavrilimumab 100 mg
Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years

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.
  Eligibility

Ages Eligible for Study:   19 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712399

  Show 53 Study Locations
Sponsors and Collaborators
MedImmune LLC
  More Information

Responsible Party: MedImmune LLC
ClinicalTrials.gov Identifier: NCT01712399     History of Changes
Other Study ID Numbers: CD-IA-CAM-3001-1109
Earth Explorer X ( Other Identifier: MedImmune )
Study First Received: October 19, 2012
Results First Received: February 28, 2017
Last Updated: May 30, 2017

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 28, 2017