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

Rheumatoid Arthritis Clinical Trial

Official title:

An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01712399
• Other study ID #: CD-IA-CAM-3001-1109
• Secondary ID: Earth Explorer X
• Status: Terminated
• Phase: Phase 2
• First received: October 19, 2012
• Last updated: May 30, 2017
• Start date: January 28, 2013
• Est. completion date: December 30, 2015

Study information

• Verified date: May 2017
• Source: MedImmune LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 409
• Est. completion date: December 30, 2015
• Est. primary completion date: December 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 79 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma Buenos Aires
Argentina	Research Site	Ciudad Autonoma de Buenos Aire
Argentina	Research Site	Rosario
Argentina	Research Site	San Miguel de Tucuman
Bulgaria	Research Site	Plovdiv
Bulgaria	Research Site	Sofia
Chile	Research Site	Santiago
Chile	Research Site	Vina del Mar
Colombia	Research Site	Barranquilla
Czechia	Research Site	Bruntal
Czechia	Research Site	Jihlava
Czechia	Research Site	Ostrava - Trebovice
Czechia	Research Site	Praha 2
Czechia	Research Site	Praha 4
Czechia	Research Site	Uherske Hradiste
Czechia	Research Site	Zlin
Estonia	Research Site	Tallinn
Germany	Research Site	Köln
Germany	Research Site	Magdeburg
Greece	Research Site	Athens
Greece	Research Site	Larissa
Hungary	Research Site	Baja
Hungary	Research Site	Balatonfured
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Israel	Research Site	Ashkelon
Israel	Research Site	Kfar-Saba
Israel	Research Site	Petach-Tikva
Mexico	Research Site	Merida
Poland	Research Site	Gdynia
Poland	Research Site	Grodzisk Mazowiecki
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Wroclaw
Russian Federation	Research Site	Barnaul
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	St. Petersburg
Russian Federation	Research Site	Yaroslavl
Serbia	Research Site	Belgrade
Serbia	Research Site	Niska Banja
Slovakia	Research Site	Bratislava
South Africa	Research Site	Durban
Spain	Research Site	Barcelona
Spain	Research Site	Malaga
Spain	Research Site	Santiago de Compostela
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lutsk
Ukraine	Research Site	Vinnytsia
United Kingdom	Research Site	Edinburgh
United Kingdom	Research Site	London

Sponsors (1)

Lead Sponsor	Collaborator
MedImmune LLC

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Chile,  Colombia,  Czechia,  Estonia,  Germany,  Greece,  Hungary,  Israel,  Mexico,  Poland,  Russian Federation,  Serbia,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From Week 12 to Week 156 at specified time points