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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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