Clinical trial NCT01712399: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 409
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
timeFrame: From the start of study drug administration up to 12 weeks after the last dose of study drug (approximately up to 3 years)
measure: Number of Participants With Clinical Laboratory Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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)
measure: Number of Participants With Vital Sign Abnormalities Reported as Treatment-Emergent Adverse Events (TEAEs)
timeFrame: 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)
measure: Number of Participants With Abnormal Electrocardiogram (ECG) Findings Reported as TEAEs
timeFrame: 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)
measure: Number of Participants With Forced Expiratory Volume in 1 Second (FEV1) Outside Threshold Values
timeFrame: From Week 24 to Week 130 at specified time points
measure: Number of Participants With Forced Expiratory Volume in 6 Seconds (FEV6) Outside Threshold Values
timeFrame: From Week 24 to Week 130 at specified time points
measure: Number of Participants With Forced Vital Capacity (FVC) Outside Threshold Values
timeFrame: From Week 24 to Week 156 at specified time points
measure: Number of Participants With Clinically Meaningful Change in Borg Dyspnea Score Considered as an AE
timeFrame: From Week 0 to Week 132 at specified time points
measure: Oxygen Saturation Levels by Pulse Oximetry
timeFrame: From Week 0 to Week 132 at specified time points
measure: Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)
timeFrame: From Week 12 to Week 156 at specified time points
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Research Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Vina del Mar
country: Chile
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bruntal
country: Czechia
facility: Research Site
city: Jihlava
country: Czechia
facility: Research Site
city: Ostrava - Trebovice
country: Czechia
facility: Research Site
city: Praha 2
country: Czechia
facility: Research Site
city: Praha 4
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Zlin
country: Czechia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Köln
country: Germany
facility: Research Site
city: Magdeburg
country: Germany
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Larissa
country: Greece
facility: Research Site
city: Baja
country: Hungary
facility: Research Site
city: Balatonfured
country: Hungary
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Ashkelon
country: Israel
facility: Research Site
city: Kfar-Saba
country: Israel
facility: Research Site
city: Petach-Tikva
country: Israel
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Grodzisk Mazowiecki
country: Poland
facility: Research Site
city: Katowice
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Niska Banja
country: Serbia
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Malaga
country: Spain
facility: Research Site
city: Santiago de Compostela
country: Spain
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
References:
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.