A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Status and phase
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Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
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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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
409 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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