A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
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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 subcutaneous Injection |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Extension Study to Evaluate the Long-term Safety of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis |
- Safety and Tolerability [ Time Frame: Informed consent through to approximately 5 year total ] [ Designated as safety issue: Yes ]The occurrence of AEs and SAEs
- Safety and Tolerability [ Time Frame: Various timepoints from Day 1 through to approximately 5 years ] [ Designated as safety issue: Yes ]Vital sign measurements - blood pressure, heart rate, temperature, respiratory rate
- Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ] [ Designated as safety issue: Yes ]Clinical lab measurements - chemistry and hematology
- Safety and Tolerability [ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ] [ Designated as safety issue: Yes ]Pulmonary function tests and dyspnoea score
| Estimated Enrollment: | 400 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | March 2019 |
| Estimated Primary Completion Date: | January 2019 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: mavrilimumab Q2W + MTX
GM-CSFR alpha inhibitor
|
Biological: mavrilimumab subcutaneous Injection
GM-CSFR alpha inhibitor
|
Detailed Description:
Despite the therapeutic improvements with recent biologic agents approved for rheumatoid arthritis (RA), there is still 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: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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| Contact: MedImmune Medical Advisor | clinicaltrialenquiries@medimmune.com | |
| Contact: MedImmune Senior Clinical Scientist | clinicaltrialenquiries@medimmune.com |
Show 30 Study Locations More Information
No publications provided
| Responsible Party: | MedImmune LLC |
| ClinicalTrials.gov Identifier: | NCT01712399 History of Changes |
| Other Study ID Numbers: | CD-IA-CAM-3001-1109 |
| Study First Received: | October 19, 2012 |
| Last Updated: | June 4, 2013 |
| Health Authority: | United States: Food and Drug Administration |
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 Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013