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History of Changes for Study: NCT01712399
A Long Term Safety Study of Mavrilimumab in Adult Subjects With Rheumatoid Arthritis
Latest version (submitted May 30, 2017) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 19, 2012 None (earliest Version on record)
2 December 5, 2012 Study Status and Contacts/Locations
3 January 16, 2013 Study Status
4 March 7, 2013 Recruitment Status, Study Status and Contacts/Locations
5 April 23, 2013 Contacts/Locations and Study Status
6 June 4, 2013 Study Status and Contacts/Locations
7 July 15, 2013 Study Status and Contacts/Locations
8 August 13, 2013 Contacts/Locations and Study Status
9 September 24, 2013 Contacts/Locations and Study Status
10 December 10, 2013 Study Status and Contacts/Locations
11 February 6, 2014 Contacts/Locations and Study Status
12 April 16, 2014 Contacts/Locations and Study Status
13 October 31, 2014 Contacts/Locations and Study Status
14 January 20, 2015 Contacts/Locations and Study Status
15 May 8, 2015 Recruitment Status, Study Status and Contacts/Locations
16 August 19, 2015 Study Status
17 November 24, 2015 Study Status, Eligibility and Study Identification
18 February 1, 2016 Recruitment Status, Study Status and Study Design
19 May 30, 2017 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations, Eligibility, Results, Outcome Measures, Study Description and Oversight
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Study NCT01712399
Submitted Date:  October 19, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: CD-IA-CAM-3001-1109
Brief Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2012
Overall Status: Not yet recruiting
Study Start: December 2012
Primary Completion: January 2019 [Anticipated]
Study Completion: February 2019 [Anticipated]
First Submitted: October 19, 2012
First Submitted that
Met QC Criteria:
October 19, 2012
First Posted: October 23, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
October 19, 2012
Last Update Posted: October 23, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: MedImmune LLC
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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 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.
Open or close this module Conditions
Conditions: Rheumatoid Arthritis
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: mavrilimumab Q2W + MTX
GM-CSFR alpha inhibitor
Biological: mavrilimumab subcutaneous Injection
GM-CSFR alpha inhibitor
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Safety and Tolerability
[ Time Frame: Informed consent through to approximately 5 year total ]

The occurrence of AEs and SAEs
2. Safety and Tolerability
[ Time Frame: Various timepoints from Day 1 through to approximately 5 years ]

Vital sign measurements - blood pressure, heart rate, temperature, respiratory rate
3. Safety and Tolerability
[ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ]

Clinical lab measurements - chemistry and hematology
4. Safety and Tolerability
[ Time Frame: From Day 1 (pre-dose) through to approximately 5 year total ]

Pulmonary function tests and dyspnoea score
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: MedImmune Medical Advisor
Email: clinicaltrialenquiries@medimmune.com
Central Contact Backup: MedImmune Senior Clinical Scientist
Email: clinicaltrialenquiries@medimmune.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:

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